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US
FDA staff benefits, risk with Bristol drug 6:22 AM 2/25/2010
Reuters
Studies of Bristol-Myers Squibb Co's experimental kidney transplant
drug belatacept show improved blood pressure and other benefits with risk of death still a factor.
...
Glaxo
fires off 30-page rebuttal of Avandia claims 12:29 PM 2/24/2010
Reuters
GlaxoSmithKline stepped up the defense of its diabetes drug Avandia with the
company's official response rejecting a critical Senate finance committee report.
. ...
Roche
cancer drug Xeloda gets new EU recommendation 6:13 AM 2/24/2010
Reuters
Roche Holding AG's blockbuster cancer drug Xeloda received a European
Union recommendation for a treatment of early colon cancer in combination with Sanofi-Aventis' Eloxatin
(oxaliplatin).
...
FDA
panel backs Salix drug for brain damage 5:50 PM 2/23/2010
BusinessWeek
A US FDA advisory panel recommended Salix Pharmaceutical's drug
Xifaxan be approved to treat brain damage caused by liver failure.
...
FDA
approves Gilead cystic fibrosis drug Cayston 3:10 PM 2/23/2010
BusinessWeek
The US FDA cleared Gilead Sciences Inc's drug Cayston as a
treatment for respiratory symptoms of cystic fibrosis.
...
FDA
warns of heart problem with HIV drug combo 12:11 PM 2/23/2010
Reuters
The US FDA said that HIV drugs Invirase and Norvir might lead to an
abnormal heart rhythm when used in combination.
...
Watson,
Biovail in lawsuit over depression drug 10:46 AM 2/22/2010
Forbes
Watson Pharmaceuticals is being sued for patent infringement by Biovail
Corp after it sought federal approval for a generic version of that company's anti-depression drug Aplenzin
ER (bupropion).
...
BioSante
says panel recommends drug trial to continue 8:51 AM 2/22/2010
Reuters
BioSante Pharmaceuticals said an independent panel recommended the
continuation of a late-stage study on its lead candidate LibiGel to treat sexual dysfunction in menopausal
women.
...
NasVax
says inks vaccine research deal with Novartis 2:04 AM 2/22/2010
Reuters
NasVax Ltd said it signed an agreement with Novartis to jointly
investigate the feasibility of developing vaccines using its VaxiSome technology.
...
Glaxo's
Diabetes Drug Tied to Heart Problems by FDA, NYT
Says 2:21 PM 2/20/2010
Bloomberg
The
New York Times cites a confidential US FDA report that GlaxoSmithKline’s Avandia drug for diabetics may cause
heart attacks and heart failure. The report recommends removing Avandia from the market.
...
Generics
Face Longer Wait for Approval 5:04 AM 2/20/2010
New York Times
The number of applications for new generic drugs exceeds the US FDA's
capacity to review them leaving a backlog of nearly 2,000 pending generic applications. That's more than
double the backlog in 2005.
...
US
FDA to decide on Amgen osteoporosis drug by July 3:04 PM 2/19/2010
Reuters
The US FDA has accepted Amgen Inc's application for experimental
osteoporosis drug Prolia hoping to make its approval decision by July 25.
...
GenVec
signs vaccine development contract with DHS 12:10 PM 2/19/2010
BusinessWeek
GenVec said it signed a new contract with the Department of Homeland
Security to develop vaccines against foot-and-mouth disease.
...
US
FDA staff see concerns with Salix trial 10:54 AM 2/19/2010
Reuters
The US FDA cited concerns with Salix Pharmaceuticals' clinical trial looking at a
new use of its diarrhea drug Xifaxan to treat a liver disorder.
...
EU
agency recommends Glaxo kidney cancer drug 5:10 AM 2/19/2010
Reuters
European regulators recommended GlaxoSmithKline's new kidney cancer
drug Votrient for conditional approval. This follows approval from the US FDA in October.
...
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