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Biotech generics bill introduced in Congress 1:51 PM 3/16/2009
Modern Medicine - Woodcliff Lake,NJ,USA
A toothless bipartisan bill that hopes the US Food and Drug Administration may one day approve affordable copies of biotech drugs has been introduced in Congress. Wow, that was easy. ...

US FDA memo backs Sanofi heart drug Multaq 9:42 AM 3/16/2009
Reuters - USA
Multaq from Sanofi-Aventis should be approved for delaying symptoms of atrial fibrillation. ...

United Therapeutics lung drug faces delay, shares drop 8:47 AM 3/16/2009
Forbes - NY,USA
United Therapeutics Corp's portable nebulizer that delivers the drug Tyvaso to treat pulmonary hypertension could see approval delays to conduct an additional study. ...

Avexa Surges After HIV Drug Doesn’t Raise Cholesterol in Study 5:57 AM 3/16/2009
Bloomberg - USA
Avexa said that patients who took apricitabine didn’t show elevated levels of cholesterol or triglycerides after the 96-week trial. ...

Merck continues to rally on Schering drug data 7:40 AM 3/15/2009
Forbes - NY,USA
Merck and Co's outlook looks good after its planned acquisition Schering-Plough reported that anti-clotting drug candidate SCH 530348 met its chief goal in a mid stage clinical trial. ...

The Future Of The FDA 6:05 AM 3/14/2009
Forbes - NY,USA
President Obama has selected Margaret Hamburg and Joshua Sharfstein to serve as commissioner and deputy commissioner of the US FDA. ...

European Heart Patients’ Drug Reliance Fails to Boost Health 6:47 AM 3/13/2009
Bloomberg - USA
Heart patients in Europe failed to quit smoking, didn't lose weight or improve their lifestyles. They did take more meds which did not help their overall health in a 12 year study. ...

Gilead $1.4 Bln CV Therapeutics Deal Tops Astellas 12:24 PM 3/12/2009
Bloomberg - USA
Gilead Sciences Inc agreed to buy CV Therapeutics Inc for about $1.4 billion beating the hostile offer from Japan’s Astellas Pharma Inc. ...

Pfizer halts trial for cancer drug after seeing benefit 9:10 AM 3/12/2009
MarketWatch - USA
Pfizer Inc said that a Phase 3 trial of its Sutent cancer drug has been halted early thanks to "significant benefit" in patients with advanced pancreatic islet cell tumors. ...

Targacept ends development of nerve pain drug 6:35 PM 3/11/2009
Forbes - NY,USA
Targacept Inc is ending work on its TC-6499 drug candidate it was developing with GlaxoSmithKline as a nerve pain treatment. It was not effective. ...

Former New York Health Commissioner Picked to Lead FDA 5:05 PM 3/11/2009
New York Times - United States
President Obama intends to nominate Dr. Margaret A. Hamburg to lead the Food and Drug Administration. She was formerly New York City health commissioner. ...

Sepracor ends Xopenex litigation with Teva 12:22 PM 3/11/2009
Bizjournals.com - Charlotte,NC,USA
Sepracor Inc reached a licensing agreement and settled litigation with Teva Pharmaceuticals over inhaled asthma drug Xopenex (levalbuterol). ...

US lawmakers propose generic biotech drug plan 10:22 AM 3/11/2009
Reuters - USA
US lawmakers unveiled a proposal for government approval of generic copies of biotechnology drugs. Democrat Henry Waxman would give brand-name companies up to five years of market exclusivity. It's unlikely that Waxman has details on how to guarantee that cheap copies won't kill people. ...

Stryker's biotech unit is under US review 5:26 AM 3/11/2009
Boston Globe - United States
Stryker Corp is being investigated by a US grand jury. Charges involve product promotion, misbranding, and submission of false reports to regulators for its OP-1 products and Calstrux bone filler. ...

Eli Lilly granted request to halt generic launch 9:41 AM 3/10/2009
Forbes - NY,USA
Eli Lilly & Co said a US district court granted its request to temporarily halt Teva Pharmaceutical Industries Ltd from launching a generic version of the osteoporosis drug Evista (raloxifene). ...

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