AstraZeneca Rethinking Blockbuster Model After Exanta “Not Approvable”
FDA's "not approvable" decision for AstraZeneca's Exanta highlights the increasing difficulty of developing drugs with blockbuster potential while satisfying strict regulatory standards
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Heart Attack Signal Is Likely Focus For Panel Review Of Boehringer Ingelheim's Pradaxa
When FDA's Cardiovascular and Renal Drugs Advisory Committee meets Sept. 20 to consider Boehringer Ingelheim's Pradaxa (dabigatran) for stroke prevention, a significantly higher rate of heart attacks among clinical trial patients compared with warfarin is likely to come up.
J&J’s Xarelto Wins Favorable Committee Vote, But Will FDA Delay Approval For ATLAS Data?
Cedars-Sinai cardiologist Kaul and Public Citizen’s Wolfe are the two "no" votes in 15-2 panel nod for the anti-coagulant.
Drug-Induced Liver Injury Workshop Offers More Questions Than Answers
To fully understand an experimental drug's potential for liver toxicity, clinical trials should be better designed to reflect real-world populations, including patients with liver disease, but neither FDA nor experts from industry and academia at a recent workshop on the topic were able to provide many answers on how to do so safely