Roche Zenapax: FDA's Biological Response Modifiers Advisory Committee will review BLA for Zenapax (dacliximab) the morning of Oct. 17 for prophylaxis of acute rejection kidney transplant patients. In the afternoon, committee will consider Schering-Plough's Intron-A (interferon alfa-2b) for treatment of patients with high-tumor-burden follicular non-Hodgkin's lymphoma in conjunction with chemotherapy. Committee will meet at the Gaithersburg, Md. Holiday Inn at 8 a.m...
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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.’
Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.
EU marketing applications for drugs aimed at slowing myopia progression in children and for treating cutaneous T-cell lymphoma have been turned down by the European Medicines Agency.
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.
