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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • Fight over revolutionary genetic advance goes to court in US
      A fierce legal battle over the patent for a revolutionary gene-editing technique played out Tuesday in a US court, with billions of dollars at stake. In one corner of the fight are two women regularly considered possible candidates for a Nobel prize:…
      - 2 days ago, 7 Dec 16, 2:26am -
    • U.S. patent agency to weigh rival claims on gene-editing technology
      (Corrects company name to Editas Medicine from Editas Pharmaceuticals in paragraph 15) By Brendan Pierson (Reuters) - The U.S. patent agency on Tuesday will hear arguments in a heated dispute over who was first to invent a revolutionary gene-editing…
      - 2 days ago, 6 Dec 16, 4:16pm -
    • New Zealand man latest to claim Prince as father
      A New Zealand man is the latest person to say he is pop icon Prince's heir after a judge dismissed a series of other claims, court documents showed Monday. A lawyer for the administrator in charge of Prince's estate agreed to arrange genetic testing…
      - 3 days ago, 5 Dec 16, 9:53pm -
    • ReNeuron says stem cells improved motor function in stroke study
      (Reuters) - Biotechnology company ReNeuron Group Plc said its experimental stem cell therapy helped some patients improve motor functions in their arms in a mid-stage study after being disabled by stroke. Shares of the company jumped 22 percent to 3.…
      - 4 days ago, 5 Dec 16, 9:12am -
    • GSK biotech asthma drug wins UK approval after extra price cut
      GlaxoSmithKline's new injectable asthma drug Nucala has been recommended for use in Britain's state-run health service in the most severe patients, after the drugmaker provided further analyses on its use and made an additional price cut.
      - 8 days ago, 1 Dec 16, 12:14am -
    • UK experts give green light to 'three-parent babies'
      British scientists on Wednesday approved the use of so-called "three-parent baby" fertility treatments, paving the way for the country to become the first in the world to officially introduce the procedures. An independent panel of experts tasked wit…
      - 8 days ago, 30 Nov 16, 7:47pm -
    • Strict approvals needed for gene-edited crops: German minister
      The European Union should apply strict approval standards to new generations of gene-edited crops similar to those for genetically modified organisms (GMOs), Germany's junior environment minister said on Tuesday. Disease-resistant pigs and field crop…
      - 17 days ago, 22 Nov 16, 11:38am -
    • WADA says gene doping test will be used 'shortly' by labs
      GLASGOW, Scotland (AP) — The World Anti-Doping Agency says a gene doping test will be used "shortly" by accredited laboratories.
      - 18 days ago, 20 Nov 16, 9:54pm -
    • Janus portfolio manager sees more biotech gains on Trump
      Biotech stocks still have room to rise after the election of Donald Trump as U.S. president, which removed threats of drug price controls that had pushed shares to historically cheap levels this year, a top portfolio manager for Janus said on Wednesd…
      - 22 days ago, 16 Nov 16, 6:54pm -
    • Dimension Therapeutics reports 3Q loss
      On a per-share basis, the Cambridge, Massachusetts-based company said it had a loss of 58 cents. The gene therapy company posted revenue of $2.8 million in the period. The company's shares closed at $4.55. ...
      - 28 days ago, 11 Nov 16, 10:01am -

    Regulatory Affairs Pharma

    BIO - Press

      Eye On FDA

      • New Directions for FDA, Part 2 – Regulatory Matters
        In Part 1 about change facing FDA, we looked at the 21st Century Cures Act and some of the change that would be in store for FDA. But in this post-election cycle, there is more than pending legislation that could … Continue reading →
        - 7 days ago, 2 Dec 16, 1:06pm -
      • New Directions for FDA, Part 1 – 21st Century Cures
        One of the often stated priorities for lame-duck Congress has been voting on the 21st Century Cures Act. In a press release from Saturday, November 26 from the House Energy and Commerce Committee, the House is set to vote on … Continue reading →
        - 10 days ago, 29 Nov 16, 11:16am -
      • Local Ballot Initiatives Impacting Health and Healthcare
        There is a good deal of commentary about what happened at the nationally in this year’s election cycle. But a good deal happened at the state level as well – things that will impact healthcare and may influence how other … Continue reading →
        - 28 days ago, 10 Nov 16, 6:09pm -
      • FDA Seeking Even More Input on Character Space Limitation
        This week FDA published a notice in the Federal Register seeking comment on the proposed collection of information regarding research entitled “Character-Space-Limited Online Prescription Drug Communications“. The notice states that the objective…
        - 30 days ago, 9 Nov 16, 1:45pm -
      • Weekly Roundup 11.4.16
        We are almost through it!  Just a few more days. In the meantime, the more enjoyable aspects of autumn, chilly nights, fires in the fireplace, and brilliant leaves are all upon us. Soon the end of year holidays will be … Continue reading →
        - 35 days ago, 4 Nov 16, 10:21am -
      • Weekly Roundup 10.28.16
        It has been way too long since a Weekly Roundup and way too long since a regular posting. The autumn has turned out to be an exceptionally busy time so apologies on both fronts. But today I’m carving out a … Continue reading →
        - 42 days ago, 28 Oct 16, 1:33pm -
      • Weekly Roundup 9.30.16
        The shifting of gears is happening before our eyes. Already leaves are falling and the morning alarm goes off in the final moments of night time darkness rather than the first rays of morning sunshine. The trees are signalling that … Continue readi…
        - 70 days ago, 30 Sep 16, 12:08pm -
      • Breakthrough Therapy Status, AdComms and Approvals
        In recent years FDA has undertaken several means to facilitate the consideration of new drug applications by creating various mechanisms for expedited review for either new drugs or new indications for existing drugs. Prior to 2012, there had long be…
        - 77 days ago, 23 Sep 16, 11:33am -
      • Weekly Roundup 9.16.16
        Kids are back in school. The air is kinder, gentler and less harsh than the last heated days of summer, though summer tries to hang on some days, it is ebbing into Autumn. Halloween candy has already appeared in stores. … Continue reading →
        - 83 days ago, 16 Sep 16, 3:11pm -
      • Weekly Roundup 9-2-16
        The end of summer. This is less like a Weekly Roundup than a Monthly Roundup. Like everyone else, I have taken August with a grain of salt. It feels a little lonely writing blog postings when you know that readers … Continue reading →
        - 98 days ago, 2 Sep 16, 12:35pm -