James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
DIY Scientists Hack the Software of Life, Marcus Wohlsen explores the new movement in garage-based biotech. By Amanda Gefter.
For most of us, managing our health means visiting a doctor. The more serious our concerns, the more specialized a medical expert we seek. Our bodies often feel like foreign and frightening lands, and we are happy to let someone with an MD serve as our tour guide. For most of us, our own DNA never makes it onto our personal reading list.
http://www.openpr.com/news/172549/Harris-James-Associates-Biomedicine-News-Can-Hobbyists-and-Hackers-Transform-Biotechnology.html
Viser innlegg med etiketten harris james associates new york usa reviews. Vis alle innlegg
Viser innlegg med etiketten harris james associates new york usa reviews. Vis alle innlegg
søndag 1. mai 2011
Harris James Associates Update: Congressional forum on biotech jobs focuses on FDA
Harris James Associates Update: Overly cautious government regulators, threats to basic science research funding and burdensome taxes are holding back job creation by drug and medical device companies and slowing the delivery of innovative new therapies to patients, biotechnology industry experts told federal lawmakers Thursday during a hearing in San Diego.
James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
Most of the criticism was directed at the Food and Drug Administration, which approved 21 new drugs last year, compared to 36 in 2004.
“There are whole areas (of drug development) that venture capitalists won’t pursue because the regulatory barriers are too high,” said David Gollaher, president and chief executive of the California Healthcare Institute in La Jolla.
The complaints were familiar to anyone who has followed drug and medical device development in the United States over the past several years.
Gollaher and the other experts delivered their comments to Rep. Darrell Issa, R-Vista, during a morning public forum at the University of California San Diego. Since he became chairman of the House Oversight and Government Reform Committee in early January, Issa has hosted 10 such gatherings around the country focused on regulations that stifle economic expansion.
For the latest gathering, he returned to his home county, where more than 400 companies make up a major biotechnology hub that employs more than 40,000 people, according to the San Diego trade group Biocom.
Issa was joined by Reps. Susan Davis, D-San Diego; Brian Bilbray, R-Solana Beach; and Duncan Hunter, R-Alpine.
Issa’s committee has broad investigative power, but any legislation addressing specific regulatory changes would be handled by other congressional panels that directly oversee the related agencies.
“We’re here today because San Diego is a miraculous story of biotech,” Issa said in comments that opened the 1½-hour session.
To aid his investigation, Issa solicited comments from hundreds of individuals, companies and trade groups, including many in the biotechnology and pharmaceutical industries, both directly and through a special website, americanjobcreators.com.
“We were shocked to find out that the FDA is often one of the greatest impediments to job creation,” the congressman said.
Critics of the agency say the problem is most clearly displayed in the increasing amount of time that it takes the agency to process new product applications.
Since 2007, drug review times by the FDA have increased by 28 percent, while evaluations of devices have taken as much as 75 percent more time, Gollaher said.
http://www.onlineprnews.com/news/131306-1303817804-harris-james-associates-update-congressional-forum-on-biotech-jobs-focuses-on-fda-by-keith-darc.html
James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
Most of the criticism was directed at the Food and Drug Administration, which approved 21 new drugs last year, compared to 36 in 2004.
“There are whole areas (of drug development) that venture capitalists won’t pursue because the regulatory barriers are too high,” said David Gollaher, president and chief executive of the California Healthcare Institute in La Jolla.
The complaints were familiar to anyone who has followed drug and medical device development in the United States over the past several years.
Gollaher and the other experts delivered their comments to Rep. Darrell Issa, R-Vista, during a morning public forum at the University of California San Diego. Since he became chairman of the House Oversight and Government Reform Committee in early January, Issa has hosted 10 such gatherings around the country focused on regulations that stifle economic expansion.
For the latest gathering, he returned to his home county, where more than 400 companies make up a major biotechnology hub that employs more than 40,000 people, according to the San Diego trade group Biocom.
Issa was joined by Reps. Susan Davis, D-San Diego; Brian Bilbray, R-Solana Beach; and Duncan Hunter, R-Alpine.
Issa’s committee has broad investigative power, but any legislation addressing specific regulatory changes would be handled by other congressional panels that directly oversee the related agencies.
“We’re here today because San Diego is a miraculous story of biotech,” Issa said in comments that opened the 1½-hour session.
To aid his investigation, Issa solicited comments from hundreds of individuals, companies and trade groups, including many in the biotechnology and pharmaceutical industries, both directly and through a special website, americanjobcreators.com.
“We were shocked to find out that the FDA is often one of the greatest impediments to job creation,” the congressman said.
Critics of the agency say the problem is most clearly displayed in the increasing amount of time that it takes the agency to process new product applications.
Since 2007, drug review times by the FDA have increased by 28 percent, while evaluations of devices have taken as much as 75 percent more time, Gollaher said.
http://www.onlineprnews.com/news/131306-1303817804-harris-james-associates-update-congressional-forum-on-biotech-jobs-focuses-on-fda-by-keith-darc.html
Harris James Associates News: Nautic Partners buys Omnicare Clinical Research
Private equity firm Nautic Partners acquired Omnicare Clinical Research on Thursday.
Harris James Associates News Compilation - JHA mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
Omnicare CR, headquartered in King of Prussia, Pa., conducts early phase, phase II, III and late phase clinical trials for pharmaceutical, biotechnology and medical device industries. It also provides technical services supporting clinical trials, with a focus on data management and biostatistics services.
As part of the deal, its parent company, Ominicare Inc., has provided Omnicare CR with access to its proprietary database of de-identified information exclusive to the field of clinical research and lasting for five years.
“Omnicare has carved out an attractive niche in the [clinical research organization] industry as a global, full-service provider serving the mid-sized pharmaceutical market, the medical device market and the biotechnology market,” said Chris Crosby, managing director of Nautic. The firm did not disclose the financial details of the acquisition.
http://www.onlineprnews.com/news/133166-1304057284-harris-james-associates-news-nautic-partners-buys-omnicare-clinical-research.html
Harris James Associates News Compilation - JHA mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
Omnicare CR, headquartered in King of Prussia, Pa., conducts early phase, phase II, III and late phase clinical trials for pharmaceutical, biotechnology and medical device industries. It also provides technical services supporting clinical trials, with a focus on data management and biostatistics services.
As part of the deal, its parent company, Ominicare Inc., has provided Omnicare CR with access to its proprietary database of de-identified information exclusive to the field of clinical research and lasting for five years.
“Omnicare has carved out an attractive niche in the [clinical research organization] industry as a global, full-service provider serving the mid-sized pharmaceutical market, the medical device market and the biotechnology market,” said Chris Crosby, managing director of Nautic. The firm did not disclose the financial details of the acquisition.
http://www.onlineprnews.com/news/133166-1304057284-harris-james-associates-news-nautic-partners-buys-omnicare-clinical-research.html
Harris James Associates News: Nautic Partners buys Omnicare Clinical Research
Harris James Associates News Compilation - JHA mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
Omnicare CR, headquartered in King of Prussia, Pa., conducts early phase, phase II, III and late phase clinical trials for pharmaceutical, biotechnology and medical device industries. It also provides technical services supporting clinical trials, with a focus on data management and biostatistics services.
As part of the deal, its parent company, Ominicare Inc., has provided Omnicare CR with access to its proprietary database of de-identified information exclusive to the field of clinical research and lasting for five years.
“Omnicare has carved out an attractive niche in the [clinical research organization] industry as a global, full-service provider serving the mid-sized pharmaceutical market, the medical device market and the biotechnology market,” said Chris Crosby, managing director of Nautic. The firm did not disclose the financial details of the acquisition.
It is the 10th investment by Nautic Partners’ most recent fund, Nautic Partners VI, and its third health care investment.
http://www.widepr.com/press_release/12227/harris_james_associates_news_nautic_partners_buys_omnicare_clinical_research.html
Omnicare CR, headquartered in King of Prussia, Pa., conducts early phase, phase II, III and late phase clinical trials for pharmaceutical, biotechnology and medical device industries. It also provides technical services supporting clinical trials, with a focus on data management and biostatistics services.
As part of the deal, its parent company, Ominicare Inc., has provided Omnicare CR with access to its proprietary database of de-identified information exclusive to the field of clinical research and lasting for five years.
“Omnicare has carved out an attractive niche in the [clinical research organization] industry as a global, full-service provider serving the mid-sized pharmaceutical market, the medical device market and the biotechnology market,” said Chris Crosby, managing director of Nautic. The firm did not disclose the financial details of the acquisition.
It is the 10th investment by Nautic Partners’ most recent fund, Nautic Partners VI, and its third health care investment.
http://www.widepr.com/press_release/12227/harris_james_associates_news_nautic_partners_buys_omnicare_clinical_research.html
Harris James Associates News: Nautic Partners buys Omnicare Clinical Research
Harris James Associates News Compilation - JHA mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
Omnicare CR, headquartered in King of Prussia, Pa., conducts early phase, phase II, III and late phase clinical trials for pharmaceutical, biotechnology and medical device industries. It also provides technical services supporting clinical trials, with a focus on data management and biostatistics services.
As part of the deal, its parent company, Ominicare Inc., has provided Omnicare CR with access to its proprietary database of de-identified information exclusive to the field of clinical research and lasting for five years.
“Omnicare has carved out an attractive niche in the [clinical research organization] industry as a global, full-service provider serving the mid-sized pharmaceutical market, the medical device market and the biotechnology market,” said Chris Crosby, managing director of Nautic. The firm did not disclose the financial details of the acquisition.
It is the 10th investment by Nautic Partners’ most recent fund, Nautic Partners VI, and its third health care investment.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
http://www.libervis.com/topic/harris-james-associates-news-nautic-partners-buys-omnicare-clinical-research
Omnicare CR, headquartered in King of Prussia, Pa., conducts early phase, phase II, III and late phase clinical trials for pharmaceutical, biotechnology and medical device industries. It also provides technical services supporting clinical trials, with a focus on data management and biostatistics services.
As part of the deal, its parent company, Ominicare Inc., has provided Omnicare CR with access to its proprietary database of de-identified information exclusive to the field of clinical research and lasting for five years.
“Omnicare has carved out an attractive niche in the [clinical research organization] industry as a global, full-service provider serving the mid-sized pharmaceutical market, the medical device market and the biotechnology market,” said Chris Crosby, managing director of Nautic. The firm did not disclose the financial details of the acquisition.
It is the 10th investment by Nautic Partners’ most recent fund, Nautic Partners VI, and its third health care investment.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
http://www.libervis.com/topic/harris-james-associates-news-nautic-partners-buys-omnicare-clinical-research
Harris James Associates – Our Strategy
We believe strongly in the concept of economic and market-led research. This "top down" approach is aimed at identifying the most vibrant and promising market sectors in which to direct its considerable industry and company research capabilities. We believe in the long term growth and development of the global economy as the world's people strive for a healthier and higher standard of living, particularly in those emerging economies that account for fully half of the global population. While there are many and varied stumbling blocks on the path of global economic and social progress, Harris James Associates recognizes that there are always sectors that exhibit superior potential in the dynamics of global development. We believe that selectivity is the key to long term investment success in the stock market......
Portfolio Balancing
Rebalancing a person's investment decision profile can become a vital need due to private lifestyle adjustments for instance age, earnings, pension, inheritances, or even purchase or sale of a property or another significant property such as property, brand new assets requirements, as well as an modification in private associated risk threshold, and so on. As well, rebalancing is often required as a result of changes in asset allocation due to altered investment expectations, or to realign portfolio weightings in line with target allocations due to changing values of individual portfolio holdings. As part of the HJA commitment to excellence, and our focus on unparalleled client service, your HJA Account Executive will routinely monitor, and provide assistance when portfolio rebalancing is advised.
Timely Advice
Whether one is a seasoned investor or a newcomer to the world of private investing, your HJA representative is prepared to assist in any way practical. Advice regarding any or all aspects of your personal investment program, its overall wealth building strategy and tactical recommendations in light of changing market circumstances is yours for the asking. When Harris James Associates research discovers a compelling stock investment that meets with your overall objectives, you will be advised in a timely manner so that you may consider it for your portfolio without undue delay. Or when changing circumstances suggest a liquidation of a given investment, and because you are the ultimate decision maker, we will advise you of such changes with all practical haste.
