GSK/Theravance file COPD therapy in Europe

By SELINA MCKEE GSK and Theravance have submitted their new chronic obstructive pulmonary disease (COPD) maintenance therapy to EU regulators for approval, hot on the heels of a filing ...

FDA Panel Backs J&J Diabetes Drug

By JENNIFER CORBETT DOOREN WASHINGTON—A federal advisory panel backed a proposed Johnson & JohnsonJNJ +0.61% diabetes drug amid concerns about potential cardiovascular risks ...

FDA Requires Lower Doses for Certain Insomnia Drugs

By JENNIFER CORBETT DOOREN WASHINGTON—The Food and Drug Administration is requiring the makers of certain sleep-inducing drugs, including Ambien, to lower doses of the medicines ...

Drugmakers report U.S. shortages of flu vaccine, Tamiflu

(Reuters) – This year’s early and potentially severe flu season has created shortages of the children’s formulation of the leading treatment and most forms of the ...

Pfizer May Push $5 Billion Breast Cancer Hope for Ruling

By Drew Armstrong Pfizer Inc. (PFE), the world’s largest drugmaker, is weighing whether to ask U.S. regulators to expedite their review of a potential $5 billion-a-year treatment ...

JPMorgan Healthcare Conference Highlights: Sarepta Therapeutics

By Sean Williams The JPMorgan Healthcare Conference currently under way in San Francisco is arguably the most important event of the entire year for the health care sector. This ...

What’s on the Way for Antares Pharma

By Keith Speights Count Antares Pharma (NASDAQ: ATRS  ) in the upper echelon of stocks over the past year. Strong demand for the company’s self-injection devices and topical ...

4 Biotech Stocks With Insider Interest

By Mohsin Saeed As the S&P 500 Biotechnology Index shows below, the last year was a good one for the biotechnology industry. Stocks such as Amarin, Vivus, and Arena Pharmaceuticals saw ...

Optimer’s Dificid Sales Look Good

By Zacks Equity Research Optimer Pharmaceuticals Inc. (OPTR) recently announced its preliminary sales for the fourth quarter and full year 2012. Optimer said that preliminary gross ...

Forbes Earnings Preview: Forest Laboratories

By Narrative Science Analysts expect disappointing news from Forest Laboratories (FRX) when it reports its third quarter earnings on Tuesday, January 15, 2013. They project a loss ...

FDA Decision On MAP’s Levadex Approaching, Stock Starting To Reflect Optimism

By Dee Kotak, MD MAP Pharmaceuticals (NASDAQ:MAPP) is set to run higher this quarter into potential approval of the company’s lead product Levadex, a proprietary inhaled version ...

Pain Pill Makers Get Guidance On Deterring Addicts

By Ed Silverman Amid the ongoing debate over the benefits and risks of prescription painkillers, the FDA has issued a draft guidance that attempts to help drugmakers determine which ...
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