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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • newAduro Biotech reports 1Q loss
      The Berkeley, California-based company said it had a loss of 45 cents per share. The results fell short of Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research ...
      - 7 mins ago, 2 May 16, 9:09pm -
    • Sanofi, Medivation dig in for big biotech takeover battle
      By Matthias Blamont PARIS (Reuters) - Sanofi and its takeover target Medivation dug in for trench warfare on Friday, with the French drugmaker confident of winning over investors and the U.S. cancer firm insisting it was better off staying independen…
      - 3 days ago, 29 Apr 16, 2:13pm -
    • US biotech firm Medivation rejects Sanofi takeover bid
      US biotech company Medivation rejected an unsolicited $9.3 billion bid from French pharmaceuticals giant Sanofi Friday, saying the offer "substantially undervalues" the company. Medivation, which makes the lucrative prostate cancer drug Xtandi, said…
      - 3 days ago, 29 Apr 16, 1:44pm -
    • Younger than you look? Scientists identify gene nobody wants
      "For the first time, a gene has been found that explains in part why some people look older and others younger for their age," said researcher Manfred Kayser of Erasmus MC University Medical Center Rotterdam in the Netherlands.
      - 4 days ago, 28 Apr 16, 8:03pm -
    • AstraZeneca taps gene pioneer Venter for huge drug-hunting sweep
      By Ben Hirschler CAMBRIDGE, England (Reuters) - AstraZeneca, working with genome pioneer Craig Venter, is launching a massive gene hunt in the most comprehensive bet yet by a pharmaceutical firm on the potential of genetic variations to unlock routes…
      - 11 days ago, 21 Apr 16, 11:37pm -
    • Illumina shares tumble after revised revenue estimate
      Shares of Illumina Inc., which makes the genetic testing tools, lost nearly a quarter of their value Tuesday, a day after the company cut its first-quarter revenue estimate to $572 million due to lower ...
      - 13 days ago, 19 Apr 16, 8:22pm -
    • Gene Cryer, former editor of Sun Sentinel, dies at age 80
      FORT LAUDERDALE, Fla. (AP) — Gene Cryer, the former editor of what is now the South Florida Sun Sentinel, has died following complications from a stroke, the newspaper reported Saturday on its website.
      - 16 days ago, 16 Apr 16, 9:19pm -
    • Human genetic research with Chinese characteristics
      Chinese genetic scientists must not be put off sensitive research by ethical concerns, the team behind a controversial study on modified human embryos said Wednesday as debate erupted over the paper. Researchers from Guangzhou Medical University said…
      - 19 days ago, 13 Apr 16, 11:46am -
    • For some diseases, 'genetic destiny' can be averted: study
      Scientists said Monday they had found a handful of healthy people each carrying a genetic mutation that should have condemned them to crippling disease or death. Up to now, medical science assumed that anyone unlucky enough to have one of these so-ca…
      - 21 days ago, 11 Apr 16, 7:11pm -
    • Vericel stem cell heart failure therapy cuts deaths: study
      A stem cell therapy developed by Vericel Corp helped reduce deaths and hospitalizations in advanced heart failure patients, according to data from a midstage study, potentially providing a treatment that could delay the need for heart transplants. "P…
      - 28 days ago, 4 Apr 16, 5:34pm -

    Regulatory Affairs Pharma

    BIO - Press

      Eye On FDA

      • 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 →
        - 3 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 →
        - 4 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 →
        - 10 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 →
        - 17 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 →
        - 20 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 →
        - 24 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 →
        - 26 days ago, 6 Apr 16, 10:09am -
      • Weekly Roundup 4.1.16
        The year is now officially one-fourth done. We have a long, hot summer to slog through that will no doubt be followed by a tumultuous autumn election cycle, so it is perhaps best now to take time and enjoy the … Continue reading →
        - 31 days ago, 1 Apr 16, 11:27am -
      • Once and Future AdComms Affecting Drug Applications
        One area of FDA activity that I like to track is in relation to advisory committees which I think provide us with something of a surrogate marker for the pace at which FDA is considering and approving new drugs. To … Continue reading →
        - 33 days ago, 30 Mar 16, 10:23am -
      • Weekly Roundup 3.25.16
        Well the first quarter of 2016 has sure blown by. We had the earliest Equinox since the 19th Century. Someone flipped a switch and everything started blooming at once. The cherry blossoms got well underway this week. And here is … Continue reading…
        - 38 days ago, 25 Mar 16, 11:07am -