MERGERS and ACQUISITIONS - Maximizing Your Value
Harris James Associates offers a comprehensive range of Merger and Acquisition services to help you identify strategic opportunities and develop and execute integration plans, including:
Business due diligence
Integration strategy check
Post-merger integration plan management
Harris James Associates have worked with a lot of businesses in all key industries on national and cross-border merger and acquisition projects. With our extensive consulting, technology and outsourcing expertise, clients can expect a smooth and efficient integration that yields positive results. Discover what we can do for your business.
Business due diligence
http://www.pressbox.co.uk/detailed/Business/Harris_James_Associates_Our_Strategy_656036.html
Portfolio Balancing
Rebalancing a person's investment decision profile can become a vital need due to private lifestyle adjustments for instance age, earnings, pension, inheritances, or even purchase or sale of a property or another significant property such as property, brand new assets requirements, as well as an modification in private associated risk threshold, and so on. As well, rebalancing is often required as a result of changes in asset allocation due to altered investment expectations, or to realign portfolio weightings in line with target allocations due to changing values of individual portfolio holdings. As part of the HJA commitment to excellence, and our focus on unparalleled client service, your HJA Account Executive will routinely monitor, and provide assistance when portfolio rebalancing is advised.
Timely Advice
Whether one is a seasoned investor or a newcomer to the world of private investing, your HJA representative is prepared to assist in any way practical. Advice regarding any or all aspects of your personal investment program, its overall wealth building strategy and tactical recommendations in light of changing market circumstances is yours for the asking. When Harris James Associates research discovers a compelling stock investment that meets with your overall objectives, you will be advised in a timely manner so that you may consider it for your portfolio without undue delay. Or when changing circumstances suggest a liquidation of a given investment, and because you are the ultimate decision maker, we will advise you of such changes with all practical haste.
MERGERS and ACQUISITIONS - Maximizing Your Value
Harris James Associates offers a comprehensive range of Merger and Acquisition services to help you identify strategic opportunities and develop and execute integration plans, including:
Business due diligence
Integration strategy check
Post-merger integration plan management
Harris James Associates have worked with a lot of businesses in all key industries on national and cross-border merger and acquisition projects. With our extensive consulting, technology and outsourcing expertise, clients can expect a smooth and efficient integration that yields positive results. Discover what we can do for your business.
Business due diligence
http://www.pressbox.co.uk/detailed/Business/Harris_James_Associates_Our_Strategy_656036.html
Harris James Associates Update: Congressional forum on biotech jobs focuses on FDA
Harris James Associates Update: Overly cautious government regulators, threats to basic science research funding and burdensome taxes are holding back job creation by drug and medical device companies and slowing the delivery of innovative new therapies to patients, biotechnology industry experts told federal lawmakers Thursday during a hearing in San Diego. James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful. Most of the criticism was directed at the Food and Drug Administration, which approved 21 new drugs last year, compared to 36 in 2004.
"There are whole areas (of drug development) that venture capitalists won't pursue because the regulatory barriers are too high," said David Gollaher, president and chief executive of the California Healthcare Institute in La Jolla. The complaints were familiar to anyone who has followed drug and medical device development in the United States over the past several years. Gollaher and the other experts delivered their comments to Rep. Darrell Issa, R-Vista, during a morning public forum at the University of California San Diego. Since he became chairman of the House Oversight and Government Reform Committee in early January, Issa has hosted 10 such gatherings around the country focused on regulations that stifle economic expansion. For the latest gathering, he returned to his home county, where more than 400 companies make up a major biotechnology hub that employs more than 40,000 people, according to the San Diego trade group Biocom. Issa was joined by Reps.
Susan Davis, D-San Diego; Brian Bilbray, R-Solana Beach; and Duncan Hunter, R-Alpine. Issa's committee has broad investigative power, but any legislation addressing specific regulatory changes would be handled by other congressional panels that directly oversee the related agencies. "We're here today because San Diego is a miraculous story of biotech," Issa said in comments that opened the 1½-hour session. To aid his investigation, Issa solicited comments from hundreds of individuals, companies and trade groups, including many in the biotechnology and pharmaceutical industries, both directly and through a special website, americanjobcreators.com. "We were shocked to find out that the FDA is often one of the greatest impediments to job creation," the congressman said.
Critics of the agency say the problem is most clearly displayed in the increasing amount of time that it takes the agency to process new product applications. Since 2007, drug review times by the FDA have increased by 28 percent, while evaluations of devices have taken as much as 75 percent more time, Gollaher said. They also point to a recent string of unexpected new drug rejections by the agency that forced developers to perform new tests on their experimental medications. Just in the past six months, the FDA turned down three drugs from San Diego companies: diet pills from Arena Pharmaceuticals and Orexigen Therapeutics, and a weekly injectable diabetes therapy from Amylin. In a recent survey by Biocom, industry executives said the agency's review process lacks transparency, often becomes sidetracked by unexpected issues and takes too much time.
http://www.release-news.com/index.php/finance/95748-harris-james-associates-update-congressional-forum-on-biotech-jobs-focuses-on-fda-by-keith-darce.html
"There are whole areas (of drug development) that venture capitalists won't pursue because the regulatory barriers are too high," said David Gollaher, president and chief executive of the California Healthcare Institute in La Jolla. The complaints were familiar to anyone who has followed drug and medical device development in the United States over the past several years. Gollaher and the other experts delivered their comments to Rep. Darrell Issa, R-Vista, during a morning public forum at the University of California San Diego. Since he became chairman of the House Oversight and Government Reform Committee in early January, Issa has hosted 10 such gatherings around the country focused on regulations that stifle economic expansion. For the latest gathering, he returned to his home county, where more than 400 companies make up a major biotechnology hub that employs more than 40,000 people, according to the San Diego trade group Biocom. Issa was joined by Reps.
Susan Davis, D-San Diego; Brian Bilbray, R-Solana Beach; and Duncan Hunter, R-Alpine. Issa's committee has broad investigative power, but any legislation addressing specific regulatory changes would be handled by other congressional panels that directly oversee the related agencies. "We're here today because San Diego is a miraculous story of biotech," Issa said in comments that opened the 1½-hour session. To aid his investigation, Issa solicited comments from hundreds of individuals, companies and trade groups, including many in the biotechnology and pharmaceutical industries, both directly and through a special website, americanjobcreators.com. "We were shocked to find out that the FDA is often one of the greatest impediments to job creation," the congressman said.
Critics of the agency say the problem is most clearly displayed in the increasing amount of time that it takes the agency to process new product applications. Since 2007, drug review times by the FDA have increased by 28 percent, while evaluations of devices have taken as much as 75 percent more time, Gollaher said. They also point to a recent string of unexpected new drug rejections by the agency that forced developers to perform new tests on their experimental medications. Just in the past six months, the FDA turned down three drugs from San Diego companies: diet pills from Arena Pharmaceuticals and Orexigen Therapeutics, and a weekly injectable diabetes therapy from Amylin. In a recent survey by Biocom, industry executives said the agency's review process lacks transparency, often becomes sidetracked by unexpected issues and takes too much time.
http://www.release-news.com/index.php/finance/95748-harris-james-associates-update-congressional-forum-on-biotech-jobs-focuses-on-fda-by-keith-darce.html
Harris James Associates Biomedicine News: Can Hobbyists and Hackers Transform Biotechnology?
James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
DIY Scientists Hack the Software of Life, Marcus Wohlsen explores the new movement in garage-based biotech. By Amanda Gefter.
For most of us, managing our health means visiting a doctor. The more serious our concerns, the more specialized a medical expert we seek. Our bodies often feel like foreign and frightening lands, and we are happy to let someone with an MD serve as our tour guide. For most of us, our own DNA never makes it onto our personal reading list.
http://openpr.com/news/172549/Harris-James-Associates-Biomedicine-News-Can-Hobbyists-and-Hackers-Transform-Biotechnology.html
DIY Scientists Hack the Software of Life, Marcus Wohlsen explores the new movement in garage-based biotech. By Amanda Gefter.
For most of us, managing our health means visiting a doctor. The more serious our concerns, the more specialized a medical expert we seek. Our bodies often feel like foreign and frightening lands, and we are happy to let someone with an MD serve as our tour guide. For most of us, our own DNA never makes it onto our personal reading list.
http://openpr.com/news/172549/Harris-James-Associates-Biomedicine-News-Can-Hobbyists-and-Hackers-Transform-Biotechnology.html
Harris James Associates
Contact Us
80 Broad Street, New York City, New York 10004, United StatesTel # 1 917 3381687 Fax # 1 917 5917329 Email: info@harrisjamesassociates.com
Harris James Associates Compiled News: Young Biotech Firms Seek Long Term Relevance
James Harris Associates mission is to embrace our client’s goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
The Bedford Report Provides Analyst Research on Vivus and Avanir Pharmaceuticals
NEW YORK, NY–(Marketwire – April 18, 2011) – There is plenty of optimism surrounding the biotech sector as firmer pricing and new products have improved sales and earnings trends. Meanwhile, younger, more speculative firms continue to garner significant attention with potential blockbuster products working their way through the regulatory process. The Bedford Report examines the outlook for companies in the Biotechnology Industry and provides research reports on Vivus, Inc. (NASDAQ: VVUS) and Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR). Access to the full company reports can be found at:
www.bedfordreport.com/2011-04-VVUS
www.bedfordreport.com/2011-04-AVNR
IMS Health, a leading research and analytical firm serving the pharmaceutical and medical industries, projects an increase in worldwide biotech growth in 2011 of between 5 and 7 percent, with a similar outlook stretching out to 2015. Emerging markets such as China, India, and Brazil are expected to contribute significantly to this growth. Sales growth of 15 percent is forecast in emerging markets, many of which are benefitting from increased government spending on healthcare and broader private health coverage for workers.
The Bedford Report releases regular market updates on the Healthcare Sector so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at www.bedfordreport.com and get exclusive access to our numerous analyst reports and industry newsletters.
Earlier this month shares of Vivus surged after the company released a study that may prompt US regulators to approve its weight loss drug, Qnexa. According to research presented at the American College of Cardiology meeting in New Orleans, Vivus’s once-daily pill helped people reduce dependence on blood pressure pills and decrease their triglycerides.
In October the FDA declined to approve Qnexa and asked for more study results and additional information about possible health risks, including major cardiovascular events. The FDA also has said new clinical trials might not be required to satisfy a request for more information about the drug or for it to eventually gain approval.
Also this month Avanir Pharmaceuticals filed an Investigational New Drug application with the Food and Drug Administration to begin a Phase II trial for its investigational drug, AVP-923, in the treatment of central neuropathic pain in patients with multiple sclerosis.
The Bedford Report provides Analyst Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. The Bedford Report has not been compensated by any of the above-mentioned publicly traded companies. The Bedford Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at http://www.bedfordreport.com/disclaimer.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
http://www.your-story.org/harris-james-associates-compiled-news-young-biotech-firms-seek-long-term-relevance-238750/
The Bedford Report Provides Analyst Research on Vivus and Avanir Pharmaceuticals
NEW YORK, NY–(Marketwire – April 18, 2011) – There is plenty of optimism surrounding the biotech sector as firmer pricing and new products have improved sales and earnings trends. Meanwhile, younger, more speculative firms continue to garner significant attention with potential blockbuster products working their way through the regulatory process. The Bedford Report examines the outlook for companies in the Biotechnology Industry and provides research reports on Vivus, Inc. (NASDAQ: VVUS) and Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR). Access to the full company reports can be found at:
www.bedfordreport.com/2011-04-VVUS
www.bedfordreport.com/2011-04-AVNR
IMS Health, a leading research and analytical firm serving the pharmaceutical and medical industries, projects an increase in worldwide biotech growth in 2011 of between 5 and 7 percent, with a similar outlook stretching out to 2015. Emerging markets such as China, India, and Brazil are expected to contribute significantly to this growth. Sales growth of 15 percent is forecast in emerging markets, many of which are benefitting from increased government spending on healthcare and broader private health coverage for workers.
