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US FDA accepts Sanofi and Regeneron’s dupilumab BLA for priority reviewThe US Food and Drug Administration (FDA) has granted priority review status to Sanofi and Regeneron’s biologics license application (BLA) for dupilumab to treat adult patients with inadequately contr2016/10/20
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EC grants marketing authorisation for Aptalis’s Truberzi to treat IBS-DThe European Commission (EC) has granted marketing authorisation for Aptalis’s Truberzi (eluxadoline) in Europe. Rights to the drug will shortly be transferred back to Allergan, following thesale of2016/10/19
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US FDA approves Janssen's Invokamet XR for type 2 diabetes treatment in adultsThe US Food and Drug Administration (FDA) has granted approval for Janssen Pharmaceuticals' Invokamet XR to treat type 2 diabetes in adults. Invokamet XR is a once-daily, fixed-dose combination thera2016/10/19
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EMA confirms safety of plasma and urine-derived medicines from Zika virus contaminationThe European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has confirmed that plasma or urine-derived medicines are safe for use in Europe. The agency confirmed that2016/10/18
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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