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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • Hunt for HIV cure bolstered by new research
      A cure for HIV remains elusive, but scientists say the hunt is more hopeful than ever, based on the prospects of new research described at the International AIDS Society conference this week. Scientists reported on progress on gene therapy and using…
      - 9 days ago, 22 Jul 15, 2:33am -
    • Court ruling clears way for Novartis' low-cost biotech drug
      A federal appeals court has ruled that Novartis can begin selling its lower-cost copy of an Amgen Inc. drug in September, rejecting a bid to further delay the launch of the knock-off biotech medication. ...
      - 9 days ago, 21 Jul 15, 7:54pm -
    • Study claims stem cell advance for mitochondrial disease
      Scientists said Wednesday they had taken a key step towards stem cell therapy for rare mitochondrial disorders, passed on from mother to child. "This breakthrough... sets the stage for replacing diseased tissue in patients and opens the door to a wor…
      - 15 days ago, 15 Jul 15, 5:48pm -
    • Gene therapy for deafness moves a few steps closer
      By Ben Hirschler LONDON (Reuters) - Gene therapy for deafness is moving closer to reality, with new research on Wednesday showing the technique for fixing faulty DNA can improve responses in mice with genetic hearing loss. Separately, a clinical tria…
      - 22 days ago, 8 Jul 15, 6:04pm -
    • Scientists pinpoint gene for better rice
      "Rice is the key source of dietary calories for over half the world's population and a substantial improvement of yield potential will be required to feed a growing human population," Fu Xiangdong of the Chinese Academy of Sciences, a co-author of on…
      - 24 days ago, 6 Jul 15, 4:07pm -
    • For first time, gene therapy shows promise in cystic fibrosis
      By Kate Kelland LONDON (Reuters) - Scientists conducting a major trial of a therapy that replaces the faulty gene responsible for cystic fibrosis say the treatment has showed significant benefit for the first time in patients' lung function. The tech…
      - 28 days ago, 2 Jul 15, 11:03pm -
    • Gene therapy for cystic fibrosis promising for some patients
      LONDON (AP) — Doctors who gave children with cystic fibrosis a replacement copy of a defective gene say it appeared to slow the expected decline of some patients' lungs, but called the results "modest" and say there must be major improvements befor…
      - 28 days ago, 2 Jul 15, 10:42pm -
    • Connecticut to conduct DNA tests in deciding on retrying disabled man
      Connecticut prosecutors can conduct further genetic testing before deciding whether to retry a mentally disabled man who spent a quarter century in prison until his conviction for rape and murder was overturned, a judge ruled on Thursday. Although th…
      - 28 days ago, 2 Jul 15, 10:30pm -
    • Switzerland's Novartis buys US biotech firm Spinifex
      BERLIN (AP) — Swiss drug manufacturer Novartis says it is buying Spinifex Pharmaceuticals, a U.S.-based biotechnology company that specializes in developing treatments for chronic pain.
      - 31 days ago, 29 Jun 15, 8:04am -
    • Celladon says may liquidate; suspends gene therapy development
      (Reuters) - Drug developer Celladon Corp said on Friday it may liquidate itself if it were unable to find a buyer, and was suspending development of its gene therapy for heart failure. Celladon said if it were to liquidate during the third quarter en…
      - 34 days ago, 26 Jun 15, 12:16pm -

    Regulatory Affairs Pharma

    BIO - Press

    Eye On FDA

    • Weekly Roundup 7.24.15
      Greetings from Texas. Late with the Weekly Roundup here due to some serious travel obligations which are still underway and afford me very little in the way of access to the Internet. Apologies.  Had it been a low news-level week, … Continue readi…
      - 4 days ago, 26 Jul 15, 4:07pm -
    • FDA Press Releases – First Half of 2015
      As regular readers may remember, I have started a database that tracks FDA press releases that goes back through 2014 and provided an overview of the 2014 press releases (See – FDA Press Releases – What They Said and How … Continue reading →
      - 8 days ago, 22 Jul 15, 10:19am -
    • Weekly Roundup 7.17.15
      It was a wickedly busy week so apologies for the paucity of postings. We are over the half-way  mark for the year – if the year were represented by the days of the week, it would be Wednesday. Summer school … Continue reading →
      - 13 days ago, 18 Jul 15, 12:49am -
    • Weekly Roundup 7.10.15
      Here in the mid-Atlantic, we are experiencing daily rains. Not just rains. Biblical deluges. The gardens are happy. The dogs are not. Meanwhile, while FDA seems rather slow, there is news – breaking news even – and here is a … Continue reading…
      - 20 days ago, 10 Jul 15, 5:17pm -
    • A “Long Shot” at Getting FDA Off the Dime on Social Media
      Last month, Politico reported on the communications aspects of the 21st Century Cures Act (the Act) – also known as H.R. 6 – the sweeping legislation that addresses a range of issues related to medical research and access to medicines. … Contin…
      - 21 days ago, 9 Jul 15, 8:25pm -
    • FDA Enforcement of Digital Communications – An Update
      In 2013, I published a white paper called “FDA Communications Oversight in a Digital Era” that drew upon the data base I had put together of OPDP Warning and Untitled Letters (referred to collectively as “regulatory action letters”). The obje…
      - 35 days ago, 25 Jun 15, 4:44pm -
    • Weekly Roundup 6.19.15
      No postings this week – sorry about that – travel and business, but will shoot for some good ones next week. This was another week of tropical rain – the kind that comes and dumps steady water as if a … Continue reading →
      - 41 days ago, 19 Jun 15, 3:40pm -
    • Weekly Roundup 6.12.15
      It is as if the calendar just knows when to turn up the heat. We have crossed over into the second week of June and already we face days that head into the 90s and late afternoon thunderstorms that characterize … Continue reading →
      - 48 days ago, 12 Jun 15, 4:21pm -
    • Live Streaming – Game Changer for AdComms and Beyond?
      This week there was a lot of talk about last week and the meeting of the American Society of Clinical Oncology annual meeting ASCO 15, which was the 51st annual meeting of the society held May 29 – June 2 … Continue reading →
      - 49 days ago, 11 Jun 15, 10:45am -
    • Weekly Roundup 6.5.15
      It has been a week of rain and gloom in our nation’s seat of government. It has been cold, gray and unpleasant. Commutes are nasty. The lack of sunshine is getting serious. But on the bright side, pollen has been … Continue reading →
      - 55 days ago, 5 Jun 15, 3:27pm -