The Bedford Report releases regular market updates on the Healthcare Sector so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at www.bedfordreport.com and get exclusive access to our numerous analyst reports and industry newsletters.
Earlier this month shares of Vivus surged after the company released a study that may prompt US regulators to approve its weight loss drug, Qnexa. According to research presented at the American College of Cardiology meeting in New Orleans, Vivus’s once-daily pill helped people reduce dependence on blood pressure pills and decrease their triglycerides.
In October the FDA declined to approve Qnexa and asked for more study results and additional information about possible health risks, including major cardiovascular events. The FDA also has said new clinical trials might not be required to satisfy a request for more information about the drug or for it to eventually gain approval.
Also this month Avanir Pharmaceuticals filed an Investigational New Drug application with the Food and Drug Administration to begin a Phase II trial for its investigational drug, AVP-923, in the treatment of central neuropathic pain in patients with multiple sclerosis.
The Bedford Report provides Analyst Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. The Bedford Report has not been compensated by any of the above-mentioned publicly traded companies. The Bedford Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at http://www.bedfordreport.com/disclaimer.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
http://www.your-story.org/harris-james-associates-compiled-news-young-biotech-firms-seek-long-term-relevance-238750/
Harris James Associates Biomedicine News: Can Hobbyists and Hackers Transform Biotechnology?
James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
DIY Scientists Hack the Software of Life, Marcus Wohlsen explores the new movement in garage-based biotech. By Amanda Gefter.
For most of us, managing our health means visiting a doctor. The more serious our concerns, the more specialized a medical expert we seek. Our bodies often feel like foreign and frightening lands, and we are happy to let someone with an MD serve as our tour guide. For most of us, our own DNA never makes it onto our personal reading list.
Biohackers are on a mission to change all that. These do-it-yourself biology hobbyists want to bring biotechnology out of institutional labs and into our homes. Following in the footsteps of revolutionaries like Steve Jobs and Steve Wozniak, who built the first Apple computer in Jobs's garage, and Sergey Brin and Larry Page, who invented Google in a friend's garage, biohackers are attempting bold feats of genetic engineering, drug development, and biotech research in makeshift home laboratories.
In Biopunk, journalist Marcus Wohlsen surveys the rising tide of the biohacker movement, which has been made possible by a convergence of better and cheaper technologies. For a few hundred dollars, anyone can send some spit to a sequencing company and receive a complete DNA scan, and then use free software to analyze the results. Custom-made DNA can be mail-ordered off websites, and affordable biotech gear is available on Craigslist and eBay.
Wohlson discovers that biohackers, like the open-source programmers and software hackers who came before, are united by a profound idealism. They believe in the power of individuals as opposed to corporate interests, in the wisdom of crowds as opposed to the single-mindedness of experts, and in the incentive to do good for the world as opposed to the need to turn a profit. Suspicious of scientific elitism and inspired by the success of open-source computing, the bio DIYers believe that individuals have a fundamental right to biological information, that spreading the tools of biotech to the masses will accelerate the pace of progress, and that the fruits of the biosciences should be delivered into the hands of the people who need them the most.
With all their ingenuity and idealism, it's difficult not to root for the biohackers Wohlsen meets. Take MIT grad student Kay Aull, who built her own genetic testing kit in her closet after her father was diagnosed with the hereditary disease hemochromatosis. "Aull's test does not represent new science but a new way of doing science," Wohlsen writes. Aull's self-test for the disease-causing mutation came back positive.
Or take Meredith Patterson, who is trying to create a cheap, decentralized way to test milk for melamine poisoning without relying on government regulators. Patterson has written a "Biopunk Manifesto" that reads in part, "Scientific literacy empowers everyone who possesses it to be active contributors to their own health care, the quality of their food, water and air, their very interactions with their own bodies and the complex world around them."
Biohackers Josh Perfetto and Tito Jankowski created OpenPCR, a cheap, hackable DNA Xerox machine (PCR stands for "polymerase chain reaction," the name for a method of replicating DNA). Interested biohackers can pre-order one for just over $500 or, once it's ready, download the blueprint free and make their own. According to the website, its apps include DNA sequencing and a test to "check that sushi is legit." Jankowski "hopes to introduce young people to the tools and techniques of biotech in a way that makes gene tweaking as much a part of everyday technology as texting," Wohlsen writes. Jankowski, together with Joseph Jackson and Eri Gentry, also founded BioCurious, a collaborative lab space for biohackers in the Bay area. "Got an idea for a startup? Join the DIY, 'garage biology' movement and found a new breed of biotech," their website exhorts.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
http://www.blochure.com/harris-james-associates-biomedicine-news-can-hobbyists-and-hackers-transform-biotechnology-3573/
DIY Scientists Hack the Software of Life, Marcus Wohlsen explores the new movement in garage-based biotech. By Amanda Gefter.
For most of us, managing our health means visiting a doctor. The more serious our concerns, the more specialized a medical expert we seek. Our bodies often feel like foreign and frightening lands, and we are happy to let someone with an MD serve as our tour guide. For most of us, our own DNA never makes it onto our personal reading list.
Biohackers are on a mission to change all that. These do-it-yourself biology hobbyists want to bring biotechnology out of institutional labs and into our homes. Following in the footsteps of revolutionaries like Steve Jobs and Steve Wozniak, who built the first Apple computer in Jobs's garage, and Sergey Brin and Larry Page, who invented Google in a friend's garage, biohackers are attempting bold feats of genetic engineering, drug development, and biotech research in makeshift home laboratories.
In Biopunk, journalist Marcus Wohlsen surveys the rising tide of the biohacker movement, which has been made possible by a convergence of better and cheaper technologies. For a few hundred dollars, anyone can send some spit to a sequencing company and receive a complete DNA scan, and then use free software to analyze the results. Custom-made DNA can be mail-ordered off websites, and affordable biotech gear is available on Craigslist and eBay.
Wohlson discovers that biohackers, like the open-source programmers and software hackers who came before, are united by a profound idealism. They believe in the power of individuals as opposed to corporate interests, in the wisdom of crowds as opposed to the single-mindedness of experts, and in the incentive to do good for the world as opposed to the need to turn a profit. Suspicious of scientific elitism and inspired by the success of open-source computing, the bio DIYers believe that individuals have a fundamental right to biological information, that spreading the tools of biotech to the masses will accelerate the pace of progress, and that the fruits of the biosciences should be delivered into the hands of the people who need them the most.
With all their ingenuity and idealism, it's difficult not to root for the biohackers Wohlsen meets. Take MIT grad student Kay Aull, who built her own genetic testing kit in her closet after her father was diagnosed with the hereditary disease hemochromatosis. "Aull's test does not represent new science but a new way of doing science," Wohlsen writes. Aull's self-test for the disease-causing mutation came back positive.
Or take Meredith Patterson, who is trying to create a cheap, decentralized way to test milk for melamine poisoning without relying on government regulators. Patterson has written a "Biopunk Manifesto" that reads in part, "Scientific literacy empowers everyone who possesses it to be active contributors to their own health care, the quality of their food, water and air, their very interactions with their own bodies and the complex world around them."
Biohackers Josh Perfetto and Tito Jankowski created OpenPCR, a cheap, hackable DNA Xerox machine (PCR stands for "polymerase chain reaction," the name for a method of replicating DNA). Interested biohackers can pre-order one for just over $500 or, once it's ready, download the blueprint free and make their own. According to the website, its apps include DNA sequencing and a test to "check that sushi is legit." Jankowski "hopes to introduce young people to the tools and techniques of biotech in a way that makes gene tweaking as much a part of everyday technology as texting," Wohlsen writes. Jankowski, together with Joseph Jackson and Eri Gentry, also founded BioCurious, a collaborative lab space for biohackers in the Bay area. "Got an idea for a startup? Join the DIY, 'garage biology' movement and found a new breed of biotech," their website exhorts.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
http://www.blochure.com/harris-james-associates-biomedicine-news-can-hobbyists-and-hackers-transform-biotechnology-3573/
Cricket: Glamorgan’s James Harris eyes England honours
Cricket: Glamorgan’s James Harris eyes England honours
Some of Glamorgan’s biggest names, including Gilbert Parkhouse, Peter Walker, Jeff Jones and teammate Robert Croft have represented England at Test match level and Harris is desperate to make the step up.
He believes touring with the England Lions, formerly England A, this winter gave him the perfect grounding for a call-up to the first team.
While Harris has already written his name into the Glamorgan record books for his feats as a fresh-faced teenager, he is now ready to push for full international honours.
His immediate focus is on getting Glamorgan’s championship season off to a winning start as they attempt to put the frustration of last year and the turbulent events off the field during the winter behind them.
For Harris, the early part of the off-season was spent at the National Cricket Performance Centre in Loughborough, ironing out the creases in his game before travelling to the Caribbean in January.
torsdag 28. april 2011
Harris James Associates Compiled News: Anthera Pharmaceuticals Successfully Completes Interim Biomarker Analysis
http://www.your-story.org/harris-james-associates-compiled-news-anthera-pharmaceuticals-successfully-completes-interim-biomarker-analysis-238749/
Anthera Pharmaceuticals Successfully Completes Interim Biomarker Analysis of VISTA-16 Study and Third Safety Review of Varespladib Methyl
James Harris Associates mission is to embrace our client’s goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
VISTA-16 Study to Continue Global Enrollment
HAYWARD, Calif., April 18, 2011 /PRNewswire/ — Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced that enrollment in the Phase 3 VISTA-16 study of varespladib in Acute Coronary Syndromes (ACS) will continue based on the positive outcome of an interim biomarker analysis and review of available patient safety data.
An independent statistician completed an analysis of various biomarkers of cardiovascular risk and determined that treatment with once-daily varespladib met the pre-specified criteria for the study to proceed. The analysis required patients on varespladib to demonstrate pre-defined treatment effects versus placebo at relevant time points on a collection of biomarkers including: secretory phospholipase A2 (sPLA2), low density lipoprotein cholesterol (LDL-C), C-reactive protein (CRP), interleukin-6 (IL-6), and a composite responder endpoint defined as patients achieving LDL-C less than 70 mg/dL and CRP below 1.0 mg/L.
In parallel with the biomarker analysis, the VISTA-16 independent Data Safety and Monitoring Board (DSMB) completed a review of the available safety database including all reported adverse events and serious adverse events and recommended the continuation of the VISTA-16 clinical study without modification. This represents the third meeting of DSMB since the start of the study.
“We continue to believe that positive changes in patient biomarkers similar to changes seen in the FRANCIS Phase 2 clinical study will correlate to a reduction in major adverse cardiovascular events in patients treated with varespladib for 16 weeks,” said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals. “We are hopeful this approach will eventually prove that rapid and safe reduction of inflammation following an acute coronary syndrome will translate into better treatment options for this high-risk patient population.”
“VISTA-16 represents an innovative approach based on years of extensive study of the negative effects of inflammation in patients with ACS”, commented Stephen J. Nicholls, M.D., Ph.D., Cardiovascular Director of C5 Research at the Cleveland Clinic and Chairman of the VISTA-16 Executive Committee. “We are excited to be continuing our efforts to bring forward this promising therapeutic.”
VISTA-16 is a multinational, randomized, double-blind, placebo-controlled Phase 3 clinical study which will enroll up to 6,500 high-risk ACS patients. Enrollment in VISTA-16 will be stopped after a minimum of 385 primary endpoint events have occurred. High-risk patients are defined as patients who have risk factors that place them at a higher risk of experiencing a secondary coronary event. These risk factors include previous cardiovascular disease, diabetes, or metabolic syndrome. Within 96 hours of experiencing primary ACS, patients are treated with varespladib or placebo once-daily in combination with a physician-prescribed dose of atorvastatin for 16 weeks — the period when patients have the highest risk of experiencing a secondary cardiovascular event. As per a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), the primary endpoint of the VISTA-16 study will be a reduction in major adverse coronary events (MACE), which was defined by recent FDA draft guidance as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization.
