FDA

FDA accepts NDA for myeloma drug

Tuesday, November 29, 2011 11:34 AM

The FDA has accepted Onyx Pharmaceuticals' New Drug Application (NDA)
submission for carfilzomib, a next generation proteasome inhibitor, for the potential treatment of patients with relapsed and refractory multiple myeloma.

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FDA approves Intermezzo to treat insomnia

Monday, November 28, 2011 11:08 AM

The FDA has approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

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Gilead Sciences acquires Pharmasset, looks to duplicate its HIV success in hepatitis C

Monday, November 28, 2011 08:02 AM

Consolidation among drug sponsors continues. 

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Boston Scientific's PROMUS Element Stent receives FDA approval

Wednesday, November 23, 2011 10:31 AM

The FDA has approved Boston Scientific's PROMUS Element plus everolimus-eluting platinum chromium coronary stent system, the company's next-generation drug-eluting stent (DES) technology. The PROMUS Element Stent, designed to provide physicians improved DES performance in treating patients with coronary artery disease, is built on an innovative platinum chromium (PtCr) platform with
the market-leading everolimus drug.  The company plans to begin marketing
the product in the U.S. immediately.

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Tasly Pharmaceuticals selects ICON for phase III T89 trial

Monday, November 21, 2011 04:52 PM

ICON has been selected by Tasly Pharmaceuticals for the company’s global phase III T89 trial. T89, also known as Dantonic pill, aims to become the first traditional Chinese medicine to receive FDA approval in the United States. Dantonic pill is a botanical product for the treatment of chronic stable angina pectoris due to coronary heart disease. It is a modernized version of a traditional Chinese herbal medicine and was approved by the State Food and Drug Administration (SFDA) of China in 1993. Since then, more than 2 billion doses have been used by over 10 million patients. 

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FDA approves EYLEA injection

Monday, November 21, 2011 09:27 AM

The FDA has approved Regeneron Pharmaceuticals' EYLEA (aflibercept) injection for the treatment of patients with neovascular (wet) Age-related Macular Degeneration (AMD) at a recommended dose of 2 milligrams (mg) every four weeks (monthly) for the first 12 weeks, followed by 2 mg every eight weeks (2 months).

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Industry watchers nervous as PDUFA V deadline looms

Monday, November 21, 2011 08:02 AM

PDUFA IV expires Sept. 30, 2012, and several parties already are nervous about its renewal. 

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FDA approves high dose anti-depressant

Thursday, November 17, 2011 11:45 AM

The FDA has approved IntelGenx' lead product, CPI-300, for patients with Major Depressive Disorder. CPI-300 is a novel, high-strength formulation of Bupropion hydrochloride (HCl), the active ingredient in Wellbutrin XL. CPI-300 is the only single dose 450 mg formulation of Bupropion HCl approved by the FDA.

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Benchmark, poised for growth, adds two vice presidents

Monday, November 14, 2011 08:00 AM

Benchmark Research, an Austin, Texas-based group of six investigative sites, is making some strategic hires as it positions itself for growth.

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Rempex raises $67.5 million in Series B financing

Wednesday, November 9, 2011 02:06 PM

Rempex Pharmaceuticals has completed the initial closing of a Series B financing.  New investors Frazier Healthcare Ventures and Vivo Ventures joined existing investors SV Life Sciences, OrbiMed Advisors and Adams Street Partners in committing to a total of $67.5 million for this round.  This financing, together with a previous Series A round, brings the total financing commitment for Rempex to $76 million since the company's founding in June 2011.

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