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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