About Varespladib and sPLA2
Varespladib is a potent oral inhibitor of the pro-inflammatory enzyme secretory phospholipase A2 (sPLA2). Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including ACS and acute chest syndrome, as well as chronic diseases, such as stable coronary artery disease (CAD). In Anthera’s FRANCIS Phase 2 clinical study in ACS patients, treatment with varespladib improved independent markers of cardiovascular risk including CRP, IL-6, LDL-C and varespladib’s target enzyme, sPLA2. Recent analysis of data from diabetic patients in the same Phase 2 study demonstrated treatment with varespladib was associated with early and statistically significant reductions in these prognostic inflammatory markers of cardiovascular risk. In February 2010, Anthera received an SPA from the U.S. FDA for the VISTA-16 Phase 3 study for the use of varespladib in treating high-risk ACS patients. The next substantial review of clinical safety and efficacy data will be conducted after 50 percent of the anticipated primary endpoints have occurred. At this review the DSMB will conduct the first prescribed statistical efficacy review of the primary endpoint of the VISTA-16 Study. This review is expected to take place in the second half of 2011.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including cardiovascular and autoimmune diseases. Anthera has one Phase 3 clinical program, A-002, and two Phase 2 clinical programs, A-623 and A-001. A-002 and A-001 inhibit a novel enzyme target known as sPLA2. Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including acute coronary syndrome and acute chest syndrome, as well as chronic diseases such as stable coronary artery disease (CAD). Anthera’s Phase 2 product candidate, A-623, targets elevated levels of B-lymphocyte stimulator (BAFF) which has been associated with a variety of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus (lupus). For more information, please visit www.anthera.com.
About C5Research
C5Research, Cleveland Clinic Coordinating Center for Clinical Research, is an academic research organization (ARO), which provides clinical trial services to the pharmaceutical, biotechnology, and medical device industries. C5Research also supports NIH and Cleveland Clinic investigator-initiated clinical research and work with other AROs and contract research organizations to develop, implement, and successfully conduct clinical trials.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, but are not limited to, statements relating to the anticipated initiation of Anthera’s clinical studies, anticipated duration and expected results of these studies, and the progression of Anthera’s products through future stages of clinical development. These forward-looking statements are based on Anthera’s expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in the Company’s public filings with the Securities and Exchange Commission, including Anthera’s Annual Report on Form 10-K for the year ended December 31, 2010. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
CONTACT: Bianca Nery of Anthera Pharmaceuticals, Inc., bnery@anthera.com or 510.856.5586.
SOURCE Anthera Pharmaceuticals, Inc.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.Anthera Pharmaceuticals Successfully Completes Interim Biomarker Analysis of VISTA-16 Study and Third Safety Review of Varespladib Methyl
James Harris Associates mission is to embrace our client’s goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
VISTA-16 Study to Continue Global Enrollment
HAYWARD, Calif., April 18, 2011 /PRNewswire/ — Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced that enrollment in the Phase 3 VISTA-16 study of varespladib in Acute Coronary Syndromes (ACS) will continue based on the positive outcome of an interim biomarker analysis and review of available patient safety data.
An independent statistician completed an analysis of various biomarkers of cardiovascular risk and determined that treatment with once-daily varespladib met the pre-specified criteria for the study to proceed. The analysis required patients on varespladib to demonstrate pre-defined treatment effects versus placebo at relevant time points on a collection of biomarkers including: secretory phospholipase A2 (sPLA2), low density lipoprotein cholesterol (LDL-C), C-reactive protein (CRP), interleukin-6 (IL-6), and a composite responder endpoint defined as patients achieving LDL-C less than 70 mg/dL and CRP below 1.0 mg/L.
In parallel with the biomarker analysis, the VISTA-16 independent Data Safety and Monitoring Board (DSMB) completed a review of the available safety database including all reported adverse events and serious adverse events and recommended the continuation of the VISTA-16 clinical study without modification. This represents the third meeting of DSMB since the start of the study.
“We continue to believe that positive changes in patient biomarkers similar to changes seen in the FRANCIS Phase 2 clinical study will correlate to a reduction in major adverse cardiovascular events in patients treated with varespladib for 16 weeks,” said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals. “We are hopeful this approach will eventually prove that rapid and safe reduction of inflammation following an acute coronary syndrome will translate into better treatment options for this high-risk patient population.”
“VISTA-16 represents an innovative approach based on years of extensive study of the negative effects of inflammation in patients with ACS”, commented Stephen J. Nicholls, M.D., Ph.D., Cardiovascular Director of C5 Research at the Cleveland Clinic and Chairman of the VISTA-16 Executive Committee. “We are excited to be continuing our efforts to bring forward this promising therapeutic.”
VISTA-16 is a multinational, randomized, double-blind, placebo-controlled Phase 3 clinical study which will enroll up to 6,500 high-risk ACS patients. Enrollment in VISTA-16 will be stopped after a minimum of 385 primary endpoint events have occurred. High-risk patients are defined as patients who have risk factors that place them at a higher risk of experiencing a secondary coronary event. These risk factors include previous cardiovascular disease, diabetes, or metabolic syndrome. Within 96 hours of experiencing primary ACS, patients are treated with varespladib or placebo once-daily in combination with a physician-prescribed dose of atorvastatin for 16 weeks — the period when patients have the highest risk of experiencing a secondary cardiovascular event. As per a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), the primary endpoint of the VISTA-16 study will be a reduction in major adverse coronary events (MACE), which was defined by recent FDA draft guidance as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization.
About Varespladib and sPLA2
Varespladib is a potent oral inhibitor of the pro-inflammatory enzyme secretory phospholipase A2 (sPLA2). Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including ACS and acute chest syndrome, as well as chronic diseases, such as stable coronary artery disease (CAD). In Anthera’s FRANCIS Phase 2 clinical study in ACS patients, treatment with varespladib improved independent markers of cardiovascular risk including CRP, IL-6, LDL-C and varespladib’s target enzyme, sPLA2. Recent analysis of data from diabetic patients in the same Phase 2 study demonstrated treatment with varespladib was associated with early and statistically significant reductions in these prognostic inflammatory markers of cardiovascular risk. In February 2010, Anthera received an SPA from the U.S. FDA for the VISTA-16 Phase 3 study for the use of varespladib in treating high-risk ACS patients. The next substantial review of clinical safety and efficacy data will be conducted after 50 percent of the anticipated primary endpoints have occurred. At this review the DSMB will conduct the first prescribed statistical efficacy review of the primary endpoint of the VISTA-16 Study. This review is expected to take place in the second half of 2011.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including cardiovascular and autoimmune diseases. Anthera has one Phase 3 clinical program, A-002, and two Phase 2 clinical programs, A-623 and A-001. A-002 and A-001 inhibit a novel enzyme target known as sPLA2. Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including acute coronary syndrome and acute chest syndrome, as well as chronic diseases such as stable coronary artery disease (CAD). Anthera’s Phase 2 product candidate, A-623, targets elevated levels of B-lymphocyte stimulator (BAFF) which has been associated with a variety of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus (lupus). For more information, please visit www.anthera.com.
About C5Research
C5Research, Cleveland Clinic Coordinating Center for Clinical Research, is an academic research organization (ARO), which provides clinical trial services to the pharmaceutical, biotechnology, and medical device industries. C5Research also supports NIH and Cleveland Clinic investigator-initiated clinical research and work with other AROs and contract research organizations to develop, implement, and successfully conduct clinical trials.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, but are not limited to, statements relating to the anticipated initiation of Anthera’s clinical studies, anticipated duration and expected results of these studies, and the progression of Anthera’s products through future stages of clinical development. These forward-looking statements are based on Anthera’s expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in the Company’s public filings with the Securities and Exchange Commission, including Anthera’s Annual Report on Form 10-K for the year ended December 31, 2010. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
CONTACT: Bianca Nery of Anthera Pharmaceuticals, Inc., bnery@anthera.com or 510.856.5586.
SOURCE Anthera Pharmaceuticals, Inc.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
Anthera Pharmaceuticals Successfully Completes Interim Biomarker Analysis of VISTA-16 Study and Third Safety Review of Varespladib Methyl
James Harris Associates mission is to embrace our client’s goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
VISTA-16 Study to Continue Global Enrollment
HAYWARD, Calif., April 18, 2011 /PRNewswire/ — Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced that enrollment in the Phase 3 VISTA-16 study of varespladib in Acute Coronary Syndromes (ACS) will continue based on the positive outcome of an interim biomarker analysis and review of available patient safety data.
An independent statistician completed an analysis of various biomarkers of cardiovascular risk and determined that treatment with once-daily varespladib met the pre-specified criteria for the study to proceed. The analysis required patients on varespladib to demonstrate pre-defined treatment effects versus placebo at relevant time points on a collection of biomarkers including: secretory phospholipase A2 (sPLA2), low density lipoprotein cholesterol (LDL-C), C-reactive protein (CRP), interleukin-6 (IL-6), and a composite responder endpoint defined as patients achieving LDL-C less than 70 mg/dL and CRP below 1.0 mg/L.
In parallel with the biomarker analysis, the VISTA-16 independent Data Safety and Monitoring Board (DSMB) completed a review of the available safety database including all reported adverse events and serious adverse events and recommended the continuation of the VISTA-16 clinical study without modification. This represents the third meeting of DSMB since the start of the study.
“We continue to believe that positive changes in patient biomarkers similar to changes seen in the FRANCIS Phase 2 clinical study will correlate to a reduction in major adverse cardiovascular events in patients treated with varespladib for 16 weeks,” said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals. “We are hopeful this approach will eventually prove that rapid and safe reduction of inflammation following an acute coronary syndrome will translate into better treatment options for this high-risk patient population.”
“VISTA-16 represents an innovative approach based on years of extensive study of the negative effects of inflammation in patients with ACS”, commented Stephen J. Nicholls, M.D., Ph.D., Cardiovascular Director of C5 Research at the Cleveland Clinic and Chairman of the VISTA-16 Executive Committee. “We are excited to be continuing our efforts to bring forward this promising therapeutic.”
VISTA-16 is a multinational, randomized, double-blind, placebo-controlled Phase 3 clinical study which will enroll up to 6,500 high-risk ACS patients. Enrollment in VISTA-16 will be stopped after a minimum of 385 primary endpoint events have occurred. High-risk patients are defined as patients who have risk factors that place them at a higher risk of experiencing a secondary coronary event. These risk factors include previous cardiovascular disease, diabetes, or metabolic syndrome. Within 96 hours of experiencing primary ACS, patients are treated with varespladib or placebo once-daily in combination with a physician-prescribed dose of atorvastatin for 16 weeks — the period when patients have the highest risk of experiencing a secondary cardiovascular event. As per a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), the primary endpoint of the VISTA-16 study will be a reduction in major adverse coronary events (MACE), which was defined by recent FDA draft guidance as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization.
About Varespladib and sPLA2
Varespladib is a potent oral inhibitor of the pro-inflammatory enzyme secretory phospholipase A2 (sPLA2). Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including ACS and acute chest syndrome, as well as chronic diseases, such as stable coronary artery disease (CAD). In Anthera’s FRANCIS Phase 2 clinical study in ACS patients, treatment with varespladib improved independent markers of cardiovascular risk including CRP, IL-6, LDL-C and varespladib’s target enzyme, sPLA2. Recent analysis of data from diabetic patients in the same Phase 2 study demonstrated treatment with varespladib was associated with early and statistically significant reductions in these prognostic inflammatory markers of cardiovascular risk. In February 2010, Anthera received an SPA from the U.S. FDA for the VISTA-16 Phase 3 study for the use of varespladib in treating high-risk ACS patients. The next substantial review of clinical safety and efficacy data will be conducted after 50 percent of the anticipated primary endpoints have occurred. At this review the DSMB will conduct the first prescribed statistical efficacy review of the primary endpoint of the VISTA-16 Study. This review is expected to take place in the second half of 2011.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including cardiovascular and autoimmune diseases. Anthera has one Phase 3 clinical program, A-002, and two Phase 2 clinical programs, A-623 and A-001. A-002 and A-001 inhibit a novel enzyme target known as sPLA2. Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including acute coronary syndrome and acute chest syndrome, as well as chronic diseases such as stable coronary artery disease (CAD). Anthera’s Phase 2 product candidate, A-623, targets elevated levels of B-lymphocyte stimulator (BAFF) which has been associated with a variety of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus (lupus). For more information, please visit www.anthera.com.
