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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • GSK gets EU approval for first gene therapy for children
      The world's first life-saving gene therapy for children, developed by GlaxoSmithKline and Italian scientists, was approved for sale in Europe on Friday, in a step forward for the pioneering technology to fix faulty genes. Called Strimvelis, it is des…
      - 1 day ago, 27 May 16, 3:15pm -
    • From hardy pigs to super-crops, gene editing poses new EU dilemma
      It poses a thorny problem for European policymakers wary of new molecular manipulation in agriculture after a quarter century of conflict over genetically modified food. In a research lab in Norwich, 100 miles northeast of London, Wendy Harwood is ma…
      - 2 days ago, 26 May 16, 12:40pm -
    • Prince would-be heirs object to genetic testing
      Two people who say they are heirs to pop icon Prince have objected to a proposal by his estate to ask for genetic tests. Prince died on April 21 without a will and with no recognized children, leaving a giant question mark on an estate that could be…
      - 2 days ago, 26 May 16, 7:12am -
    • Biotech Regeneron replaces Intel as sponsor of Science Talent Search
      By Ransdell Pierson NEW YORK (Reuters) - Biotechnology company Regeneron Pharmaceuticals Inc on Thursday became the title sponsor of the most prestigious U.S. science competition for high school students, taking the baton from chipmaker Intel Corp. R…
      - 2 days ago, 26 May 16, 4:02am -
    • Israeli firms team up for high-speed 3D stem cell printing
      Israeli 3D printer firm Nano Dimension has successfully lab-tested a 3D bioprinter for stem cells, paving the way for the potential printing of large tissues and organs, the company said on Wednesday. While 3D printers are used already to create stem…
      - 3 days ago, 25 May 16, 3:13pm -
    • Prince estate claimants object to undergoing genetic testing
      CHASKA, Minn. (AP) — Two people claiming to be heirs of Prince's estate are objecting to having to take blood and genetic tests to prove their relationship to the musician.
      - 4 days ago, 24 May 16, 4:31pm -
    • Biotech firm to pay $3.5M fine to settle animal-abuse case
      One of the world's largest suppliers of antibodies used in research has agreed to pay a $3.5 million fine and cancel its research registration in order to settle government allegations that it mistreated ...
      - 7 days ago, 21 May 16, 10:27pm -
    • Myriad hit with complaint over access to genetic information
      The American Civil Liberties Union on Thursday filed a complaint with the federal government accusing genetic testing company Myriad Genetics Inc of refusing to provide four patients with personal genetic information they requested, though the compan…
      - 9 days ago, 19 May 16, 10:07pm -
    • More potential Prince heirs come forward
      Two more people came forward Wednesday as heirs to Prince as the administrator of the pop legend's estate laid out plans for genetic testing. The two new potential heirs both said they were descended from Prince's older half-brother Duane Nelson, who…
      - 10 days ago, 18 May 16, 10:34pm -
    • Icelandic gene study spots possible new way to cut heart risks
      A rare and previously unknown variation in some people's genes substantially reduces heart attack risk and cholesterol levels, potentially paving the way to new drugs, Icelandic researchers said on Wednesday. The missing 12 letters from a gene on chr…
      - 10 days ago, 18 May 16, 9:01pm -

    Regulatory Affairs Pharma

    BIO - Press

      Eye On FDA

      • The Drop in OPDP Enforcement
        Back when the Office of Prescription Drug Promotion (OPDP) issued regulatory action letters on a regular basis (either Warning Letters or Untitled Letters) regarding what the agency saw as infractions in the course of promotional speech, I would post…
        - 2 days ago, 26 May 16, 10:12am -
      • More Space on Twitter – Does it Change Things for Pharma?
        This week media carried reports that Twitter was going to making a shift in policy regarding space. Until now, you have been limited to 140 characters in your tweeting which included space for your – albeit tiny – URL and/or … Continue reading…
        - 10 days ago, 18 May 16, 1:48pm -
      • Which Way on the Public Health Narrative on Zika?
        Back in February in a post entitled “From HIV to Zika – The Role of Communications“, I listed several of the hallmark characteristics involving the communications environment and emerging pathogens, drawing not only on recent observations with…
        - 16 days ago, 12 May 16, 5:30pm -
      • Weekly Roundup 4.29.16
        Goodbye April. It was nice knowing you. There were a lot of noteworthy developments this week and I would like to write about them all, but as usual, will pick only a few from the bunch. FDA Issues Complete Response … Continue reading →
        - 29 days ago, 29 Apr 16, 10:35pm -
      • What Pharma’s Are Doing on Periscope – Update on the Landscape
        If you have Periscope on your phone, you may find yourself doing something and all of a sudden, hear a little whistle that is the sound cue to let you know that someone you follow has gone live. I set … Continue reading →
        - 30 days ago, 28 Apr 16, 6:11pm -
      • Weekly Roundup 4.22.16
        A few weeks ago it was snow, now it is pollen – laden everywhere. Dogs, cars, outdoor seating, all covered in a fine yellow haze. Or is that me? I have had such a busy week that the result has … Continue reading →
        - 36 days ago, 22 Apr 16, 11:41am -
      • Weekly Roundup 4.15.16
        It seems safe to say we are officially done with snow. Winter is finally at our backs. In the rear view mirror. Yes, we have shifted gears into that very, very short time of the spring – at least here … Continue reading →
        - 43 days ago, 15 Apr 16, 11:15am -
      • Serious Communications Planning Needed Now for Zika
        Election cycle aside, it is going to be a rough summer. As things stand, this will likely become the summer of Zika as the country faces a growing potential for dealing with transmission inside the U.S. and abroad.  As the … Continue reading →
        - 46 days ago, 12 Apr 16, 10:31am -
      • Weekly Roundup 4.8.16
        I put the herbs into the garden on a warm and balmy day last weekend only to fall victim to freeze warnings a day later so brought them in the house. Warms up. Put them back outside and then another … Continue reading →
        - 50 days ago, 8 Apr 16, 11:39am -
      • More or Less – FDA Press Releases 1st Quarter 2016
        There are going to be times when FDA has less to say than at other times. In fact, there have actually been times where the agency has gone weeks without issuing a press release about anything. This quarter was not … Continue reading →
        - 52 days ago, 6 Apr 16, 10:09am -