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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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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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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Spectrum Pharmaceuticals says FDA rejects its bladder cancer drug

18 November 2016 - Spectrum Pharmaceuticals said on Friday the U.S. FDA had rejected its bladder cancer treatment, apaziquone. ...

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U.S. FDA grants fast track designation for the development of Eisai's BACE inhibitor E2609 for early Alzheimer's disease

18 November 2016 - Eisai announced today that the U.S. FDA has granted fast track designation for the development of the ...

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FDA approves Intrarosa for postmenopausal women experiencing pain during sex

17 November 2016 - The U.S. FDA approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse ...

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Centrexion Therapeutics announces fast track designation granted by FDA to CNTX-4975 for treatment of Morton’s neuroma

15 November 2016 - CNTX-4975 has potential to be the first non-surgical FDA-approved treatment for orphan disease, painful foot nerve ...

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How drug price pressure helped sink Novo's insulin pill

16 November 2016 - Commercial rather than technical hurdles ultimately torpedoed Novo Nordisk's bid to make an oral form of ...

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How to make drug prices fair to U.S. consumers

16 November 2016 - Americans pay far more for branded prescription drugs than people in any other developed nation, exactly ...

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Trump used to rail against drug prices. Now the industry's allies are helping shape his agenda

15 November 2016 - President-elect Donald Trump made the cost of prescription drugs a central part of his healthcare pitch while ...

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AMA embraces value-based drug pricing

15 November 2016 - The US' largest physician organisation is supporting value-based pricing for medications. ...

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Study shows promise for expensive cholesterol drugs, but they are still hard to obtain

15 November 2016 - If there is one thing decades of studies with tens of thousands of heart disease patients ...

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