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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • Trinity Biotech reports 3Q loss
      On a per-share basis, the Bray, Ireland-based company said it had a loss of 2 cents. Earnings, adjusted for non-recurring costs, came to 7 cents per share. The medical diagnostic products developer posted ...
      - 1 day ago, 25 Oct 16, 1:01pm -
    • Burns adapting 'The Gene' book into PBS film
      NEW YORK (AP) — Ken Burns is getting back into medicine.
      - 6 days ago, 20 Oct 16, 5:04pm -
    • Swiss biotech company Roche posts 4 percent sales growth
      GENEVA (AP) — Swiss pharmaceuticals company Roche says strong growth in diagnostic products helped underpin a 4 percent rises in sales over the first nine months of 2016.
      - 6 days ago, 20 Oct 16, 8:56am -
    • Possible miscarriage gene found: study
      Scientists said Wednesday they had linked mutations in a specific gene with an increased risk of recurrent miscarriages, offering hopes of better diagnosis and treatment for affected women. The gene, dubbed FOXD1, was first pinpointed in lab mice, a…
      - 8 days ago, 18 Oct 16, 11:58pm -
    • Scientists grow mouse eggs from stem cells in lab
      Japanese scientists said Monday they had grown mouse eggs entirely in the lab, then fertilised them to yield fertile offspring, a scientific first cautiously hailed by experts in human reproduction. The technique -- which involved coaxing stem cells…
      - 9 days ago, 17 Oct 16, 7:25pm -
    • Perry joins board of firm where he had stem cell surgery
      AUSTIN, Texas (AP) — Former Texas Gov. Rick Perry has joined the board of a stem cell company where he underwent experimental back surgery before running for president in 2011 — a procedure that didn't calm the chronic pain that he later blamed f…
      - 13 days ago, 13 Oct 16, 11:07pm -
    • Lab-grown stem cells regenerate monkey hearts: study
      In a step forward for organ regeneration, stem cells grown from a single monkey's skin cells revitalised the damaged hearts of five sick macaques, scientists reported Monday. The experiment builds towards the goal of providing a vast and uncontrovers…
      - 16 days ago, 10 Oct 16, 3:31pm -
    • Fallen US biotech star Theranos to close test labs
      Theranos, a onetime star Silicon Valley startup focused on health technology, is closing its consumer blood-testing facilities amid its struggles with US regulators. "After many months spent assessing our strengths and addressing our weaknesses, we h…
      - 20 days ago, 6 Oct 16, 1:23pm -
    • SEC charges former Puma Biotech employee with insider trading
      A former executive for biopharmaceutical company Puma Biotechnology Inc was charged on Thursday by the top U.S. securities regulator and prosecutors with trading on inside information ahead of a company announcement about its breast cancer drug. Robe…
      - 27 days ago, 29 Sep 16, 9:41pm -
    • Man's best friend? It may be genetic
      "Our findings suggest that there may be a common underlying genetic basis for social behaviour in dogs and humans," senior author Pers Jensen, a professor of ethology at Linkoping University in Sweden, told AFP. The first domesticated dogs -- some 15…
      - 27 days ago, 29 Sep 16, 6:21pm -

    Regulatory Affairs Pharma

    BIO - Press

      Eye On FDA

      • 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…
        - 26 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…
        - 33 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 →
        - 40 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 →
        - 54 days ago, 2 Sep 16, 12:35pm -
      • This is Your State, This is Your State on Drugs
        I always enjoy doing a periodic check in on what states are doing when it comes to healthcare issues. Utilizing the excellent data base resources at the National Conference of State Legislatures, one can examine numerous categories of legislation tha…
        - 64 days ago, 23 Aug 16, 12:48pm -
      • AdComm Recommendations – How Often FDA Does Not Follow Them?
        When an FDA Advisory Committee meets and deliberates whether or not the new drug application put before the agency should or should not be approved, they gather together and deliberate in a public forum often for hours. Prior to the … Continue read…
        - 71 days ago, 16 Aug 16, 10:54am -
      • Weekly Roundup 7.29.16
        The lawn is a lovely shade of brown. What can one say after that? The hot, humid days always evoke for me very strong childhood memories when the days were long and the season far too short and time was … Continue reading →
        - 89 days ago, 29 Jul 16, 1:30pm -
      • Weekly Roundup 7.22.16
        Well, it is really hot. Really really hot. And I am moving kind of slow, as one should probably do in the summer. I didn’t even get to the Weekly Roundup last week, which means that some of what I … Continue reading →
        - 96 days ago, 22 Jul 16, 2:26pm -
      • More or Less – A Look at FDA Press Releases at Half Year
        What do FDA press releases for the year say about the rate of new approvals for 2016? Periodically I take a look at what FDA has said – and a little bit conversely at what it hasn’t. In April, I … Continue reading →
        - 12 Jul 16, 10:22am -
      • Weekly Roundup 7.8.16
        Perhaps it is a throwback to childhood, but summer always seems to go by faster than other seasons. And this summer is no exception. Sunflowers are blooming, daisies are beaming, lawn mowers are mowing. It seems everywhere you look, summer … Contin…
        - 8 Jul 16, 12:25pm -