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Phase 3 Trial Initiated in Hodgkin Lymphoma

[ Price : $8.95]

Millenium: The Takeda Oncology Co. and Seattle Genetics initiate a Phase 3 clinical study of Adcetris as part of a chemotherapy re...

CDER Clarifies New Policy on Extended-release Generics

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FDAs order last month for Teva to withdraw its generic bupropion extended-release 300mg product prompts the agency to pay closer a...

BioCryst Pulls IND for HCV Investigational Drug

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BioCryst Pharmaceuticals withdraws its IND for the antiviral nucleoside, BCX5191 after FDA expressed concerns about its preclinica...

Navidea Resubmits Lymphoseek NDA

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Navidea Biopharmaceuticals resubmits its Lymphoseek NDA to FDA to answer agency questions about third-party cGMPs.

Ameridose Compounding Firm Recalls Drug Products

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Ameridose, the sister company of troubled New England Compounding Center, recalls all unexpired products remaining in circulation ...

Biogen Idec Plans BLA for Clotting Factor

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Biogen Idec plans to submit a BLA in the first half of 2013 for a long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc...

CDRH Puzzled By Increasing Class 1 Recalls

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CDRH says it is puzzled by an increase in Class 1 medical device recalls seen over the past four years.

Learned Intermediary Helps Florida Failure-to-warn Defense

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Attorney Mimi Davis says the learned intermediary doctrine may be a defense in failure-to-warn cases being tried under Florida law...

Gilead Phase 2 Study of HIV Drug Meets Primary Objective

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Gilead Sciences says a Phase 2 clinical trial evaluating tenofovir alafenamide fumarate for treating HIV-1, has met its primary ob...

Cubist Begins Phase 3 Trial for Opioid-Induced Constipation

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Cubist Pharmaceuticals initiates a Phase 3 clinical study of CB-5945 in patients with opioid-induced constipation.