About C5Research
C5Research, Cleveland Clinic Coordinating Center for Clinical Research, is an academic research organization (ARO), which provides clinical trial services to the pharmaceutical, biotechnology, and medical device industries. C5Research also supports NIH and Cleveland Clinic investigator-initiated clinical research and work with other AROs and contract research organizations to develop, implement, and successfully conduct clinical trials.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, but are not limited to, statements relating to the anticipated initiation of Anthera’s clinical studies, anticipated duration and expected results of these studies, and the progression of Anthera’s products through future stages of clinical development. These forward-looking statements are based on Anthera’s expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in the Company’s public filings with the Securities and Exchange Commission, including Anthera’s Annual Report on Form 10-K for the year ended December 31, 2010. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
CONTACT: Bianca Nery of Anthera Pharmaceuticals, Inc., bnery@anthera.com or 510.856.5586.
SOURCE Anthera Pharmaceuticals, Inc.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.Anthera Pharmaceuticals Successfully Completes Interim Biomarker Analysis of VISTA-16 Study and Third Safety Review of Varespladib Methyl
James Harris Associates mission is to embrace our client’s goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
VISTA-16 Study to Continue Global Enrollment
HAYWARD, Calif., April 18, 2011 /PRNewswire/ — Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced that enrollment in the Phase 3 VISTA-16 study of varespladib in Acute Coronary Syndromes (ACS) will continue based on the positive outcome of an interim biomarker analysis and review of available patient safety data.
An independent statistician completed an analysis of various biomarkers of cardiovascular risk and determined that treatment with once-daily varespladib met the pre-specified criteria for the study to proceed. The analysis required patients on varespladib to demonstrate pre-defined treatment effects versus placebo at relevant time points on a collection of biomarkers including: secretory phospholipase A2 (sPLA2), low density lipoprotein cholesterol (LDL-C), C-reactive protein (CRP), interleukin-6 (IL-6), and a composite responder endpoint defined as patients achieving LDL-C less than 70 mg/dL and CRP below 1.0 mg/L.
In parallel with the biomarker analysis, the VISTA-16 independent Data Safety and Monitoring Board (DSMB) completed a review of the available safety database including all reported adverse events and serious adverse events and recommended the continuation of the VISTA-16 clinical study without modification. This represents the third meeting of DSMB since the start of the study.
“We continue to believe that positive changes in patient biomarkers similar to changes seen in the FRANCIS Phase 2 clinical study will correlate to a reduction in major adverse cardiovascular events in patients treated with varespladib for 16 weeks,” said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals. “We are hopeful this approach will eventually prove that rapid and safe reduction of inflammation following an acute coronary syndrome will translate into better treatment options for this high-risk patient population.”
“VISTA-16 represents an innovative approach based on years of extensive study of the negative effects of inflammation in patients with ACS”, commented Stephen J. Nicholls, M.D., Ph.D., Cardiovascular Director of C5 Research at the Cleveland Clinic and Chairman of the VISTA-16 Executive Committee. “We are excited to be continuing our efforts to bring forward this promising therapeutic.”
VISTA-16 is a multinational, randomized, double-blind, placebo-controlled Phase 3 clinical study which will enroll up to 6,500 high-risk ACS patients. Enrollment in VISTA-16 will be stopped after a minimum of 385 primary endpoint events have occurred. High-risk patients are defined as patients who have risk factors that place them at a higher risk of experiencing a secondary coronary event. These risk factors include previous cardiovascular disease, diabetes, or metabolic syndrome. Within 96 hours of experiencing primary ACS, patients are treated with varespladib or placebo once-daily in combination with a physician-prescribed dose of atorvastatin for 16 weeks — the period when patients have the highest risk of experiencing a secondary cardiovascular event. As per a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), the primary endpoint of the VISTA-16 study will be a reduction in major adverse coronary events (MACE), which was defined by recent FDA draft guidance as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization.
About Varespladib and sPLA2
Varespladib is a potent oral inhibitor of the pro-inflammatory enzyme secretory phospholipase A2 (sPLA2). Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including ACS and acute chest syndrome, as well as chronic diseases, such as stable coronary artery disease (CAD). In Anthera’s FRANCIS Phase 2 clinical study in ACS patients, treatment with varespladib improved independent markers of cardiovascular risk including CRP, IL-6, LDL-C and varespladib’s target enzyme, sPLA2. Recent analysis of data from diabetic patients in the same Phase 2 study demonstrated treatment with varespladib was associated with early and statistically significant reductions in these prognostic inflammatory markers of cardiovascular risk. In February 2010, Anthera received an SPA from the U.S. FDA for the VISTA-16 Phase 3 study for the use of varespladib in treating high-risk ACS patients. The next substantial review of clinical safety and efficacy data will be conducted after 50 percent of the anticipated primary endpoints have occurred. At this review the DSMB will conduct the first prescribed statistical efficacy review of the primary endpoint of the VISTA-16 Study. This review is expected to take place in the second half of 2011.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including cardiovascular and autoimmune diseases. Anthera has one Phase 3 clinical program, A-002, and two Phase 2 clinical programs, A-623 and A-001. A-002 and A-001 inhibit a novel enzyme target known as sPLA2. Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including acute coronary syndrome and acute chest syndrome, as well as chronic diseases such as stable coronary artery disease (CAD). Anthera’s Phase 2 product candidate, A-623, targets elevated levels of B-lymphocyte stimulator (BAFF) which has been associated with a variety of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus (lupus). For more information, please visit www.anthera.com.
About C5Research
C5Research, Cleveland Clinic Coordinating Center for Clinical Research, is an academic research organization (ARO), which provides clinical trial services to the pharmaceutical, biotechnology, and medical device industries. C5Research also supports NIH and Cleveland Clinic investigator-initiated clinical research and work with other AROs and contract research organizations to develop, implement, and successfully conduct clinical trials.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, but are not limited to, statements relating to the anticipated initiation of Anthera’s clinical studies, anticipated duration and expected results of these studies, and the progression of Anthera’s products through future stages of clinical development. These forward-looking statements are based on Anthera’s expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in the Company’s public filings with the Securities and Exchange Commission, including Anthera’s Annual Report on Form 10-K for the year ended December 31, 2010. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
CONTACT: Bianca Nery of Anthera Pharmaceuticals, Inc., bnery@anthera.com or 510.856.5586.
SOURCE Anthera Pharmaceuticals, Inc.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
Harris James Associates Update: Congressional forum on biotech jobs focuses on FDA By Keith Darcé
http://www.your-story.org/harris-james-associates-update-congressional-forum-on-biotech-jobs-focuses-on-fda-by-keith-darce-239626/Harris James Associates Update: Overly cautious government regulators, threats to basic science research funding and burdensome taxes are holding back job creation by drug and medical device companies and slowing the delivery of innovative new therapies to patients, biotechnology industry experts told federal lawmakers Thursday during a hearing in San Diego.
James Harris Associates mission is to embrace our client’s goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
Most of the criticism was directed at the Food and Drug Administration, which approved 21 new drugs last year, compared to 36 in 2004.
“There are whole areas (of drug development) that venture capitalists won’t pursue because the regulatory barriers are too high,” said David Gollaher, president and chief executive of the California Healthcare Institute in La Jolla.
The complaints were familiar to anyone who has followed drug and medical device development in the United States over the past several years.
Gollaher and the other experts delivered their comments to Rep. Darrell Issa, R-Vista, during a morning public forum at the University of California San Diego. Since he became chairman of the House Oversight and Government Reform Committee in early January, Issa has hosted 10 such gatherings around the country focused on regulations that stifle economic expansion.
For the latest gathering, he returned to his home county, where more than 400 companies make up a major biotechnology hub that employs more than 40,000 people, according to the San Diego trade group Biocom.
Issa was joined by Reps. Susan Davis, D-San Diego; Brian Bilbray, R-Solana Beach; and Duncan Hunter, R-Alpine.
Issa’s committee has broad investigative power, but any legislation addressing specific regulatory changes would be handled by other congressional panels that directly oversee the related agencies.
“We’re here today because San Diego is a miraculous story of biotech,” Issa said in comments that opened the 1½-hour session.
To aid his investigation, Issa solicited comments from hundreds of individuals, companies and trade groups, including many in the biotechnology and pharmaceutical industries, both directly and through a special website, americanjobcreators.com.
“We were shocked to find out that the FDA is often one of the greatest impediments to job creation,” the congressman said.
Critics of the agency say the problem is most clearly displayed in the increasing amount of time that it takes the agency to process new product applications.
Since 2007, drug review times by the FDA have increased by 28 percent, while evaluations of devices have taken as much as 75 percent more time, Gollaher said.
They also point to a recent string of unexpected new drug rejections by the agency that forced developers to perform new tests on their experimental medications.
Just in the past six months, the FDA turned down three drugs from San Diego companies: diet pills from Arena Pharmaceuticals and Orexigen Therapeutics, and a weekly injectable diabetes therapy from Amylin.
In a recent survey by Biocom, industry executives said the agency’s review process lacks transparency, often becomes sidetracked by unexpected issues and takes too much time.
“We see a growing concern that the FDA is becoming detached from the industry,” said Joe Panetta, president and chief executive of Biocom.
Many of the problems can be blamed on a cultural change at the agency that raised the emphasis on potential risks that new drugs and devices pose in the wake of a long string of high-profile medical product recalls, Gollaher said.
Still, some people say the changes have been good. Public Citizen and other consumer advocacy groups have praised the FDA for scrutinizing new medical products more intensely and requiring more safety testing before allowing them onto the market.
One possible way of shifting the agency’s focus more toward the potential benefits of new products is to give a formal role in the regulatory review process to the patients who would use the drugs and devices, said Duane Roth, chief executive of Connect San Diego, a nonprofit support group for fledgling technology companies.
“It’s their disease,” he said. “It’s not yours, and it’s not ours. Until they get in there to help us, I don’t think much will change.”
UCSD Chancellor Marye Anne Fox implored the lawmakers to resist urges to cut basic science grant funding from the National Institutes of Health, which sent $824 million to her university and other scientific institutes in the county last year.
The money produces many of the discoveries that are later taken up by biotechnology companies and turned into products.
keith.darce@uniontrib.com (619) 293-1020
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
James Harris Associates mission is to embrace our client’s goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
Most of the criticism was directed at the Food and Drug Administration, which approved 21 new drugs last year, compared to 36 in 2004.
“There are whole areas (of drug development) that venture capitalists won’t pursue because the regulatory barriers are too high,” said David Gollaher, president and chief executive of the California Healthcare Institute in La Jolla.
The complaints were familiar to anyone who has followed drug and medical device development in the United States over the past several years.
Gollaher and the other experts delivered their comments to Rep. Darrell Issa, R-Vista, during a morning public forum at the University of California San Diego. Since he became chairman of the House Oversight and Government Reform Committee in early January, Issa has hosted 10 such gatherings around the country focused on regulations that stifle economic expansion.
For the latest gathering, he returned to his home county, where more than 400 companies make up a major biotechnology hub that employs more than 40,000 people, according to the San Diego trade group Biocom.
Issa was joined by Reps. Susan Davis, D-San Diego; Brian Bilbray, R-Solana Beach; and Duncan Hunter, R-Alpine.
Issa’s committee has broad investigative power, but any legislation addressing specific regulatory changes would be handled by other congressional panels that directly oversee the related agencies.
“We’re here today because San Diego is a miraculous story of biotech,” Issa said in comments that opened the 1½-hour session.
To aid his investigation, Issa solicited comments from hundreds of individuals, companies and trade groups, including many in the biotechnology and pharmaceutical industries, both directly and through a special website, americanjobcreators.com.
“We were shocked to find out that the FDA is often one of the greatest impediments to job creation,” the congressman said.
Critics of the agency say the problem is most clearly displayed in the increasing amount of time that it takes the agency to process new product applications.
Since 2007, drug review times by the FDA have increased by 28 percent, while evaluations of devices have taken as much as 75 percent more time, Gollaher said.
They also point to a recent string of unexpected new drug rejections by the agency that forced developers to perform new tests on their experimental medications.
