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Study: Contraceptives/Hormone Replacement May Protect Against Brain Aneurysms
Data shows that oral contraceptives and hormone replacement therapy may yield the additional benefit of protecting against the formation and/or rupture of brain aneurysms.
*Roche to Face Hollywood Stars in Accutane Trial
Roche Holding AG faces a lineup of Hollywood stars in the New Jersey trial of an actor’s lawsuit alleging he suffered the loss of his colon after taking the company’s Accutane acne drug.
Generic Gemzar Could Be Forthcoming as Court Rules Lilly’s Patent Invalid
Generic versions of Eli Lilly’s blockbuster cancer drug Gemzar could hit the market as soon as November after a federal appeals court upheld a lower court ruling invalidating Lilly’s patent on the drug.
Site Contract Breaches May Invite an Inspection, Data Invalidation
Breaches of a trial contract can result in an FDA inspection and invalidate the data gathered at a trial site.
Teva Launches Generic Version of Antidepressant Effexor XR
Teva has begun shipping its generic version of Wyeth’s antidepressant Effexor XR after the FDA approved the company’s ANDA, and the world’s largest generic-drug maker also was awarded 180-day marketing exclusivity.
Aurobindo Pharma Gets FDA OK for Ranitidine Syrup
Aurobindo Pharma has received FDA approval for ranitidine HCl syrup.
Charles River Calls Off WuXi PharmaTech Buy
Charles River Laboratories International, a U.S. medical research equipment and services company, said it is canceling a $1.6 billion acquisition of WuXi PharmaTech after shareholder objections.
Unichem Labs Gets FDA Nod for Hypertension Tabs
Unichem Laboratories has received FDA approval for bisoprolol fumarate and hydrochlorothiazide in tablet form.
Strides Arcolab Receives FDA Approval for Rocuronium Bromide Injection
Strides Arcolab announced the FDA has granted approval of rocuronium bromide 10mg/ml-5ml and 10 ml multidose vials, a nondepolarizing neuromuscular blocking agent.