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Sandoz wasted no time in launching its generic version of Copaxone in the U.S. after the U.S. Court of Appeals for the Federal Circuit again invalidated Teva’s patent on the blockbuster multiple sclerosis drug. Read More
Citing cost concerns, the UK’s healthcare watchdog is recommending against Celgene’s Otezla alone or in combination with disease-modifying antirheumatic drug therapies for adults with active psoriatic arthritis. Read More
The European Commission has approved Bristol-Myers Squibb’s Opdivo as both a first-line and second-line treatment for adults with advanced melanoma, allowing the drug to be marketed in all 28 member states. Read More
Aimmune Therapeutics has won FDA breakthrough therapy designation for AR101, an oral immunotherapy for children and adolescents with peanut allergies. Read More
The FDA and the European Medicines Agency are working to increase regulatory collaboration, including harmonizing their respective pharmacovigilance and quality by design programs, officials from both agencies said Thursday. Read More