Just in the past six months, the FDA turned down three drugs from San Diego companies: diet pills from Arena Pharmaceuticals and Orexigen Therapeutics, and a weekly injectable diabetes therapy from Amylin.
In a recent survey by Biocom, industry executives said the agency’s review process lacks transparency, often becomes sidetracked by unexpected issues and takes too much time.
“We see a growing concern that the FDA is becoming detached from the industry,” said Joe Panetta, president and chief executive of Biocom.
Many of the problems can be blamed on a cultural change at the agency that raised the emphasis on potential risks that new drugs and devices pose in the wake of a long string of high-profile medical product recalls, Gollaher said.
Still, some people say the changes have been good. Public Citizen and other consumer advocacy groups have praised the FDA for scrutinizing new medical products more intensely and requiring more safety testing before allowing them onto the market.
One possible way of shifting the agency’s focus more toward the potential benefits of new products is to give a formal role in the regulatory review process to the patients who would use the drugs and devices, said Duane Roth, chief executive of Connect San Diego, a nonprofit support group for fledgling technology companies.
“It’s their disease,” he said. “It’s not yours, and it’s not ours. Until they get in there to help us, I don’t think much will change.”
UCSD Chancellor Marye Anne Fox implored the lawmakers to resist urges to cut basic science grant funding from the National Institutes of Health, which sent $824 million to her university and other scientific institutes in the county last year.
The money produces many of the discoveries that are later taken up by biotechnology companies and turned into products.
keith.darce@uniontrib.com (619) 293-1020
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
Harris James Associates: Anthera Pharmaceuticals Successfully Completes Interim
http://www.onlineprnews.com/news/128011-1303278145-harris-james-associates-anthera-pharmaceuticals-successfully-completes-interim.htmlOnline PR News – 21-April-2011 –Anthera Pharmaceuticals Successfully Completes Interim Biomarker Analysis of VISTA-16 Study and Third Safety Review of Varespladib Methyl
James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
VISTA-16 Study to Continue Global Enrollment
HAYWARD, Calif., April 18, 2011 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced that enrollment in the Phase 3 VISTA-16 study of varespladib in Acute Coronary Syndromes (ACS) will continue based on the positive outcome of an interim biomarker analysis and review of available patient safety data.
An independent statistician completed an analysis of various biomarkers of cardiovascular risk and determined that treatment with once-daily varespladib met the pre-specified criteria for the study to proceed. The analysis required patients on varespladib to demonstrate pre-defined treatment effects versus placebo at relevant time points on a collection of biomarkers including: secretory phospholipase A2 (sPLA2), low density lipoprotein cholesterol (LDL-C), C-reactive protein (CRP), interleukin-6 (IL-6), and a composite responder endpoint defined as patients achieving LDL-C less than 70 mg/dL and CRP below 1.0 mg/L.
In parallel with the biomarker analysis, the VISTA-16 independent Data Safety and Monitoring Board (DSMB) completed a review of the available safety database including all reported adverse events and serious adverse events and recommended the continuation of the VISTA-16 clinical study without modification. This represents the third meeting of DSMB since the start of the study.
"We continue to believe that positive changes in patient biomarkers similar to changes seen in the FRANCIS Phase 2 clinical study will correlate to a reduction in major adverse cardiovascular events in patients treated with varespladib for 16 weeks," said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals. "We are hopeful this approach will eventually prove that rapid and safe reduction of inflammation following an acute coronary syndrome will translate into better treatment options for this high-risk patient population."
"VISTA-16 represents an innovative approach based on years of extensive study of the negative effects of inflammation in patients with ACS", commented Stephen J. Nicholls, M.D., Ph.D., Cardiovascular Director of C5 Research at the Cleveland Clinic and Chairman of the VISTA-16 Executive Committee. "We are excited to be continuing our efforts to bring forward this promising therapeutic."
VISTA-16 is a multinational, randomized, double-blind, placebo-controlled Phase 3 clinical study which will enroll up to 6,500 high-risk ACS patients. Enrollment in VISTA-16 will be stopped after a minimum of 385 primary endpoint events have occurred. High-risk patients are defined as patients who have risk factors that place them at a higher risk of experiencing a secondary coronary event. These risk factors include previous cardiovascular disease, diabetes, or metabolic syndrome. Within 96 hours of experiencing primary ACS, patients are treated with varespladib or placebo once-daily in combination with a physician-prescribed dose of atorvastatin for 16 weeks — the period when patients have the highest risk of experiencing a secondary cardiovascular event. As per a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), the primary endpoint of the VISTA-16 study will be a reduction in major adverse coronary events (MACE), which was defined by recent FDA draft guidance as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization.
About Varespladib and sPLA2
Varespladib is a potent oral inhibitor of the pro-inflammatory enzyme secretory phospholipase A2 (sPLA2). Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including ACS and acute chest syndrome, as well as chronic diseases, such as stable coronary artery disease (CAD). In Anthera's FRANCIS Phase 2 clinical study in ACS patients, treatment with varespladib improved independent markers of cardiovascular risk including CRP, IL-6, LDL-C and varespladib's target enzyme, sPLA2. Recent analysis of data from diabetic patients in the same Phase 2 study demonstrated treatment with varespladib was associated with early and statistically significant reductions in these prognostic inflammatory markers of cardiovascular risk. In February 2010, Anthera received an SPA from the U.S. FDA for the VISTA-16 Phase 3 study for the use of varespladib in treating high-risk ACS patients. The next substantial review of clinical safety and efficacy data will be conducted after 50 percent of the anticipated primary endpoints have occurred. At this review the DSMB will conduct the first prescribed statistical efficacy review of the primary endpoint of the VISTA-16 Study. This review is expected to take place in the second half of 2011.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including cardiovascular and autoimmune diseases. Anthera has one Phase 3 clinical program, A-002, and two Phase 2 clinical programs, A-623 and A-001. A-002 and A-001 inhibit a novel enzyme target known as sPLA2. Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including acute coronary syndrome and acute chest syndrome, as well as chronic diseases such as stable coronary artery disease (CAD). Anthera's Phase 2 product candidate, A-623, targets elevated levels of B-lymphocyte stimulator (BAFF) which has been associated with a variety of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus (lupus). For more information, please visit www.anthera.com.
About C5Research
C5Research, Cleveland Clinic Coordinating Center for Clinical Research, is an academic research organization (ARO), which provides clinical trial services to the pharmaceutical, biotechnology, and medical device industries. C5Research also supports NIH and Cleveland Clinic investigator-initiated clinical research and work with other AROs and contract research organizations to develop, implement, and successfully conduct clinical trials.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, but are not limited to, statements relating to the anticipated initiation of Anthera's clinical studies, anticipated duration and expected results of these studies, and the progression of Anthera's products through future stages of clinical development. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in the Company's public filings with the Securities and Exchange Commission, including Anthera's Annual Report on Form 10-K for the year ended December 31, 2010. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
CONTACT: Bianca Nery of Anthera Pharmaceuticals, Inc., bnery@anthera.com or 510.856.5586.
SOURCE Anthera Pharmaceuticals, Inc.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
VISTA-16 Study to Continue Global Enrollment
HAYWARD, Calif., April 18, 2011 /PRNewswire/ -- Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH), a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation, today announced that enrollment in the Phase 3 VISTA-16 study of varespladib in Acute Coronary Syndromes (ACS) will continue based on the positive outcome of an interim biomarker analysis and review of available patient safety data.
An independent statistician completed an analysis of various biomarkers of cardiovascular risk and determined that treatment with once-daily varespladib met the pre-specified criteria for the study to proceed. The analysis required patients on varespladib to demonstrate pre-defined treatment effects versus placebo at relevant time points on a collection of biomarkers including: secretory phospholipase A2 (sPLA2), low density lipoprotein cholesterol (LDL-C), C-reactive protein (CRP), interleukin-6 (IL-6), and a composite responder endpoint defined as patients achieving LDL-C less than 70 mg/dL and CRP below 1.0 mg/L.
In parallel with the biomarker analysis, the VISTA-16 independent Data Safety and Monitoring Board (DSMB) completed a review of the available safety database including all reported adverse events and serious adverse events and recommended the continuation of the VISTA-16 clinical study without modification. This represents the third meeting of DSMB since the start of the study.
"We continue to believe that positive changes in patient biomarkers similar to changes seen in the FRANCIS Phase 2 clinical study will correlate to a reduction in major adverse cardiovascular events in patients treated with varespladib for 16 weeks," said Paul F. Truex, President and Chief Executive Officer of Anthera Pharmaceuticals. "We are hopeful this approach will eventually prove that rapid and safe reduction of inflammation following an acute coronary syndrome will translate into better treatment options for this high-risk patient population."
"VISTA-16 represents an innovative approach based on years of extensive study of the negative effects of inflammation in patients with ACS", commented Stephen J. Nicholls, M.D., Ph.D., Cardiovascular Director of C5 Research at the Cleveland Clinic and Chairman of the VISTA-16 Executive Committee. "We are excited to be continuing our efforts to bring forward this promising therapeutic."
VISTA-16 is a multinational, randomized, double-blind, placebo-controlled Phase 3 clinical study which will enroll up to 6,500 high-risk ACS patients. Enrollment in VISTA-16 will be stopped after a minimum of 385 primary endpoint events have occurred. High-risk patients are defined as patients who have risk factors that place them at a higher risk of experiencing a secondary coronary event. These risk factors include previous cardiovascular disease, diabetes, or metabolic syndrome. Within 96 hours of experiencing primary ACS, patients are treated with varespladib or placebo once-daily in combination with a physician-prescribed dose of atorvastatin for 16 weeks — the period when patients have the highest risk of experiencing a secondary cardiovascular event. As per a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), the primary endpoint of the VISTA-16 study will be a reduction in major adverse coronary events (MACE), which was defined by recent FDA draft guidance as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or documented unstable angina with objective evidence of ischemia requiring hospitalization.
About Varespladib and sPLA2
Varespladib is a potent oral inhibitor of the pro-inflammatory enzyme secretory phospholipase A2 (sPLA2). Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including ACS and acute chest syndrome, as well as chronic diseases, such as stable coronary artery disease (CAD). In Anthera's FRANCIS Phase 2 clinical study in ACS patients, treatment with varespladib improved independent markers of cardiovascular risk including CRP, IL-6, LDL-C and varespladib's target enzyme, sPLA2. Recent analysis of data from diabetic patients in the same Phase 2 study demonstrated treatment with varespladib was associated with early and statistically significant reductions in these prognostic inflammatory markers of cardiovascular risk. In February 2010, Anthera received an SPA from the U.S. FDA for the VISTA-16 Phase 3 study for the use of varespladib in treating high-risk ACS patients. The next substantial review of clinical safety and efficacy data will be conducted after 50 percent of the anticipated primary endpoints have occurred. At this review the DSMB will conduct the first prescribed statistical efficacy review of the primary endpoint of the VISTA-16 Study. This review is expected to take place in the second half of 2011.
About Anthera Pharmaceuticals
Anthera Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products to treat serious diseases associated with inflammation, including cardiovascular and autoimmune diseases. Anthera has one Phase 3 clinical program, A-002, and two Phase 2 clinical programs, A-623 and A-001. A-002 and A-001 inhibit a novel enzyme target known as sPLA2. Elevated levels of sPLA2 have been implicated in a variety of acute inflammatory conditions, including acute coronary syndrome and acute chest syndrome, as well as chronic diseases such as stable coronary artery disease (CAD). Anthera's Phase 2 product candidate, A-623, targets elevated levels of B-lymphocyte stimulator (BAFF) which has been associated with a variety of B-Cell mediated autoimmune diseases, including systemic lupus erythematosus (lupus). For more information, please visit www.anthera.com.
About C5Research
C5Research, Cleveland Clinic Coordinating Center for Clinical Research, is an academic research organization (ARO), which provides clinical trial services to the pharmaceutical, biotechnology, and medical device industries. C5Research also supports NIH and Cleveland Clinic investigator-initiated clinical research and work with other AROs and contract research organizations to develop, implement, and successfully conduct clinical trials.
