Sandoz' acquisition of Canadian generic manufacturer Sabex will give the firm entry into the U.S. sterile injectable market, the company said June 7. The injectable medicines Infufer (iron dextran) and hydromorphone are Sabex' leading U.S. products. The company makes a total of 89 Canadian generic molecules in its FDA-approved facilities. The deal also allows Sandoz to bring its solid oral generics to the Canadian market. The $565 mil. cash transaction is expected to close in July. Sandoz plans to retain the entire Sabex management team...
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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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The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.