As political scrutiny mounts, Eli Lilly divulges new insulin pricing data

24 March 2019 - Lilly says the price it was paid for popular insulin Humalog fell 8.1% from 2014 to 2018 ...

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Drug prices on TV? They may be coming.

23 March 2019 - The Trump administration is moving ahead with its proposal to require drug companies to disclose the ...

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Drug company protections are latest stumbling block for NAFTA rewrite

21 March 2019 - President Trump’s ability to get his revised North American Free Trade Agreement through Congress may hinge ...

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FDA issues complete response letter for Zynquista (sotagliflozin)

22 March 2019 - The U.S. FDA issued a complete response letter regarding the New Drug Application for investigational Zynquista ...

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FDA takes new steps to advance natural history studies for accelerating novel treatments for rare diseases

22 March 2019 - The U.S. FDA today issued the draft guidance, Rare Diseases: Natural History Studies for Drug Development.  ...

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Recro Pharma receives complete response letter from the FDA for intravenous meloxicam

22 March 2019 - Recro Pharma today announced it has received a second complete response letter from the U.S. FDA Office ...

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Enzyvant's investigational Farber disease enzyme replacement therapy, RVT-801, receives FDA fast track and rare paediatric disease designations

21 March 2019 - Enzyvant today announced that the U.S. FDA has granted are paediatric disease and fast track designations for ...

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Promoting biosimilars up to health plans, manufacturers, doctors, Gottlieb says

21 March 2019 - As he wraps up his final weeks as commissioner of the FDA, Scott Gottlieb, MD, talked about ...

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FDA approves new device for treating moderate to severe chronic heart failure in patients

21 March 2019 - The U.S. FDA today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure ...

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AbbVie is sued for using Humira patent deals to block competition in the U.S.

20 March 2019 - In a novel step, a New York union accused AbbVie and seven other drug makers of ...

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Jazz Pharmaceuticals announces U.S. FDA approval of Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea

20 March 2019 - Sunosi is the first and only dual-acting dopamine and norepinephrine re-uptake inhibitor approved by the FDA to ...

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Biosimilar groups offer proposals to help US better mirror EU successes

19 March 2019 - With 18 biosimilars approved in the US and just seven on the market, two biosimilars groups ...

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Biosimilar approval and adoption in the U.S. needs to be expedited

20 March 2019 - Generic versions of brand-name small-molecule drugs saved Americans more than $1 trillion between 1999 and 2010. ...

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Iterum Therapeutics receives QIDP for oral and IV sulopenem in four additional indications as well as fast track designation

19 March 2019 - New designations in community-acquired bacterial pneumonia, acute bacterial prostatitis, gonococcal urethritis, and pelvic inflammatory disease demonstrate the ...

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Novo Nordisk files oral semaglutide for US regulatory approval of glycaemic control, as well as for CV risk reduction for oral semaglutide and Ozempic

20 March 2019 - Novo Nordisk today announced the submission of two new drug applications to the US FDA for ...

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