Safe Harbor Statement
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, but are not limited to, statements relating to the anticipated initiation of Anthera's clinical studies, anticipated duration and expected results of these studies, and the progression of Anthera's products through future stages of clinical development. These forward-looking statements are based on Anthera's expectations as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially as set forth in the Company's public filings with the Securities and Exchange Commission, including Anthera's Annual Report on Form 10-K for the year ended December 31, 2010. Anthera disclaims any intent or obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.
CONTACT: Bianca Nery of Anthera Pharmaceuticals, Inc., bnery@anthera.com or 510.856.5586.
SOURCE Anthera Pharmaceuticals, Inc.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
Harris James Associates Biomedicine News: Can Hobbyists and Hackers Transform Biotechnology?
www.openpr.com/news/172549/Harris-James-Associates-Biomedicine-News-Can-Hobbyists-and-Hackers-Transform-Biotechnology.html(openPR) - James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
DIY Scientists Hack the Software of Life, Marcus Wohlsen explores the new movement in garage-based biotech. By Amanda Gefter.
Biohackers are on a mission to change all that. These do-it-yourself biology hobbyists want to bring biotechnology out of institutional labs and into our homes. Following in the footsteps of revolutionaries like Steve Jobs and Steve Wozniak, who built the first Apple computer in Jobs's garage, and Sergey Brin and Larry Page, who invented Google in a friend's garage, biohackers are attempting bold feats of genetic engineering, drug development, and biotech research in makeshift home laboratories.
In Biopunk, journalist Marcus Wohlsen surveys the rising tide of the biohacker movement, which has been made possible by a convergence of better and cheaper technologies. For a few hundred dollars, anyone can send some spit to a sequencing company and receive a complete DNA scan, and then use free software to analyze the results. Custom-made DNA can be mail-ordered off websites, and affordable biotech gear is available on Craigslist and eBay.
Wohlson discovers that biohackers, like the open-source programmers and software hackers who came before, are united by a profound idealism. They believe in the power of individuals as opposed to corporate interests, in the wisdom of crowds as opposed to the single-mindedness of experts, and in the incentive to do good for the world as opposed to the need to turn a profit. Suspicious of scientific elitism and inspired by the success of open-source computing, the bio DIYers believe that individuals have a fundamental right to biological information, that spreading the tools of biotech to the masses will accelerate the pace of progress, and that the fruits of the biosciences should be delivered into the hands of the people who need them the most.
With all their ingenuity and idealism, it's difficult not to root for the biohackers Wohlsen meets. Take MIT grad student Kay Aull, who built her own genetic testing kit in her closet after her father was diagnosed with the hereditary disease hemochromatosis. "Aull's test does not represent new science but a new way of doing science," Wohlsen writes. Aull's self-test for the disease-causing mutation came back positive.
Or take Meredith Patterson, who is trying to create a cheap, decentralized way to test milk for melamine poisoning without relying on government regulators. Patterson has written a "Biopunk Manifesto" that reads in part, "Scientific literacy empowers everyone who possesses it to be active contributors to their own health care, the quality of their food, water and air, their very interactions with their own bodies and the complex world around them."
3814 Northampton Road,
Durham, North Carolina 27707-5082
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DIY Scientists Hack the Software of Life, Marcus Wohlsen explores the new movement in garage-based biotech. By Amanda Gefter.
For most of us, managing our health means visiting a doctor. The more serious our concerns, the more specialized a medical expert we seek. Our bodies often feel like foreign and frightening lands, and we are happy to let someone with an MD serve as our tour guide. For most of us, our own DNA never makes it onto our personal reading list.
Biohackers are on a mission to change all that. These do-it-yourself biology hobbyists want to bring biotechnology out of institutional labs and into our homes. Following in the footsteps of revolutionaries like Steve Jobs and Steve Wozniak, who built the first Apple computer in Jobs's garage, and Sergey Brin and Larry Page, who invented Google in a friend's garage, biohackers are attempting bold feats of genetic engineering, drug development, and biotech research in makeshift home laboratories.
In Biopunk, journalist Marcus Wohlsen surveys the rising tide of the biohacker movement, which has been made possible by a convergence of better and cheaper technologies. For a few hundred dollars, anyone can send some spit to a sequencing company and receive a complete DNA scan, and then use free software to analyze the results. Custom-made DNA can be mail-ordered off websites, and affordable biotech gear is available on Craigslist and eBay.
Wohlson discovers that biohackers, like the open-source programmers and software hackers who came before, are united by a profound idealism. They believe in the power of individuals as opposed to corporate interests, in the wisdom of crowds as opposed to the single-mindedness of experts, and in the incentive to do good for the world as opposed to the need to turn a profit. Suspicious of scientific elitism and inspired by the success of open-source computing, the bio DIYers believe that individuals have a fundamental right to biological information, that spreading the tools of biotech to the masses will accelerate the pace of progress, and that the fruits of the biosciences should be delivered into the hands of the people who need them the most.
With all their ingenuity and idealism, it's difficult not to root for the biohackers Wohlsen meets. Take MIT grad student Kay Aull, who built her own genetic testing kit in her closet after her father was diagnosed with the hereditary disease hemochromatosis. "Aull's test does not represent new science but a new way of doing science," Wohlsen writes. Aull's self-test for the disease-causing mutation came back positive.
Or take Meredith Patterson, who is trying to create a cheap, decentralized way to test milk for melamine poisoning without relying on government regulators. Patterson has written a "Biopunk Manifesto" that reads in part, "Scientific literacy empowers everyone who possesses it to be active contributors to their own health care, the quality of their food, water and air, their very interactions with their own bodies and the complex world around them."
Biohackers Josh Perfetto and Tito Jankowski created OpenPCR, a cheap, hackable DNA Xerox machine (PCR stands for "polymerase chain reaction," the name for a method of replicating DNA). Interested biohackers can pre-order one for just over $500 or, once it's ready, download the blueprint free and make their own. According to the website, its apps include DNA sequencing and a test to "check that sushi is legit." Jankowski "hopes to introduce young people to the tools and techniques of biotech in a way that makes gene tweaking as much a part of everyday technology as texting," Wohlsen writes. Jankowski, together with Joseph Jackson and Eri Gentry, also founded BioCurious, a collaborative lab space for biohackers in the Bay area. "Got an idea for a startup? Join the DIY, 'garage biology' movement and found a new breed of biotech," their website exhorts.
James Harris Associates is devoted to providing operational, technological, and regulatory services to the Pharmaceutical and Biotechnology industries. Our confidential services are provided in manufacturing, quality, engineering, materials management and logistics, regulatory, and training. We routinely serve clients in the United States, Europe and Asia. Skilled consultants assist in facility or process upgradesm validation, start-up, new facility design, location services, FDA liaison, and product registration.
James Harris Associates mission is to embrace our client's goals as our own and to work as an extension of the client organization to reach our common objective. We know that we will be successful only if we make our clients more successful.
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Harris James Associates : Portfolio Balancing
http://www.harrisjamesassociates.com/portfoliobalancing.html
Portfolio Balancing
Rebalancing a person's investment decision profile can become a vital need due to private lifestyle adjustments for instance age, earnings, pension, inheritances, or even purchase or sale of a property or another significant property such as property, brand new assets requirements, as well as an modification in private associated risk threshold, and so on. As well, rebalancing is often required as a result of changes in asset allocation due to altered investment expectations, or to realign portfolio weightings in line with target allocations due to changing values of individual portfolio holdings. As part of the HJA commitment to excellence, and our focus on unparalleled client service, your HJA Account Executive will routinely monitor, and provide assistance when portfolio rebalancing is advised.Timely Advice
Whether one is a seasoned investor or a newcomer to the world of private investing, your HJA representative is prepared to assist in any way practical. Advice regarding any or all aspects of your personal investment program, its overall wealth building strategy and tactical recommendations in light of changing market circumstances is yours for the asking. When Harris James Associates research discovers a compelling stock investment that meets with your overall objectives, you will be advised in a timely manner so that you may consider it for your portfolio without undue delay. Or when changing circumstances suggest a liquidation of a given investment, and because you are the ultimate decision maker, we will advise you of such changes with all practical haste.Harris James Associates for New Investors: The Basics of IPO
http://www.sbwire.com/press-releases/sbwire-85953.htmNew York City, NY -- (SBWIRE) -- 04/04/2011 -- Harris James Associates, New York is one of the market leader in Financial Services. The following serves as a guide to Initial Public Offering (IPOs) made to eliminate the fear (and simplify the jargon) that IPO’s are more risky than ordinary investments.
At HJA New York, we offer our clients with the most recent and widest choices of financial products and services. These days, we know that choosing the right investment, the right product and the right strategy is not a walk in the park. So whether it concerns investments, financial planning or advice, we are here to answer all your questions and assist in your financial needs.
Harris James Associates ensures that our clients possess the best info on which to base intelligent business and financial decisions in pursuit of superior investment performance. In order to achieve and maintain that standard of information and timely advice, management and staff are committed to a level of excellence in research, market intelligence, trade executions, and client service that is both demanding and rewarding. We judge our success in maintaining that high level of excellence by the one true measurement; the satisfaction and investment performance of our growing clientele. At Harris James Associates, the Client's success is our primary objective. Investment success in these volatile times can be fleeting for many, which is why our commitment to excellence in everything we do will be a constant regardless of the often turbulent world around us.
Harris James Associates will also seek to provide expertise to investee companies not commonly available from institutional investors. In return, HJA expects to earn strategic investment grade entry prices by creating or securing investment opportunities that might not otherwise be available.
Making a private company public is done through an Initial Public Offering (IPO). This phase is definitely one of the most crucial moments in a company’s timeline. The company issues a certain number of share certificates at a fixed price. Each share can be bought or sold on the stock market where the company is listed, and each stockholder in turn becomes part owner of the company.
It’s a particularly complex process with a maze of compliance and regulatory requirements. But the financial benefits are just as great. A well-subscribed and successful IPO can turn a small company into an international corporate heavyweight at once.
The greatest advantage of a public offering is undeniably the massive capital infusion to fund the ongoing operations and planned expansion of the company. It can reduce the company’s debt and significantly improves its liquidity position. Also, there’s a big uptick in brand recognition and trust in the company’s services and products.
First, a prospectus for the IPO and a registration statement are filed with the SEC. It details everything an investor would like to know about the company and its plans in the future. This is where the underwriters come into the picture.
Underwriters not only assist with the filing requirements but also alter the company’s structure, meaning, they help in the transition of the company into a private enterprise into a public one (with stockholders and a Board). However, their primary job is to aid in deciding on the specifics of the IPO like the number of shares, the pricing and the market.
When the public offering pass, the company has specific new responsibilities that include making public the quarterly financial results, filing statements with the SEC for anything major the affects the company and its operations, and the AGM. At a stockholders’ meeting, essential concerns are discussed and voted upon, including the composition of top-level management and the Board. This is why after an IPO, most companies hire new managers: to deal with certain issues of public companies.
The success of an IPO primarily depends on the growth potential of the company and the sector where it belongs, and if the business has fine basics and revenue model. However, many IPO’s failed despite of having all that. Maybe, it is because they did not select the right price or the right market, or simply pick the wrong time to go public.
Take Canada for example, where an IPO won’t be able to get to the price or size that an offering in the US markets can fetch. The market in Canada has a lower risk threshold. And in Europe, there are more concerns that need to be addressed, such as the condition of the economy in each member’s state of the EU that affect every market in Europe.
Back when dotcoms were still in trend, practically anyone with a website could file for an IPO, and watch the millions pile up as the markets steadily rise. But now, what investors want is a safe company with long term growth prospects and lots of assets to its name. For any business that can pass through this long road to IPO success, there’s a great prize on the other end.
At HJA New York, we offer our clients with the most recent and widest choices of financial products and services. These days, we know that choosing the right investment, the right product and the right strategy is not a walk in the park. So whether it concerns investments, financial planning or advice, we are here to answer all your questions and assist in your financial needs.
