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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • newBroadway to honor director Gene Saks by dimming its lights
      NEW YORK (AP) — Broadway theaters plan to dim their marquee lights Wednesday night in memory of Gene Saks, the Tony Award-winning director of such plays as "Brighton Beach Memoirs" and "The Odd Couple."
      - 22 hours ago, 31 Mar 15, 3:07pm -
    • Tony winner and Neil Simon director Gene Saks dies at 93
      NEW YORK (AP) — Gene Saks, a prolific actor-director who teamed with playwright and fellow New Yorker Neil Simon on hit Broadway and movie productions of such Simon comedies as "The Odd Couple" and "Brighton Beach Memoirs," has died. He was 93.
      - 3 days ago, 29 Mar 15, 9:37pm -
    • U.S. biotech stocks may fall further as short interest rises
      A 4 percent decline in biotechnology stocks on Wednesday sent the Nasdaq Composite Index to its largest one-day loss in nearly a year, and some investors are betting that the once-hot sector has further to fall. Short interest has risen in a number o…
      - 5 days ago, 27 Mar 15, 5:09am -
    • Talk of biotech bubble rattles Wall Street
      The biotech sector is at the top of Wall Street's worry list as analysts debate whether high-flying pharma stocks are a bubble that is about to burst. Trade in biotech stocks was mixed Thursday as US stocks clawed back near even after early losses. B…
      - 6 days ago, 26 Mar 15, 11:03pm -
    • BioLineRX stem cell leukemia drug meets goals in early trial
      Israeli biopharmaceutical company BioLineRX Ltd said on Wednesday an early stage trial for a drug that uses stem cells to treat leukemia and other blood cancers met all safety and efficacy goals. Current stem cell treatments require four or five days…
      - 7 days ago, 25 Mar 15, 11:57am -
    • 'Genetic map' of Britain shows legacy of war, migration
      People who have long-term ancestry in Britain fall into 17 "genetically distinct" regional clusters, they found. "These researchers have been able to use modern genetic techniques to provide answers to the centuries-old question -- where we come from…
      - 14 days ago, 18 Mar 15, 9:39pm -
    • TV's Gene Gene the Dancing Machine dies
      PASADENA, Calif. (AP) — Eugene Patton, the stagehand who became "Gene Gene the Dancing Machine" on television's "The Gong Show" in the late 1970s, has died.
      - 14 days ago, 18 Mar 15, 7:19pm -
    • Gene Gene the Dancing Machine of 'Gong Show' fame dies
      (Reuters) - Eugene Patton, the stage hand who earned fame as "Gene Gene The Dancing Machine" on the quirky talent romp "The Gong Show," has died at the age of 82 after suffering from diabetes, his family said. At what were supposed to be spontaneous…
      - 17 days ago, 15 Mar 15, 5:03pm -
    • Xenon Pharmaceuticals posts 4Q profit
      The Burnaby, British Columbia-based company said it had profit of $1.57 per share. The gene therapy biotech company posted revenue of $4.4 million in the period. For the year, the company reported profit ...
      - 20 days ago, 12 Mar 15, 9:07pm -
    • Genetic test maker 23andMe launches drug R&D effort
      Google-backed genetic testing company 23andMe is launching its own drug development unit, betting that it can translate its database of customer DNA information into novel medicines. The Silicon Valley-based ...
      - 20 days ago, 12 Mar 15, 5:56pm -

    Regulatory Affairs Pharma

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    Eye On FDA

    • Weekly Roundup 3.27.15
      Another busy week – hence a day late with the Weekly Roundup. This week, I cleared one of the flower beds of the dead stems from winter and filled three lawn and leaf bags with leaves and stems.  They took … Continue reading →
      - 4 days ago, 28 Mar 15, 11:49am -
    • Is Bigger Safer? OPDP Enforcement Patterns and Company Size
      Eye on FDA has frequently carried overviews and summaries of enforcement by the Office of Prescription Drug Promotion (OPDP) through the issuance of Warning and Untitled Letters (regulatory action letters). These letters, along with guidance document…
      - 8 days ago, 24 Mar 15, 1:11pm -
    • Weekly Roundup 3.20.15
      There really is more to Eye on FDA than the Weekly Roundup, but this month you wouldn’t know it. Busy schedule combined with a few health issues have resulted in a diminished output, hopefully to be put right now that … Continue reading →
      - 12 days ago, 20 Mar 15, 1:58pm -
    • Weekly Roundup 3.13.15
      On the road this week left little time for posting, though some interesting things happened. And meanwhile, back in Washington, D.C., the last vestiges of snow have departed and on my dog walk, I spotted blooming purple crocuses which was … Continu…
      - 19 days ago, 13 Mar 15, 5:02pm -
    • Weekly Roundup 3.6.15
      I found myself dreaming about picking herbs from my herb garden and thinking of expanding my efforts there this year to include new items. I imagined flowers blooming out on back deck. And these whimsical thoughts all occurred while I … Continue re…
      - 26 days ago, 6 Mar 15, 2:29pm -
    • Communications in a Biosimilar Age Almost Upon Us
      When policy changes, communications must support the change by informing the stakeholders how it impacts them and the decisions they will have to make. When it comes to biosimilars, now is such a time. The question is – who does … Continue readin…
      - 27 days ago, 5 Mar 15, 11:40am -
    • Weekly Roundup 2.27.15
      Another round of snow this week, perhaps the last gasp of winter? I can’t say there is any hint of Spring in the air in these parts, but sure hope there is where you are. In any event, I am … Continue reading →
      - 33 days ago, 27 Feb 15, 9:02pm -
    • Legislative Proposals in the 114th Congress
      Every so often, EyeonFDA has an update for you on legislation that is proposed in the Congress that would impact the medical product marketplace if passed.  The new Congress has just two months old and while the last Congress was … Continue readin…
      - 35 days ago, 25 Feb 15, 2:58pm -
    • Weekly Roundup 2.20.15

      - 40 days ago, 20 Feb 15, 6:56pm -
    • The Language of Risk – FDA’s Evolution of Thought
      How does the average patient assess the risk of a medical product when deciding whether or not to seek it out? This month, FDA released a new draft guidance document entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk … Conti…
      - 41 days ago, 19 Feb 15, 2:30pm -