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French drugmaker Sanofi is set to distribute large quantities of its new semisynthetic artemisinin malaria combination drug to six countries in which the mosquito-borne disease is endemic, a move that could address nearly one third of the global need. Read More
Generic versions of Depomed’s shingles drug Gralise are unlikely in the near future after a federal judge sided with the brand manufacturer’s patent infringement suit against a 2012 ANDA filed by Actavis. Read More
Gilead Sciences may continue marketing its blockbuster hepatitis C drug Sovaldi after winning a dispute with rival drugmaker Roche over rights to the expensive new therapy. Read More
The UK’s health cost-benefit agency has rejected Janssen’s prostate cancer drug Zytiga for use before chemotherapy, asserting it is unclear how much the therapy actually extends life, a decision the drugmaker plans to appeal. Read More
The FDA is mulling changes to the way it determines eligibility for 180-day generic exclusivity, including opening up the exclusivity decision-making process to the public, and it’s inviting industry to offer feedback on the idea. Read More
The FDA has approved Biogen Idec’s new multiple sclerosis treatment Plegridy, creating another opportunity for the drugmaker in the crowded MS market. Read More
Mylan and Sandoz have filed a legal brief with the U.S. Supreme Court challenging Teva’s appeal to salvage the patent protection on its blockbuster multiple sclerosis drug Copaxone. Read More
Sun Pharmaceutical recalled more than 450,000 drug units because the active ingredient wasn’t manufactured in compliance with FDA good manufacturing practices, creating another quality headache for the Indian drugmaker. Read More
The UK’s health cost-benefit watchdog put Gilead Sciences’ Sovaldi a step closer to winning National Health Service coverage, recommending the drug for the treatment of three types of hepatitis C infection. Read More
The FDA is asking Acura Pharmaceuticals to conduct an additional study to prove its abuse-deterrent painkiller can actually deter abuse, throwing a wrench into the small drugmaker’s plans for approval. Read More