TKT Asks Judge To Limit Amgen's "30 Years" EPO Exclusivity As Trial Begins
Amgen's erythropoietin patents should not translate into 30 years of Epogen exclusivity, Transkaryotic Therapies said in opening arguments May 15 in Boston federal court.
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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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The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.
Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.
Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.