INTERNEURON REDUX PHASE IV ADVISORY COMMITTEE REVIEW expected for Nov. 22 to address issues for post-marketing studies of the weight loss agent. Redux (dexfenfluramine) was approved on April 29 for weight loss management in the treatment of obesity. The original approval included requirements for two types of post-approval studies: "a clinical pharmacokinetic fast/fed study" and a "clinical neuropsychological function study." Wyeth-Ayerst has said that the drug is generating "an average rate of 65,000 new prescriptions each week."
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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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Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.
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.
