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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • newExclusive: First gene therapy drug sets million-euro price record
      By Ludwig Burger and Ben Hirschler FRANKFURT/LONDON (Reuters) - The Western world's first gene therapy drug is set to go on sale in Germany with a 1.1 million euro ($1.4 million) price tag, a new record for a medicine to treat a rare disease. The sky…
      - 16 hours ago, 26 Nov 14, 5:52pm -
    • With gene mutations, second breast cancer risk rises over time
      By Kathryn Doyle (Reuters Health) – Women who are genetically susceptible to breast cancer and develop it in one breast are at higher than average risk for a tumor in the other breast, and that risk may increase as time goes on, according to a new…
      - 6 days ago, 20 Nov 14, 11:41pm -
    • Surrogate sushi: Japan biotech for bluefin tuna
      TATEYAMA, Japan (AP) — Of all the overfished fish in the seas, luscious, fatty bluefin tuna are among the most threatened. Marine scientist Goro Yamazaki, who is known in this seaside community as "Young Mr. Fish," is working to ensure the species…
      - 7 days ago, 20 Nov 14, 7:07am -
    • Gene therapy found effective in hemophilia B
      By Gene Emery (Reuters Health) - Ten patients with severe hemophilia B have remained cured of the inherited bleeding disorder for as long as three years thanks to gene therapy, according to a new report on the technique in the New England Journal of…
      - 8 days ago, 19 Nov 14, 10:01pm -
    • Study suggests genetic link for male homosexuality
      CHICAGO (AP) — A large study of gay brothers adds to evidence that genes influence men's chances of being homosexual, but the results aren't strong enough to prove it.
      - 10 days ago, 17 Nov 14, 2:22pm -
    • Puma Biotech says cancer drug fails mid-stage study
      (Reuters) - Puma Biotechnology Inc said its cancer drug failed as a primary treatment for breast cancer patients in a mid-stage study, sending its shares down 14 percent in extended trading. The company said the drug, neratinib, did not significantly…
      - 13 days ago, 13 Nov 14, 10:31pm -
    • Gene study boosts interest in heart drug Zetia
      Scientists have discovered gene mutations that give people naturally lower cholesterol levels and cut their risk of heart disease in half.
      - 14 days ago, 12 Nov 14, 10:31pm -
    • World's oldest people share no genetic secrets
      US scientists said Wednesday they've found no genetic secrets shared between a group of 17 supercentenarians, or those who have lived beyond 110. "From this small sample size, the researchers were unable to find rare protein-altering variants signifi…
      - 14 days ago, 12 Nov 14, 10:31pm -
    • U.S. gene study raises hope for Merck cholesterol drug Zetia
      By Julie Steenhuysen CHICAGO (Reuters) - Rare mutations in a single gene may help lower cholesterol and reduce the risk of a heart attack by half, U.S. researchers said on Wednesday in a study that could have implications for Merck and Co's closely w…
      - 15 days ago, 12 Nov 14, 10:02pm -
    • Sanofi's dual-action biotech asthma drug performs well in test
      (Reuters) - An experimental biotech drug for moderate to severe asthma from France's Sanofi and its U.S. partner Regeneron has produced good results in clinical tests, suggesting that its dual-action mechanism may be highly effective. The encouraging…
      - 16 days ago, 11 Nov 14, 9:58am -

    Regulatory Affairs Pharma

    BIO - Press

    Eye On FDA

    • 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 →
      - 14 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 →
      - 20 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…
      - 22 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 →
      - 34 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 →
      - 37 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 →
      - 40 days ago, 18 Oct 14, 3:26pm -
    • AdComms for Last Quarter of 2014
      It is hard to believe it, but we have entered the final quarter of 2014.  I thought it a good time to revisit the upcoming AdComm schedule for those AdComm meetings that affect drugs or devices. Prior postings that provided … Continue reading →
      - 43 days ago, 15 Oct 14, 9:56am -
    • Weekly Roundup 10.3.14
      Back from a brief vacay to discover that leaves are littering the yard and porch as if it were autumn and then realizing that it is, in fact, autumn.  The year is going by so quickly and there is so … Continue reading →
      - 55 days ago, 3 Oct 14, 2:50pm -
    • Less Characters, More Tweets – A Few Tweeting Tips
      It is hard to believe that a service that limits your speech to 140 characters would emerge as an important media platform, but it has.  News travels more quickly, is more granular in nature, can very specific to highly targeted … Continue reading…
      - 56 days ago, 2 Oct 14, 1:49pm -
    • Weekly Roundup 9.26.14
      I bring you the Weekly Roundup today from Cape Cod where there is a lovely sense of autumn in the air, but blue skies and lovely shoreline allowing us to still remember the summer’s most pleasant days. And here is … Continue reading →
      - 62 days ago, 26 Sep 14, 3:13pm -