Tag: FDA approval
It’s Getting Harder to Come Up With a Successful Drug
by Melly Alazraki on Feb.17, 2011, under Towing
The odds of shepherding a new drug to market in recent years has fallen to nearly one in 10 — about half of the previous rate, according to a new study released this week. First, a new treatment must survive several layers of clinical studies — and then the FDA approval process. That trip is getting tougher.
Continue reading It’s Getting Harder to Come Up With a Successful Drug
It’s Getting Harder to Come Up With a Successful Drug originally appeared on DailyFinance on Thu, 17 Feb 2011 10:00:00.
Filed Under: Investing, Health Care
Inside Wall Street: Two Good Reasons for Clinical Data Shares to Soar Again
by Gene Marcial on Feb.14, 2011, under Towing
From October 2010 to February 2011, biotech Clinical Data’s stock doubled, mostly thanks to FDA approval of its novel antidepressant. But also pushing the stock up — and making it likely to perhaps double again — is speculation that a Big Pharma will buy Clinical Data.
Continue reading Inside Wall Street: Two Good Reasons for Clinical Data Shares to Soar Again
Inside Wall Street: Two Good Reasons for Clinical Data Shares to Soar Again originally appeared on DailyFinance on Mon, 14 Feb 2011 08:00:00.
Filed Under: Company News, Columns, Investing, Health Care, Pfizer, Stock Picks, Merck, GlaxoSmithKline, Eli Lilly
FDA Rejects Orexigen’s New Diet Drug Over Heart Concerns
by Melly Alazraki on Feb.01, 2011, under Towing
In a surprise move Tuesday, the FDA rejected Orexigen’s proposed new diet drug Contrave, saying the company needed to run another study of its cardiovascular risks. With this rejection, all three of a slate of similar diet drugs from competing pharmaceuticals have been turned back by the agency.
Continue reading FDA Rejects Orexigen’s New Diet Drug Over Heart Concerns
FDA Rejects Orexigen’s New Diet Drug Over Heart Concerns originally appeared on DailyFinance on Tue, 01 Feb 2011 11:17:00.
Filed Under: Company News, Health Care, Stocks in the News
AstraZeneca’s Brilinta Fails to Win FDA Approval
by Melly Alazraki on Dec.17, 2010, under Towing
The FDA disappointed AstraZeneca and its investors by not approving its heart drug Brilinta, a blood-thinner that the company — facing a severe patent cliff — has high hopes for. If approved, it could be a multibillion-dollar blockbuster. But the FDA wants to see more analyses of results from a major study.
Continue reading AstraZeneca’s Brilinta Fails to Win FDA Approval
AstraZeneca’s Brilinta Fails to Win FDA Approval originally appeared on DailyFinance on Fri, 17 Dec 2010 08:08:00.
Filed Under: Company News, Health Care, Pfizer, Bristol-Myers Squibb, Sanofi Aventis, Astrazeneca, Stocks in the News
FDA Is Set Decide the Fate of AstraZeneca’s Heart Drug Brilinta
by Melly Alazraki on Dec.15, 2010, under Towing
More than a year after AstraZeneca filed for approval, the FDA will make its decision on Thursday. A large study showed the blood thinner worked better than Plavix for treating acute coronary syndrome — but approval isn’t a sure thing, due in part to some oddities in the study’s results.
Continue reading FDA Is Set Decide the Fate of AstraZeneca’s Heart Drug Brilinta
FDA Is Set Decide the Fate of AstraZeneca’s Heart Drug Brilinta originally appeared on DailyFinance on Wed, 15 Dec 2010 09:35:00.
Filed Under: Company News, Health Care, Bristol-Myers Squibb, Sanofi Aventis, Eli Lilly, Astrazeneca, Stocks in the News
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