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Sarepta Therapeutics receives FDA approval for Exondys 51 to treat DMDUS-based biopharmaceutical company Sarepta Therapeutics has secured the US Food and Drug Administration (FDA) accelerated approval for its Exondys 51 (eteplirsen) as a once-weekly intravenous infusion2016/10/18
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EMA grants positive opinion for Takeda’s NINLARO to treat multiple myeloma in adult patientsEuropean Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has givenapositive opinion recommending the conditional approval of Takeda Pharmaceutical's NINLAROTM (ixazomib)2016/10/17
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Mylan faces American anti-trust probe over EpiPen sales contractsMylan Pharmaceuticals has found itself in the centre of yet another controversy after the New York State Attorney General opened an antitrust investigation into the drug maker's practices over the sal2016/10/17
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Colombia makes good on Gleevec pricing threat with plans for 45% cutA tense, months-long pricing standoff with Novartis escalated late last week as Colombia decided to take the radical step it had been threatening: The country plans to cut the price of leukemia med Gl2016/10/14
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Sanofi lawsuit tries to hold Merck Lantus biosimilar at bayJust because Sanofi negotiated a settlement that allows Eli Lilly to launch its Lantus biosimilar injectorin mid-December does not mean the French drugmaker is prepared to cede U.S. market share to an2016/10/14
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Mylan CEO faces grilling on Capitol Hill as senators unveil price-hike legislationThe EpiPen drama is moving into a congressional hearing room. Mylan CEO Heather Bresch is on the docket to testify next Wednesday for the House Committee on Oversight and Government Reform, where she’2016/10/13
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Teva's trying to weasel out of its Mexican generics deal, new Rimsa lawsuit saysTurns out Teva didn’t quite know what it was getting itself into when it agreed to buy out Mexico’s Rimsa last year for $2.3 billion. The Israeli generics giant is suffering “buyer’s remorse” and loo2016/10/13
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After Grassley decries 'incomplete response,' Mylan agrees to pony up EpiPen docsCongress is starting to get some answers on EpiPen pricing. And though, so far, Mylan’s not offering much beyond what’s readily available via Google search, that could change later this week. The Hou2016/10/12
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Lundbeck pay-for-delay deals with Merck KGaA and others sized up by EU courtThe European Union's pushback on pay-for-delay arrangements among drugmakers is being tested today asits top court considers appeals from half a dozen drugmakers fined over deals with Denmark’s Lundbe2016/10/12
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Think EpiPen is Mylan's first scandal? Here's a timeline of jet use, an unearned MBA and moreMylan’s ($MYL) EpiPentornadois far from its first storm of controversy. It’s just the most mainstream. Over the past decade, its executives have caught fire for personal use of company aircraft, an un2016/10/11