Trump Administration prepares a drug pricing executive order, sources say

15 June 2017 - President may issue one order soon, plus a longer one later. ...

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FDA accepts Sandoz regulatory submission for a generic version of Advair Diskus

15 June 2017 - Sandoz believes its combination product will offer asthma and COPD patients same safety and efficacy as reference ...

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G.O.P. Senators might not realize it, but not one state supports the Republican Health Bill

14 June 2017 - It’s no secret that the American Health Care Act is unpopular. In recent national polls, only ...

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Institute for Clinical and Economic Review to evaluate voretigene neparvovec in upcoming review

15 June 2017 - First gene therapy to be submitted for approval to FDA; potential for life-time benefits with single ...

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Fostering medical innovation: a plan for digital health devices

15 June 2017 - It is incumbent upon FDA to ensure that we have the right policies in place to promote ...

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FDA grants breakthrough therapy designation to Omeros’ MASP-2 inhibitor OMS721 for the treatment of IgA nephropathy

13 June 2017 - Omeros’ second Phase 3 clinical program for OMS721 slated to begin this year. ...

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The remarkable steps Republicans are taking to obscure what’s in their health-care bill

13 June 2017 - News on Tuesday that on-camera interviews might be significantly curtailed within the Capitol is an on-the-nose ...

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Senate, White House working on drug pricing

14 June 2017 - On Tuesday, the Senate Health, Education, Labor and Pensions (HELP) Committee held the first of three ...

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How creative FDA regulation led to first-in-the-world approval of a cutting edge heart valve

14 June 2017 - Nearly six years ago FDA approved an artificial transcatheter heart valve to treat patients having severe ...

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Trump, in zigzag, calls House Republicans’ health bill ‘mean’

13 June 2017 - President Trump on Tuesday bluntly derided a House attempt to repeal the Affordable Care Act as ...

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Pfizer and Lilly receive FDA fast track designation for tanezumab

13 June 2017 - Global Phase 3 program is studying potential new treatment option for millions of people living with chronic ...

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Institute for Clinical and Economic Review’s “new evidence update” on PCKS9 inhibitors highlights lack of mortality benefit with evolocumab

13 June 2017 - Newly released clinical trial data show expected reductions in stroke and heart attack, but mortality benefit ...

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The halfhearted opposition to the G.O.P.’s health care misery

13 June 2017 - The Republican health care bill now sneaking its way through the Senate has a good chance ...

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In drug price hearing, Congress tries to answer some basic questions

13 June 2017 - Senate holds first of three hearings on the drug pricing. ...

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Government negotiation of prescription drug prices isn’t a panacea for lower costs

13 June 2017 - The Senate Committee on Health, Education, Labor, and Pensions is holding a hearing Tuesday on how ...

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