Generic paclitaxel
Los Angeles federal court order requiring Bristol-Myers Squibb to de-list a Taxol formulation patent from FDA's "Orange Book" will take effect Sept. 13 unless Bristol or American BioSciences, Inc. (the owner of the patent) can obtain a stay from the federal appeals court. Removal of the patent from the "Orange Book" would eliminate the last hurdle to the approval of Ivax' generic version of the anti-cancer agent. Ivax' paclitaxel ANDA was tentatively approved by FDA Aug. 28
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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.’
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An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.