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French drugmaker Sanofi is looking to future-proof its diabetes franchise by in-licensing rights to a trio of next-generation diabetes medicines from South Korea’s Hanmi in a deal worth up to $4.2 billion. Read More
The European Commission released new guidelines clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect. Read More
Starting next June, drugmakers must use a new centralized database to file product safety update reports, the European Medicines Agency says. Read More
Manufacturers of new biologics could receive up to eight years of exclusivity in 12 countries under the Trans Pacific Partnership, a close reading of the deal shows. The specific terms of the contentious trade pact, which President Barack Obama inked with 11 other countries in October, were publicly released Nov. 6. Read More
The FDA has approved AstraZeneca’s metastatic non-small cell lung cancer drug Tagrisso in a first-of-its-kind indication targeting patients with the EGFR T790M mutation. Read More
It was a big day for Baxalta’s hemophilia franchise on Friday, with the company announcing that it had nabbed marketing authorization in the EU for Obizur, and the FDA giving its approval for Adynovate. Read More
A Merck subsidiary could lose patent protection on the popular antibiotic Cubicin next year, after a federal appellate court invalidated four of the company’s five patents on the drug. Read More