Our firm has extensive experience working with organisations across the industry, including: proprietary and generic drug manufacturers, specialty drug makers, medical device and diagnostics suppliers, biotechnology companies, wholesalers, pharmacy benefit managers, contract research organisations, and industry associations. We have made a deep commitment to understanding the forces affecting our clients' operations and have aligned our practice with the market to ensure that our people are deeply knowledgeable about the relationships that suppliers have with providers, payers, regulators and patients.
Whether you are an emerging company seeking venture capital to fund research or advice on a collaboration to commercialize a product, or an established company looking to improve or expand operations, you can count on our insight and experience to find the best approaches to achieve your financial, operational and strategic objectives.Tuesday, December 11, 2007
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Over the past decade, pharmaceutical and life sciences companies have entered a difficult period where shareholders, the market and regulators have all created significant pressures for change within the industry. From thinning pipelines and skyrocketing operating costs to calls for lower prices and a greater regulatory burden, the industry is confronting unprecedented challenges that are expected to radically transform the business. Biotechnology companies also face increasingly tougher choices about product development strategy, funding sources, collaboration arrangements and the competition for talent. To overcome these challenges, the industry will require a bold vision and leaders who have the willingness to embrace a fundamentally new approach to their business
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By 2020 the pharmaceutical market is anticipated to more than double to $1.3 trillion, with the E7 countries - Brazil, China, India, Indonesia, Mexico, Russia and Turkey - accounting around one fifth of global pharmaceutical sales. Further, incidence of chronic conditions in the developing world will increasingly resemble those of the developed world. But Pharma 2020: the vision - which path will you take? indicates that the current pharmaceutical industry business model is both economically unsustainable and operationally incapable of acting quickly enough to produce the types of innovative treatments demanded by global markets. In order to make the most of these future growth opportunities, the industry must fundamentally change the way it operates.
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KEMSTRO™ (baclofen orally disintegrating tablets) is a muscle relaxant and antispastic. Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Its chemical name is 4-amino-3- (4-chlorophenyl)-butanoic acid. The molecular weight of baclofen is 213.66 and the empirical formula is C10H12C1NO2. The structural formula is represented below
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n a prepared statement released Monday, AstraZeneca said it "supports the conclusion made by the FDA that the overall benefit/risk profiles of omeprazole (Prilosec) and Nexium remain unchanged. AstraZeneca continues to be confident in the safety profiles of omeprazole and Nexium."
However, Seligman did say that the FDA continues to investigate whether the drugs increase the risk of hip fracture. A report in the Dec. 27, 2006, issue of the Journal of the American Medical Association found that people 50 and older who took Prilosec or Nexium had a 44 percent higher risk of hip fracture than people not taking these drugs.
Prilosec and Nexium are drugs known as proton pump inhibitors, which treat the symptoms of GERD and other conditions caused by excess stomach acid.
AstraZeneca says more than 1 billion patients worldwide take the drugs, according to Bloomberg News.n a prepared statement released Monday, AstraZeneca said it "supports the conclusion made by the FDA that the overall benefit/risk profiles of omeprazole (Prilosec) and Nexium remain unchanged. AstraZeneca continues to be confident in the safety profiles of omeprazole and Nexium."
However, Seligman did say that the FDA continues to investigate whether the drugs increase the risk of hip fracture. A report in the Dec. 27, 2006, issue of the Journal of the American Medical Association found that people 50 and older who took Prilosec or Nexium had a 44 percent higher risk of hip fracture than people not taking these drugs.
Prilosec and Nexium are drugs known as proton pump inhibitors, which treat the symptoms of GERD and other conditions caused by excess stomach acid.
AstraZeneca says more than 1 billion patients worldwide take the drugs, according to Bloomberg News.n a prepared statement released Monday, AstraZeneca said it "supports the conclusion made by the FDA that the overall benefit/risk profiles of omeprazole (Prilosec) and Nexium remain unchanged. AstraZeneca continues to be confident in the safety profiles of omeprazole and Nexium."
