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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • Hockey legend Howe shows progress after stem cell treatment
      Detroit Red Wings legend Gordie Howe has made an "astonishing" recovery after receiving stem cell treatment earlier this month from a Mexico-based medical firm, the Howe family said. The 86-year-old Hall of Famer, who suffers from severe dementia, ha…
      - 3 days ago, 20 Dec 14, 4:06am -
    • Ice Hockey - Howe shows steady progress following stem cell treatment
      - Detroit Red Wings legend Gordie Howe has made an "astonishing" recovery after receiving stem cell treatments in early December from a Mexican medical company, the Howe family said Friday.
      - 3 days ago, 20 Dec 14, 3:19am -
    • Europe recommends approval for first stem-cell therapy
      LONDON (Reuters) - European regulators have recommended approval of the first medicine containing stem cells to treat a rare condition caused by burns to the eye. The European Medicines Agency said on Friday that Holoclar, from privately held Italian…
      - 3 days ago, 19 Dec 14, 1:08pm -
    • Japanese scientist resigns over stem cell scandal
      A researcher embroiled in a fabrication scandal that has rocked Japan's scientific establishment said Friday she would resign after failing to reproduce results of what was once billed as a ground-breaking study on stem cells. Haruko Obokata said she…
      - 3 days ago, 19 Dec 14, 7:58am -
    • Disgraced Japan researcher fails to replicate 'game changing' stem cell results
      By Elaine Lies TOKYO (Reuters) - A disgraced Japanese researcher has failed to replicate results hailed as a potential breakthrough in stem-cell treatment and efforts to do so will be abandoned, officials at her research institute said on Friday. The…
      - 3 days ago, 19 Dec 14, 4:23am -
    • Merck buys Swiss biotech with promising cancer drug
      KENILWORTH, N.J. (AP) — Drugmaker Merck says it's bought a Swiss biotech company developing cancer drugs as part of its strategy to be a top player in cancer, one of the hottest pharmaceutical research areas.
      - 4 days ago, 18 Dec 14, 5:16pm -
    • EU's top court opens door to some stem cell patents
      By Robert-Jan Bartunek and Ben Hirschler BRUSSELS/LONDON (Reuters) - Europe's top court has opened the door to certain stem cell patents in the European Union by ruling that an organism incapable of developing into a human being is not a human embryo…
      - 4 days ago, 18 Dec 14, 1:23pm -
    • U.S, China making progress on biotech crop talks: USDA's Vilsack
      CHICAGO (Reuters) - The United States and China are making progress in talks over Beijing's acceptance of new biotechnology for crops, U.S. Agriculture Secretary Tom Vilsack said on Wednesday. The countries are "moving toward an understanding of how…
      - 5 days ago, 17 Dec 14, 4:46pm -
    • Roche biotech unit submits skin cancer drug application to U.S. regulator
      ZURICH (Reuters) - Genentech, U.S. biotech unit of Swiss drugmaker Roche holding, said on Monday it had filed a marketing application to U.S. regulators for the use of its experimental drug in combination with another medicine to treat an advanced fo…
      - 7 days ago, 15 Dec 14, 7:06am -
    • Bluebird shares leap after gene therapy seen as cure for blood disorder
      (Reuters) - Shares of drug developer bluebird bio Inc shot up on Tuesday, after the company presented data that showed a cure for beta-thalassemia is within reach, prompting several brokerages to raise their price targets on the stock. The Cambridge,…
      - 13 days ago, 9 Dec 14, 4:06pm -

    Regulatory Affairs Pharma

    BIO - Press

    Eye On FDA

    • Weekly Roundup 12.19.14

      - 3 days ago, 19 Dec 14, 1:49pm -
    • Weekly Roundup 12.12.14
      Christmas cards not addressed because they aren’t bought.  Gifts aren’t wrapped because of the same reason.  I am definitely naughty. FDA Expands Approval of Lilly’s Cyramza - The most common type of lung cancer, non-small cell lung cancer (N…
      - 10 days ago, 12 Dec 14, 10:34pm -
    • Weekly Roundup 12.5.14
      Time has been in short supply, but having survived Thanksgiving – guests, cooking and eating and gearing up for the gearing down of the calendar year (and the beginning of longer days) and it is time for a little breather. … Continue reading →
      - 17 days ago, 5 Dec 14, 10:51am -
    • Freshman Healthbook
      We have just been through an election cycle and the 113th Congress is in lame duck session. We are about to move on to the new Congress in January 2015.  Who did America elect and what is their position on … Continue reading →
      - 20 days ago, 2 Dec 14, 7:08pm -
    • Upclose Look at Pharma and Twitter – A Brief Profile
      Last week I posted about the update to the database of pharma and social media use with respect to the increase in audience over last year.  While FDA’s OPDP was so complacent in coming forth in guidelines, the number of … Continue reading →
      - 39 days ago, 13 Nov 14, 5:49pm -
    • Weekly Roundup 11.7.14
      It is a lovely autumn in our nation’s capital – at least looking at the trees and the light.  It is always remarkable how the light angles change and the sun will suddenly appear beneath clouds instead of over them … Continue reading →
      - 45 days ago, 7 Nov 14, 9:05pm -
    • Pharma Twitter Followers on the Rise
      As a highly regulated industry, the pharmaceutical sector was very slow to embrace social media and given the very slow and highly restrictive guidance put out by FDA on that topic, branded participation – particularly on Twitter – is going … C…
      - 47 days ago, 5 Nov 14, 1:10pm -
    • Weekly Roundup – 10.24.14
      Autumn is well upon us.  Nature is showing us how diverse her color palette really is and it is always important to take some time and stop and enjoy it — sometimes hard to do when the demands of world … Continue reading →
      - 59 days ago, 24 Oct 14, 1:59pm -
    • Healthcare and the Election – Stateside Ballot Initiatives
      We are days away from the mid-term elections. Don’t worry, this isn’t another piece to read about how the Senate could hang in the balance for weeks; or how one party or another might retain or take control of any … Continue reading →
      - 62 days ago, 21 Oct 14, 3:12pm -
    • Weekly Roundup – 10.17.14
      Missed last week and sorry about that and this week’s roundup is a day late.  It has been a busy Fall and even yesterday was a travel day.  I can barely keep up with how quickly the year is passing. … Continue reading →
      - 65 days ago, 18 Oct 14, 3:26pm -