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New FDA Chief Says She'll Toughen Enforcement Efforts 4:27 AM 6/17/2009
New York Times - United States
Regulatory science may become a legitimate, important, and really interesting branch of science. ...

Virus shuts Genzyme plant, holds up drugs for 8000 3:27 AM 6/17/2009
Boston Globe - United States
Unlike traditional chemical-based drug production slight changes in temperature or pH can affect a biotech product. Complexity and a patient population of only 8000 worldwide make a good argument againts biogenerics. ...

US FDA panel urges approval of Savient gout drug 4:36 PM 6/16/2009
Reuters - USA
A US advisory panel recommended that Savient Pharmaceuticals' experimental gout drug is safe and effective for certain patients with the debilitating joint disorder and should be approved. ...

Genentech Ordered to Cease Three Drug Projects as Arbitrator Sides 3:33 PM 6/16/2009
Wall Street Journal - USA
Genentech unit of Roche Holding must cease three drug development projects under terms of a contract with Biogen Idec. Genentech was allowed to continue late-stage clinical trials for ocrelizumab to treat lupus and rheumatoid arthritis. ...

Zicam may damage sense of smell - FDA 2:36 PM 6/16/2009
CNNMoney.com - USA
The US FDA advised consumers to discontinue use of Zicam Cold Remedy nasal gel and related products because they can can permanently damage the sense of smell. The anosmia may be long-lasting or permanent. ...

Genzyme Plant Closure Hits Key Drugs, Raises Issues 10:51 AM 6/16/2009
Wall Street Journal - USA
Genzyme Corp said a manufacturing plant will be out of commission for at least a month after discovering a virus in a "bioreactor" used to make biologic drugs. Mr. Obama should follow this one before touting bio generics as a healthcare money saver. ...

Chemotherapy Drug May Reverse Signs of Aging 8:24 AM 6/16/2009
FOXNews - USA
Researchers found that the cancer drug fluorouracil reduced the appearance of sun-damaged skin after being applied for just two weeks. Fluorouracil damages skin cells forcing the body to rebuild them. ...

FDA delays GSK, Genmab leukaemia drug ruling 3 mths 7:44 AM 6/16/2009
Reuters - USA
GlaxoSmithKline and Genmab said that the US FDA is delaying the deadline to rule on leukemia treatment Arzerra by three months to review additional chemistry and manufacturing data. ...

Covidien signs deal to expand pain drug offerings 6:40 AM 6/16/2009
Forbes - NY,USA
Covidien PLC signed a license and development deal with Nuvo Research Inc to expand its branded pain offerings. ...

Galapagos enters clinical trials with second drug 4:35 AM 6/16/2009
Reuters - USA
Biotech company Galapagos said it started clinical trials for its bone metastasis drug GLPG0187 to prevent metastasis of cancers to bone. ...

Generic Biotech Drugs: Cure or Quagmire? 3:33 AM 6/16/2009
BusinessWeek - USA
Quagmire. Biologics are not standard drugs made of simple chemicals. They are complex proteins cloned and then grown in expensive cellular systems. How hard is it for Obama, Waxman, and the FTC to figure out that there is no free ride here. ...

US FDA questions heart risk findings on ADHD drugs 10:45 AM 6/15/2009
Reuters - USA
There may be an association between use of stimulant attention deficit hyperactivity disorder (ADHD) medications and sudden cardiac death in healthy children. The US FDA says that the limited study should not prompt parents to stop giving the medications to their kids. Has the FDA ever been wrong? ...

Jazz Pharma's pain drug significantly reduces symptoms 8:43 AM 6/15/2009
Reuters - USA
Jazz Pharmaceuticals said its experimental JZP-6 (sodium oxybate) treatment for fibromyalgia significantly reduced pain. ...

Glaxo, Dr Reddy to develop emerging market drugs 8:03 AM 6/15/2009
Forbes - NY,USA
GlaxoSmithKline has reached a deal with Dr. Reddy's Laboratories to develop and market selected products for emerging markets. ...

Boehringer, Vitae ink $242 mln Alzheimer's deal 7:53 AM 6/15/2009
Reuters - USA
Boehringer Ingelheim has signed a deal worth up to $242 million with US biotech company Vitae Pharmaceuticals to research and develop new Alzheimer's drugs. ...

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