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Two patient advocacy groups are suing the FDA to force it to release raw clinical trial data on Gilead Sciences’ groundbreaking hepatitis C drugs Sovaldi and Harvoni. Read More
The European Medicines Agency Friday recommended under exceptional circumstances Alexion Pharmaceutical’s Strensiq for the long-term treatment of hypophosphatasia, a rare metabolic disorder that weakens bones. Read More
The UK’s healthcare costs regulator is asking Santen Pharmaceutical to provide more information on its Ikervis eye drops following a preliminary recommendation denying its use for the treatment of severe keratitis in adults with dry eye disease that didn’t improve with tear substitutes. Read More
More than a year after being rejected by the FDA, The Medicines Company’s intravenous antiplatelet drug Kengreal has received the go-ahead as a post-angioplasty anticlotting agent. Read More
Israeli drugmaker Teva will pay $24 million to settle a pay-for-delay lawsuit over its generic version of AstraZeneca’s heartburn relief drug Nexium. Read More