However, Seligman did say that the FDA continues to investigate whether the drugs increase the risk of hip fracture. A report in the Dec. 27, 2006, issue of the Journal of the American Medical Association found that people 50 and older who took Prilosec or Nexium had a 44 percent higher risk of hip fracture than people not taking these drugs.
Prilosec and Nexium are drugs known as proton pump inhibitors, which treat the symptoms of GERD and other conditions caused by excess stomach acid.
AstraZeneca says more than 1 billion patients worldwide take the drugs, according to Bloomberg News.n a prepared statement released Monday, AstraZeneca said it "supports the conclusion made by the FDA that the overall benefit/risk profiles of omeprazole (Prilosec) and Nexium remain unchanged. AstraZeneca continues to be confident in the safety profiles of omeprazole and Nexium."
However, Seligman did say that the FDA continues to investigate whether the drugs increase the risk of hip fracture. A report in the Dec. 27, 2006, issue of the Journal of the American Medical Association found that people 50 and older who took Prilosec or Nexium had a 44 percent higher risk of hip fracture than people not taking these drugs.
Prilosec and Nexium are drugs known as proton pump inhibitors, which treat the symptoms of GERD and other conditions caused by excess stomach acid.
AstraZeneca says more than 1 billion patients worldwide take the drugs, according to Bloomberg News.n a prepared statement released Monday, AstraZeneca said it "supports the conclusion made by the FDA that the overall benefit/risk profiles of omeprazole (Prilosec) and Nexium remain unchanged. AstraZeneca continues to be confident in the safety profiles of omeprazole and Nexium."
However, Seligman did say that the FDA continues to investigate whether the drugs increase the risk of hip fracture. A report in the Dec. 27, 2006, issue of the Journal of the American Medical Association found that people 50 and older who took Prilosec or Nexium had a 44 percent higher risk of hip fracture than people not taking these drugs.
Prilosec and Nexium are drugs known as proton pump inhibitors, which treat the symptoms of GERD and other conditions caused by excess stomach acid.
AstraZeneca says more than 1 billion patients worldwide take the drugs, according to Bloomberg News.
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n a prepared statement released earlier in the day, the FDA also said: "Based on everything now known at the agency, the reported difference in the frequency of heart attacks and other heart-related problems seen in the earlier analyses of the two small long-term studies does not indicate the presence of a true effect."
And it added, "FDA recommends that health-care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs."
Dr. Paul O. Katz, chairman of gastroenterology at Albert Einstein Medical Center in Philadelphia, agreed that these drugs are safe and that patients shouldn't hesitate to use them.
"This is altogether good news," Katz said. "It is reassuring to physicians and the public, who are using these drugs on a widespread basis, that this is not deemed to be an issue."
Both drugs are made by the British pharmaceutical company AstraZeneca. In May, the company gave the FDA findings from two small, preliminary trials that were designed to test the effectiveness of the drugs, compared with surgery, for severe gastroesophageal reflux disease (GERD).
During the trials, some cardiac "events" were seen among study participants, hinting that long-term use of Prilosec and Nexium could increase the risk of heart attack, heart failure and heart-related sudden death, the FDA said at the time.
Because of these concerns, AstraZeneca gave the FDA more detailed data from the two initial studies as well as findings from 14 other studies -- one 14 years in length -- that compared the drugs with a placebo.
The more complete data showed that patients taking Prilosec had a lower risk of heart problems than patients taking a placebo. And findings from the ongoing Nexium trial found no difference in heart problems between patients taking the drug and those undergoing surgery for GERD, the FDA statement said.
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MONDAY, Dec. 10 (HealthDay News) -- A U.S. government review of the popular heartburn drugs Prilosec and Nexium found no evidence of increased heart risks, health officials said Monday.
The announcement followed a three-month safety review after reports of possible heart risks emerged from two preliminary studies. But detailed data from both studies, plus another 14 studies, showed no heightened risk associated with long-term use of the drugs, U. S. Food and Drug Administration officials said.
Dr. Paul Seligman, associate director of the FDA's Office of Safety Policy and Communication at the Center for Drug Evaluation and Research, told reporters that the agency "had completed our safety review, and our current assessment is that studies do not show a risk for heart attack or heart-related problems."
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