Senate Finance Committee report and internal FDA analysis on cardiovascular risks associated with GSK's Avandia may revive argument to split CDER into two groups of safety and efficacy reviewers.
There are few drugs approved by FDA that open old regulatory wounds like GlaxoSmithKline's Avandia.
The Type II diabetes therapy has been the subject of intense scrutiny by Congress and FDA ever since Cleveland Clinic cardiologist Steve Nissen published a meta-analysis in the New England...
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.
The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.
The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.
