Agency's newest advisory committee will hold its first meeting July 30-31. The panel was formed to help with FDA reviews of cytokines and other biologicals seeking approval for use in treating cancer. The meeting's agenda has not been released, but reportedly, the committee's first reviews could involve GM-CSF and G-CSF. PLAs for GM-CSF products were filed earlier this year by Immunex and Schering-Plough. Amgen submitted a PLA for G-CSF in December.
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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.’
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