Harris James Associates ensures that our clients possess the best info on which to base intelligent business and financial decisions in pursuit of superior investment performance. In order to achieve and maintain that standard of information and timely advice, management and staff are committed to a level of excellence in research, market intelligence, trade executions, and client service that is both demanding and rewarding. We judge our success in maintaining that high level of excellence by the one true measurement; the satisfaction and investment performance of our growing clientele. At Harris James Associates, the Client's success is our primary objective. Investment success in these volatile times can be fleeting for many, which is why our commitment to excellence in everything we do will be a constant regardless of the often turbulent world around us.
Harris James Associates will also seek to provide expertise to investee companies not commonly available from institutional investors. In return, HJA expects to earn strategic investment grade entry prices by creating or securing investment opportunities that might not otherwise be available.
Making a private company public is done through an Initial Public Offering (IPO). This phase is definitely one of the most crucial moments in a company’s timeline. The company issues a certain number of share certificates at a fixed price. Each share can be bought or sold on the stock market where the company is listed, and each stockholder in turn becomes part owner of the company.
It’s a particularly complex process with a maze of compliance and regulatory requirements. But the financial benefits are just as great. A well-subscribed and successful IPO can turn a small company into an international corporate heavyweight at once.
The greatest advantage of a public offering is undeniably the massive capital infusion to fund the ongoing operations and planned expansion of the company. It can reduce the company’s debt and significantly improves its liquidity position. Also, there’s a big uptick in brand recognition and trust in the company’s services and products.
First, a prospectus for the IPO and a registration statement are filed with the SEC. It details everything an investor would like to know about the company and its plans in the future. This is where the underwriters come into the picture.
Underwriters not only assist with the filing requirements but also alter the company’s structure, meaning, they help in the transition of the company into a private enterprise into a public one (with stockholders and a Board). However, their primary job is to aid in deciding on the specifics of the IPO like the number of shares, the pricing and the market.
When the public offering pass, the company has specific new responsibilities that include making public the quarterly financial results, filing statements with the SEC for anything major the affects the company and its operations, and the AGM. At a stockholders’ meeting, essential concerns are discussed and voted upon, including the composition of top-level management and the Board. This is why after an IPO, most companies hire new managers: to deal with certain issues of public companies.
The success of an IPO primarily depends on the growth potential of the company and the sector where it belongs, and if the business has fine basics and revenue model. However, many IPO’s failed despite of having all that. Maybe, it is because they did not select the right price or the right market, or simply pick the wrong time to go public.
Take Canada for example, where an IPO won’t be able to get to the price or size that an offering in the US markets can fetch. The market in Canada has a lower risk threshold. And in Europe, there are more concerns that need to be addressed, such as the condition of the economy in each member’s state of the EU that affect every market in Europe.
Back when dotcoms were still in trend, practically anyone with a website could file for an IPO, and watch the millions pile up as the markets steadily rise. But now, what investors want is a safe company with long term growth prospects and lots of assets to its name. For any business that can pass through this long road to IPO success, there’s a great prize on the other end.
Harris James Associates Socially Accountable Investing
http://www.sbwire.com/press-releases/sbwire-88655.htmWhat is socially accountable investing?
RI tactics supply investors using the opportunity to produce beneficial modify on the planet by their personal decisions whilst remaining concentrated on their long-term investment strategy.
Final results might be favorable
Implementing social awareness in different ways
Mutual funds vs. individual investing
Themes arise with the times
Investing in your priorities
The most effective tactic to socially responsible investing is to make sure that the execution from the system is consistent with your general economic plan. Your monetary advisor can assistance you review your current asset allocation and enable you consider whether social investing is correct for you.
Socially accountable investing (SRI) describes an investment strategy that brings together the intentions to increase both equally fiscal return and social excellent. Generally, socially responsible traders favor company practices that happen to be environmentally accountable, help workplace diversity and grow products security and excellent.
Harris James Associates New York, ensures that our clients possess the best info on which to base intelligent business and financial decisions in pursuit of superior investment performance. In order to achieve and maintain that standard of information and timely advice, management and staff are committed to a level of excellence in research, market intelligence, trade executions, and client service that is both demanding and rewarding. We judge our success in maintaining that high level of excellence by the one true measurement; the satisfaction and investment performance of our growing clientele. At Harris James Associates, the Client's success is our primary objective. Investment success in these volatile times can be fleeting for many, which is why our commitment to excellence in everything we do will be a constant regardless of the often turbulent world around us.
RI tactics supply investors using the opportunity to produce beneficial modify on the planet by their personal decisions whilst remaining concentrated on their long-term investment strategy.
Investing funds in a socially aware method has gained reputation given that the 1970s, while the origins of your idea is often traced again for the 17th century. The idea grew for any number of good reasons, including concerns with regards to the setting, purchaser and employee rights, and army actions.
Lots of individuals who had been civil rights and anti-war protestors in the 1960s grew to become traders inside 1970s and 1980s and had been searching for a way to express their convictions via their investment portfolios. The 1st mutual fund to display investments dependant on social criteria was established in 1971.
Right now, greater than 200 mutual money give investors a way to entry a social investment system. Some money are broad in nature, even though other individuals focus on a distinct bring about.
According to your Social Investment Forum, in 2007, just about one from each and every 9 dollars below qualified management within the U.s. (in excess of $2.71 trillion) was associated with socially accountable investing, outpacing the overall marketplace. Curiosity within this investment method has grown greatly given that the mid-1990s.
Alongside money and other professionally managed portfolios that specialize in socially accountable types, the Social Investment Forum studies that mainstream funds managers are also incorporating social and environmental screens into their investment choice processes. The strategy has also taken on world wide dimensions, as far more investors throughout the entire world find to promote specific leads to by way of their investment dollars.
Final results might be favorable
An indication from the aggressive performance of SRI funds will be the functionality of SRI indexes. The longest-running SRI index, the Domini 400, was started in 1990 and continues to carry out competitively. When benchmarking this index versus the S&P 500, the Domini 400 showed a 10.83% return vs. 10.33% total returns using the S&P 500.
Implementing social awareness in different ways
How can socially accountable investing be applied? This is something that can transform from investor to investor, dependant upon each individual’s views. Generally, there are three ways that investors can try to effect alter by way of their investment decisions:
• Social screening. Eliminating companies from consideration for inclusion within a portfolio as a consequence of particular practices or styles of business it pursues. Several social investors avoid companies whose products and solutions and business practices are harmful to people today, communities or the environment.
• Shareholder activism. In some cases, traders or groups of traders (this can involve mutual fund managers) will try to influence the behavior of a firm or selections by its board of directors. When this often is centered on improving financial overall performance, activism may also be a strategy to adjust a company’s business practices that might be considered detrimental to society.
This can involve filing shareholder resolutions on topics like as company governance, political contributions, gender/racial discrimination, pollution and problem labor practices, among other problems.
• Community investing. Institutions use investor capital to finance or guarantee loans to individuals or organizations to improve their own communities. Community investing projects are small and local and normally target on affordable housing, small business startups, improving community facilities and empowering minorities.
Mutual funds vs. individual investing
For most traders, mutual money offer an easy approach to gain entry towards the world of individual investing. Traders have a huge array of options available and the ability to select funds to invest in large-cap, mid-cap and small-cap stocks, and even in bond funds with a socially aware angle.
Those who invest in individual securities or use a professionally managed account have the ability to get a lot more selective in screening investments. This tactic may be most appropriate for investors whose screening criteria are extra unique than would occur with a mutual fund.
Themes arise with the times
Major social problems can usually drive the interests of investors in terms in the social screens they favor. Inside 1970s and 1980s, there was a terrific deal of pressure on investment managers to avoid investments in companies doing business in South Africa, at a time when the country maintained a policy of apartheid. From the 1990s, tobacco companies took center stage. Tobacco currently represents the most popular social display employed in socially accountable mutual funds.
Currently, there is increasing focus on the setting, as worldwide warming has turn out to be a headline issue. Consumers have taken a larger curiosity in environmentally friendly goods like hybrid cars and energy-efficient lightbulbs.
That same interest extends to investing, as far more people seek out “green” money. These portfolios could screen stocks of companies with poor pollution records and might look for to invest in technologies like as solar and wind power development.
Investing in your priorities
A socially accountable strategy allows people today to invest within a way that is consistent with their own priorities. As indicated by overall performance in recent years, choosing to invest in this method does not mean sacrificing potential return. Having said that, not all investments will execute within the same way.
If this strategy of investing interests you, work with your economical advisor to learn more about how SRI options can work in conjunction with your over-all investment strategy. There are several mutual funds to choose from that can be incorporated into an existing or proposed asset allocation tactic. Alternatively, you can select unique investments that fit far more particular standards or apply your own social screens for your managed portfolio. Be sure to consider how any investment you choose matches your risk profile and your return expectations.
The most effective tactic to socially responsible investing is to make sure that the execution from the system is consistent with your general economic plan. Your monetary advisor can assistance you review your current asset allocation and enable you consider whether social investing is correct for you.
James Harris stars with bat and ball as Alastair Cook flops for Essex
http://www.telegraph.co.uk/sport/cricket/8475063/James-Harris-stars-with-bat-and-ball-as-Alastair-Cook-flops-for-Essex.html
James Harris emerged as Glamorgan's star on the opening day of their LV= County Championship match against Essex at Chelmsford.
First the 20-year-old put together a well-constructed 53 in the lower order to usher the visitors to a respectable 282 total after they had been put in to bat.
Then Harris shone with the ball as he claimed the prized wicket of Alastair Cook, the England opener falling lbw for five as Essex closed on 13 for one in reply.
Harris' performance was a boost for the Welsh county although they were no doubt disappointed to not post a bigger total given the fact several of their batsmen failed to make substantial scores when looking well set.
Although William Bragg made 55, three of his colleagues were dismissed in the 30s, making Harris' late rally all the more vital.
Glamorgan's hopes of making a good start to their innings were dented by David Masters, who removed openers Gareth Rees and Alviro Petersen during his first five overs.
Rees (8) fell lbw while Petersen (21) was left hearing the rattle of timber as he played down the wrong line with the total on 33.
The dismissal of the skipper heralded the arrival of Michael Powell to do battle on a ground where he scored a double century five years ago.
He was just beginning to impose himself again when, having reached 36, he was undone by the extra lift of Lonwabo Tsotsobe and was caught behind by James Foster, one of four catches taken by the Essex captain.
Powell's removal ended a third-wicket stand of 61, the best of the innings, while Bragg, whose effort contained eight boundaries, was finally dismissed by Maurice Chambers with the help of Foster.
That was also the combination that ended Harris' fine effort, one containing seven fours. It was only his third half-century in the championship, his last an unbeaten 76 on the same ground in 2009.
Chambers emerged at Essex's most successful bowler with three for 63 from 17 overs, while Masters, Tsotsobe and Ravi Bopara picked up two each.
When Essex replied, Cook despatched the first ball he received from Adam Shantry to the boundary with a flashing square cut.
But then Harris struck to leave Cook reflecting on a poor start to the season. Although he scored 155 in the last game against Northants, he has failed to reach 40 in six other trips to the middle - not the sort of form befitting a batsman who amassed 766 in last winter's Ashes series in Australia.
Rees (8) fell lbw while Petersen (21) was left hearing the rattle of timber as he played down the wrong line with the total on 33.
The dismissal of the skipper heralded the arrival of Michael Powell to do battle on a ground where he scored a double century five years ago.
He was just beginning to impose himself again when, having reached 36, he was undone by the extra lift of Lonwabo Tsotsobe and was caught behind by James Foster, one of four catches taken by the Essex captain.
Powell's removal ended a third-wicket stand of 61, the best of the innings, while Bragg, whose effort contained eight boundaries, was finally dismissed by Maurice Chambers with the help of Foster.
That was also the combination that ended Harris' fine effort, one containing seven fours. It was only his third half-century in the championship, his last an unbeaten 76 on the same ground in 2009.
Chambers emerged at Essex's most successful bowler with three for 63 from 17 overs, while Masters, Tsotsobe and Ravi Bopara picked up two each.
When Essex replied, Cook despatched the first ball he received from Adam Shantry to the boundary with a flashing square cut.
But then Harris struck to leave Cook reflecting on a poor start to the season. Although he scored 155 in the last game against Northants, he has failed to reach 40 in six other trips to the middle - not the sort of form befitting a batsman who amassed 766 in last winter's Ashes series in Australia.
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