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Latest From Brenda Sandburg
A look at the evolution of litigation, from Amgen's 'bold' at-risk launch of Herceptin and Avastin biosimilars to the jump in settlements, new battles over manufacturing information and an expected petition to the Supreme Court.
Court rejects Sandoz's arguments that patents covering Enbrel's active ingredient and method of manufacture are invalid; decision comes three years after FDA approved Sandoz's biosimilar.
AAM, Upsher-Smith, APhA, and Cigna tell US FDA that packaging requirement will increase manufacturing and drug costs, create reimbursement hurdles and reduce access to medicines. Daiichi-Sankyo supports agency's proposal.
Public meeting scheduled for November to seek recommendations for policies that FDA could implement short-term to promote drug development programs.
US FDA's Rush Following Novartis' Delay Suggests Strong Displeasure With Handling Of Zolgensma Data Manipulation
Early release of inspection findings is unusual, signaling likelihood that Novartis will face tough scrutiny of its actions, and perhaps stiff fines because of the fraud.