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Biotech's Defense Against Generics: FDA 3:12 AM 3/6/2009
TheStreet.com - USA
There won't be an onslaught of cheaper biogenerics. Obama may want it, but absent a magic wand, the FDA has enough to worry about with biotech companies trying to manufacture their own biologic drugs. ...

US FDA to ask panel about Seroquel XR safety issues 12:57 PM 3/3/2009
Reuters - USA
The US FDA asks outside advisers for input on safety concerns surrounding expanded use of AstraZeneca Plc's schizophrenia drug Seroquel XR. ...

FDA clears Cellectar drug for human tests 10:59 AM 3/3/2009
Bizjournals.com - Charlotte,NC,USA
The US FDA has cleared Cellectar Inc's Investigational New Drug application for its (131)I-CLR1404 drug candidate for testing in patients with advanced solid malignancies. ...

Pfizer, Bausch team up to promote eye drugs 9:09 AM 3/3/2009
Reuters - USA
N) and Bausch & Lomb will collaborate on promoting both companies' prescription eye drugs in the United States, significantly increasing the support for the ...

King, Acura pain drug gets priority review 6:48 AM 3/3/2009
Reuters - USA
Acura Pharmaceuticals and King Pharmaceuticals said the US FDA granted a priority review for their experimental pain drug Acurox with target date of June 30. ...

Pfizer, Aurobindo in deal to sell generic drugs 5:06 AM 3/3/2009
The Associated Press
Pfizer will announce that it has reached agreements with Aurobindo Pharma Ltd to produce and sell drugs that have lost patent protection in the US and Europe. Pfizer will handle the marketing. ...

AstraZeneca Warned Japanese Doctors of Diabetes Link 2:27 PM 3/2/2009
Bloomberg - USA
AstraZeneca Plc salespeople told US doctors that antipsychotic drug Seroquel didn’t cause diabetes while telling physicians in Japan of possible links to the disease 2 years earlier. ...

Resistance to flu drug widespread in US: study 1:28 PM 3/2/2009
Reuters - USA
US Centers for Disease Control and Prevention reported that the most common strain of flu H1N1 resists Roche AG's Tamiflu. ...

Targeted Genetics makes deals to get through first half of ’09 1:27 PM 3/2/2009
Bizjournals.com - Charlotte,NC,USA
Targeted Genetics Corp renegotiated its deal with Celladon Corp related to the heart failure drug Mydicar. ...

Genentech May Produce as Many as 15 New Drugs by 2015 12:06 PM 3/2/2009
Bloomberg - USA
Genentech Inc may begin selling 15 new drugs from 2011 to 2015. ...

KV Pharmaceutical in consent decree with FDA 12:03 PM 3/2/2009
Reuters - USA
KV Pharmaceutical Co entered into a consent decree with the US FDA that would allow the company to resume manufacturing and marketing products. ...

Genentech: Worth More Than Pfizer? 4:22 AM 2/28/2009
Forbes - NY,USA
Genentech's market cap of $91 billion exceeds that of bigger Pfizer with $84 billion. Pfizer has annual sales of $48 billion, Genentech $13 billion. ...

Endo ends Durect pain patch deal, licenses drug 12:32 PM 2/27/2009
Forbes - NY,USA
Endo Pharmaceuticals Holdings Corp licensed a new drug candidate from German drug maker Grunenthal and returned the rights to a chronic pain patch to Durect Corp. ...

Amicus Therapeutics suspends Pompe drug study 10:35 AM 2/27/2009
Forbes - NY,USA
Amicus Therapeutics Inc suspended a midstage study of its developing Pompe disease treatment after two patients suffered serious side effects. ...

Somaxon: FDA denies approval for insomnia drug 5:52 PM 2/26/2009
Reuters - USA
Somaxon Pharmaceuticals Inc said the US FDA denied approval for its experimental Silenor treatment for insomnia. Silenor may prolong the cardiac QT interval. ...

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