Arog Pharmaceuticals receives FDA fast track designation for crenolanib for advanced gastro-intestinal stromal tumours with a D842V mutation in the PDGFRA gene

16 November 2016 - Arog Pharmaceuticals, today announced that the U.S. FDA has granted fast track designation for crenolanib for the ...

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Melinta Therapeutics submits Baxdela new drug application for hospital-treated skin infections

24 October 2016 - Melinta Therapeutics announced today that it has submitted new drug applications to the U.S. FDA for approval ...

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USA’s BIO slams Japan’s pharma reimbursement and pricing system

23 November 2016 - The US trade group the Biotechnology Innovation Organization, has declared its disappointment in Japan's price modification ...

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Eli Lilly’s experimental Alzheimer’s drug fails in large trial

23 November 2016 - An experimental Alzheimer’s drug that had previously appeared to show promise in slowing the deterioration of ...

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Sanofi receives FDA approval of Soliqua 100/33, for the treatment of adults with type 2 diabetes

21 November 2016 - Sanofi announced today that the U.S. FDA approved once-daily Soliqua 100/33 (insulin glargine & lixisenatide injection) ...

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High prices for some leukaemia drugs will make them less cost-effective

21 November 2016 - Pills used to treat a form of leukaemia may be more effective and convenient than chemotherapy, ...

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Mallinckrodt will initiate company-sponsored clinical trial of H.P. Acthar Gel in treatment of amyotropic lateral sclerosis

21 November 2016 - Investigational new drug application for use of H.P Acthar Gel in amyotropic lateral sclerosis awarded fast ...

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U.S. FDA grants fast track designation for the development of Oragenics’ AG013 for oral mucositis

21 November 2016 - Oragenics today announced that the U.S. FDA granted fast track designation to AG013, the Company’s lead ...

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Novo Nordisk receives US FDA approval for Xultophy 100/3.6

21 November 2016 - Novo Nordisk today announced that the US FDA has approved the new drug application for Xultophy 100/3.6.  ...

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Genmab announces U.S. FDA approval of Darzalex (daratumumab) for relapsed multiple myeloma

21 November 2016 - Darzalex (daratumumab) approved by U.S. FDA in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for ...

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Intarcia submits new drug application to FDA for U.S. marketing approval of ITCA 650 in type 2 diabetes

21 November 2016 - ITCA 650 is the first investigational drug to use Intarcia’s disruptive Medici Drug Delivery System to ...

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Regeneron CEO: A few ‘bad actors’ are raising drug prices for no reason

19 November 2016 - At an EY forum on Friday, the CEO of Regeneron Pharmaceuticals acknowledged that “really bad actors” ...

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Amgen eyes spending caps to win payer nods on migraine prospect erenumab

21 November 2016 - Note to drugmakers negotiating with payers: it’s not the price tag that’s the problem, or at ...

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Pfizer sues Texas health agency for releasing confidential pricing information

18 November 2016 - Pfizer has sued Texas' health agency, claiming it violated state and federal law by releasing the ...

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GSK files regulatory submission in US for once-daily closed triple combination therapy FF/UMEC/VI for patients with COPD

21 November 2016 - GSK and Innoviva today announced the filing by GSK of a regulatory submission with the US ...

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