No FDA communication intended for another company regarding recombinant insulin manufacturing changes was ever received by Aventis, the firm asserts in response to a March 6 story in "The Pink Sheet" (p. 18). The story reported that Aventis had made manufacturing changes for its Insuman Infusat product as a result of FDA's observations. In addition, a semi-synthetic insulin pump product of Aventis, which also goes under the name of Insuman in some European countries, and not the recombinant product, was the subject of leakage problems in Europe. The European Medicines Evaluation Agency said Feb. 14 that the recombinant Insuman Infusat cartridge system carries the same risk for leaks, although no cases have been reported. The semi-synthetic insulin product was approved through the decentralized EU procedure and the recombinant product was cleared through the EMEA centralized procedure
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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.’
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.
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.
