http://www.your-story.org/harris-james-associates-compiled-news-young-biotech-firms-seek-long-term-relevance-238750/
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.
vrijdag 22 april 2011
Harris James Associates Publishes India Economic Growth, A Closer Look
http://www.newswiretoday.com/news/88176/Harris_James_Associates_Publishes_India_Economic_Growth_A_Closer_Look/
The central government budget which set the tone for reducing fiscal deficit and an unexpected increase in the policy rate to rein in inflation has convinced the markets and economists that India is on its way to having a robust economic growth. Industrial output also continued to grow at a fast pace in January as companies produced more cars and cement. In the fiscal year 2011 that ends in March 2011, GDP growth of 8.5% is achievable. Long-term predictions for the southwest monsoons are expected to be normal, giving a boost to agricultural production and domestic demand. Harris James Associates 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. India Inflation Inflation in India has been surging, driven by a low base and high food prices as the weakest monsoon rains in 37 years last year hurt farm output. Inflation running at 8.5% may have peaked and it is expected to ease by April as the winter-sown crop comes to market. The year-on-year inflation rate for food articles was 16.22% in the week ending March 13, far above the comfortable zone for the central bank and the government. In order to manage the inflationary expectations, the central bank increased overnight lending and borrowing rates by 0.25 percentages point each, making it one of the first major central banks to raise rates. The central bank further announced that it would continue to roll back its loose monetary policy to manage prices, as the country can’t have sustained strong growth with high inflation. We expect a 0.25-percentage-point rate hike in mid-April and another increase of one percentage point through March 2011. The rebound in industrial activity also saw a surge in India’s exports for the third month running in January. Exports in January rose 11.5% from a year earlier to $14.34 billion, after having increased 9.3% to $14.61 billion in December. Imports increased 35.5% in January to $24.70 billion while oil imports rose by 56% to $7.05 billion. Non-oil imports, a barometer of investment activity, grew 28.8% to $17.65 billion. On the back of robust economic numbers and policy pronouncements, the rating agency Standard & Poor’s raised its rating outlook to stable, expecting the fiscal situation to recover and growth to remain strong in the coming years. The government’s commitment to follow the recommendations of the 13th Finance Commission, as well as its move to reduce fertilizer subsidies and raise domestic fuel prices were taken as positive indicators. The country’s external position continues to be in a comfortable zone. It is unlikely that India will benefit from the Google-China spat as the Indian government will not provide the kind of benefits China extends to the manufacturing sector in China. But some relocation is likely to emerge. For example, American companies GoDaddy and Dell have threatened to pull out of China and relocate themselves in India. 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. |
Harris James Associates Compiled News: Young Biotech Firms Seek Long Term Relevance
http://www.onlineprnews.com/news/128031-1303279881-harris-james-associates-compiled-news-young-biotech-firms-seek-long-term-relevance.html
Online PR News – 21-April-2011 –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.
Online PR News – 21-April-2011 –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.
Harris James Associates Socially Accountable Investing
http://www.your-story.org/harris-james-associates-socially-accountable-investing-237855/
Do excellent whilst earning profits: A guidebook to socially accountable investing
What is socially accountable investing?
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.
Do excellent whilst earning profits: A guidebook to socially accountable investing
What is socially accountable investing?
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.
Harris James Associates Socially Accountable Investing
http://www.onlineprnews.com/news/125298-1302674294-harris-james-associates-socially-accountable-investing.html
Online PR News – 14-April-2011 –Do excellent whilst earning profits: A guidebook to socially accountable investing
What is socially accountable investing?
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.
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.
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.
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:
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.
• 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.
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.
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.
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 yo
Harris James Associates: Anthera Pharmaceuticals Successfully Completes Interim
http://www.onlineprnews.com/news/128011-1303278145-harris-james-associates-anthera-pharmaceuticals-successfully-completes-interim.html
Online 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.
Online 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.
Harris James Associates Economy – Closer Look by James Harris
http://goarticles.com/article/Harris-James-Associates-Economy-Closer-Look/4271774/
India Economic Growth - Harris James Associates Economy, A Closer Look
The central government budget which set the tone for reducing fiscal deficit and an unexpected increase in the policy rate to rein in inflation has convinced the markets and economists that India is on its way to having a robust economic growth. Industrial output also continued to grow at a fast pace in January as companies produced more cars and cement. In the fiscal year 2011 that ends in March 2011, GDP growth of 8.5% is achievable. Long-term predictions for the southwest monsoons are expected to be normal, giving a boost to agricultural production and domestic demand.
Harris James Associates 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.
India Inflation
Inflation in India has been surging, driven by a low base and high food prices as the weakest monsoon rains in 37 years last year hurt farm output. Inflation running at 8.5% may have peaked and it is expected to ease by April as the winter-sown crop comes to market. The year-on-year inflation rate for food articles was 16.22% in the week ending March 13, far above the comfortable zone for the central bank and the government. In order to manage the inflationary expectations, the central bank increased overnight lending and borrowing rates by 0.25 percentages point each, making it one of the first major central banks to raise rates. The central bank further announced that it would continue to roll back its loose monetary policy to manage prices, as the country can't have sustained strong growth with high inflation.
We expect a 0.25-percentage-point rate hike in mid-April and another increase of one percentage point through March 2011.
The rebound in industrial activity also saw a surge in India's exports for the third month running in January. Exports in January rose 11.5% from a year earlier to $14.34 billion, after having increased 9.3% to $14.61 billion in December. Imports increased 35.5% in January to $24.70 billion while oil imports rose by 56% to $7.05 billion. Non-oil imports, a barometer of investment activity, grew 28.8% to $17.65 billion.
India Economic Growth - Harris James Associates Economy, A Closer Look
The central government budget which set the tone for reducing fiscal deficit and an unexpected increase in the policy rate to rein in inflation has convinced the markets and economists that India is on its way to having a robust economic growth. Industrial output also continued to grow at a fast pace in January as companies produced more cars and cement. In the fiscal year 2011 that ends in March 2011, GDP growth of 8.5% is achievable. Long-term predictions for the southwest monsoons are expected to be normal, giving a boost to agricultural production and domestic demand.
Harris James Associates 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.
India Inflation
Inflation in India has been surging, driven by a low base and high food prices as the weakest monsoon rains in 37 years last year hurt farm output. Inflation running at 8.5% may have peaked and it is expected to ease by April as the winter-sown crop comes to market. The year-on-year inflation rate for food articles was 16.22% in the week ending March 13, far above the comfortable zone for the central bank and the government. In order to manage the inflationary expectations, the central bank increased overnight lending and borrowing rates by 0.25 percentages point each, making it one of the first major central banks to raise rates. The central bank further announced that it would continue to roll back its loose monetary policy to manage prices, as the country can't have sustained strong growth with high inflation.
We expect a 0.25-percentage-point rate hike in mid-April and another increase of one percentage point through March 2011.
The rebound in industrial activity also saw a surge in India's exports for the third month running in January. Exports in January rose 11.5% from a year earlier to $14.34 billion, after having increased 9.3% to $14.61 billion in December. Imports increased 35.5% in January to $24.70 billion while oil imports rose by 56% to $7.05 billion. Non-oil imports, a barometer of investment activity, grew 28.8% to $17.65 billion.
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