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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • newGene clues to glaucoma risk
      Scientists on Sunday said they had identified six genetic variants linked to glaucoma, a discovery that should help earlier diagnosis and better treatment for this often-debilitating eye disease. The flaws came to light in a minute trawl through the…
      - 23 hours ago, 31 Aug 14, 7:32pm -
    • Gene studies of Ebola in Sierra Leone show virus is mutating fast
      By Julie Steenhuysen CHICAGO (Reuters)- Genetic studies of some of the earliest Ebola cases in Sierra Leone reveal more than 300 genetic changes in the virus as it leapt from person to person, changes that could blunt the effectiveness of diagnostic…
      - 3 days ago, 29 Aug 14, 10:34am -
    • Japan lab unable to replicate stem cell results
      TOKYO (AP) — The Japanese laboratory that retracted a paper reporting a potentially major breakthrough in stem cell research said Wednesday its researchers have not managed to replicate the results.
      - 5 days ago, 27 Aug 14, 2:12pm -
    • Japan lab unable to replicate 'stem cell' findings
      Researchers in Japan said Wednesday they have been unable to replicate experiments that were hailed earlier this year as a "game-changer" in the quest to grow transplant tissue, amid claims evidence was faked. In a scandal that rocked Japan's scienti…
      - 5 days ago, 27 Aug 14, 8:35am -
    • Japan lab unable to replicate 'stem cell' findings: report
      Researchers in Japan have been unable to replicate experiments that were hailed earlier this year as a "game-changer" in the quest to grow transplant tissue, amid claims evidence was faked, a report said Wednesday. In a scandal that rocked Japan's sc…
      - 6 days ago, 27 Aug 14, 6:15am -
    • Biotech firm's GM mosquitoes to fight dengue in Brazil
      It's a dry winter day in southeast Brazil, but a steamy tropical summer reigns inside the labs at Oxitec, where workers are making an unusual product: genetically modified mosquitoes to fight dengue fever. The British biotech firm has altered the DNA…
      - 6 days ago, 27 Aug 14, 3:44am -
    • U.S. court overturns law limiting biotech crops on Hawaiian island
      A group of global biotech crop companies won a court victory on Monday that blocks enactment of a law passed last year limiting the planting of biotech crops and use of pesticides on the Hawaiian island of Kauai. District Court in Hawaii ruled that t…
      - 7 days ago, 25 Aug 14, 9:44pm -
    • No biotech copycat drug lift off before 2017: Novartis CEO
      Swiss drugmaker Novartis AG does not expect copycat versions of biotech drugs to play an important role in the healthcare system for another three to five years, its chief executive said on Monday. Novartis' generics unit Sandoz is the No. 1 player i…
      - 7 days ago, 25 Aug 14, 4:58pm -
    • Roche to buy U.S. biotech firm InterMune for $8.3 billion
      By Ben Hirschler and Caroline Copley LONDON/ZURICH (Reuters) - Roche Holding AG has agreed to buy U.S. Roche's efforts to produce successful non-cancer drugs from its own labs have been mixed, with setbacks in recent years for experimental drugs agai…
      - 7 days ago, 25 Aug 14, 8:31am -
    • Roche to buy US biotech firm InterMune for $8.3B
      BERLIN (AP) — Swiss pharmaceutical company Roche said Sunday it has reached an $8.3 billion deal to buy InterMune Inc., a California-based developer of treatments for lung diseases.
      - 8 days ago, 24 Aug 14, 5:19pm -

    Regulatory Affairs Pharma

    BIO - Press

    Eye On FDA

    • Weekly Roundup 8.22.14
      For the past few years here in Washington, the summer ended in August seemingly with the flip of a switch following Labor Day Weekend.  The daily threat of storms abated, the high humidity retreated, air conditioners were switched off in … Continu…
      - 10 days ago, 22 Aug 14, 1:16pm -
    • DTC and Regulatory Enforcement
      FDA’s OPDP views nearly all industry communication – whatever the venue and intent – through a lens of advertising.  Certainly a big focus of regulatory enforcement has been direct-to-consumer advertising and for a long time, there has been gu…
      - 11 days ago, 21 Aug 14, 9:57am -
    • Cloudy Forecast on Sunshine Act Data Release?
      In June I put on a Webinar about the communications impact and considerations respecting the upcoming release of data from CMS under the terms of the Sunshine Act. That followed a blog posting from April. The point in both of … Continue reading →
      - 13 days ago, 19 Aug 14, 10:00am -
    • Weekly Roundup 8.15.14
      It is hard to believe that I see on Facebook many of my friends who are parents  talking about their kids headed back to school this week.  Back to school?  Back to school? Why when I was a lad, which … Continue reading →
      - 17 days ago, 15 Aug 14, 1:38pm -
    • Weekly Roundup 8.7.14
      August is supposed to be slow.  And lazy.  Laying around doing nothing.  That is what Marky the Cow is doing in this picture.  (For those of you who are new to Eye on FDA, Marky is a dairy cow in … Continue reading →
      - 24 days ago, 8 Aug 14, 2:28pm -
    • To Tweet or Not to Tweet? Or Even Retweet? FDA, Tweeting and Twitter
      On June 27, FDA approved a new product – a rapid acting inhaled insulin indicated for the treatment of diabetes call Afrezza.  The agency announced the approval by sending out a press release.  The agency also sent out this tweet: … Continue re…
      - 32 days ago, 31 Jul 14, 11:09am -
    • Upcoming AdComms By Subject Matter
      In February and in April I posted a listing of upcoming advisory committees by subject matter and people seemed to like this way of looking at it, so I try to repeat it every so often.  Today is every so … Continue reading →
      - 35 days ago, 28 Jul 14, 3:14pm -
    • Weekly Roundup 7.25.14
      We sit on the cusp of August – the month when America goes on vacation.  Everything will slow down, rush hour will be less rushed, lawns will need less cutting and in our sights is Labor Day which brings the … Continue reading →
      - 38 days ago, 25 Jul 14, 5:02pm -
    • Developing a Policy for Correcting Third Party Misinformation
      Last week I held my Webinar on FDA’s Regulation of Social Media called “In More than 140 Characters…”  During the 1 hour presentation, I attempted to cover a lot of ground, wanting not only to focus on the latest two … Continue reading →
      - 41 days ago, 22 Jul 14, 12:31pm -
    • Weekly Roundup 7.18.14
      Well, the “poor man’s polar vortex blew through and frankly, while it did make life overall more bearable.  But the dogs, the lawn and the flowers all seem happier so that makes it ok by me.  I also had my … Continue reading →
      - 45 days ago, 18 Jul 14, 1:55pm -