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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • newAvalanche Biotech reports 4Q loss
      The Menlo Park, California-based company said it had a loss of 46 cents per share. The results did not meet Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment ...
      - 3 hours ago, 5 Mar 15, 3:10pm -
    • newBiotech buys get pharma M&A off to flying start in 2015
      Competition for tomorrow's blockbuster drugs is now intense, inflating the cost of deals and pushing pharmaceuticals to center stage in overall mergers and acquisitions (M&A). So far this year, pharma deals have accounted for 10.5 percent of total M&…
      - 5 hours ago, 5 Mar 15, 1:31pm -
    • newArrowhead buys Novartis’ RNAi portfolio
      Arrowhead Research Corp said it acquired Novartis AG's RNAi assets to fortify its position in the field of gene therapy that aims to wipe out disease-causing proteins. The deal gives Arrowhead the freedom to operate in any target for any indication,…
      - 6 hours ago, 5 Mar 15, 12:36pm -
    • Puma Biotech reports 4Q loss
      On a per-share basis, the Los Angeles-based company said it had a loss of $1.57. Losses, adjusted for one-time gains and costs, were $1.03 per share. The results exceeded Wall Street expectations. The ...
      - 3 days ago, 2 Mar 15, 11:15pm -
    • Too many waiting for blood stem cell transplants
      Over a million people have received blood and marrow stem cell transplants for life-threatening diseases in the past 57 years, but too many are still waiting, a study said Friday. Haematopoietic stem cell transplantation (HSCT) often offers the only…
      - 7 days ago, 27 Feb 15, 12:13am -
    • AstraZeneca taps biotech firm Orca for autoimmune disease drugs
      LONDON (Reuters) - AstraZeneca has boosted its early-stage research in autoimmune disease by signing a three-year research deal with start-up firm Orca Pharmaceuticals, a small British biotech company formed in 2013, on a new class of drugs. Orca wil…
      - 8 days ago, 25 Feb 15, 7:23am -
    • Europe approves Western world's first stem-cell therapy for rare eye condition
      (Reuters) - Europe has approved the Western world's first medicine containing stem cells to treat a rare condition caused by burns to the eye, marking a milestone in the use of the technology. Holoclar, from privately held Italian company Chiesi, was…
      - 13 days ago, 20 Feb 15, 1:45pm -
    • U.S. FDA approves 23andMe's genetic screening test for rare disorder
      By Toni Clarke WASHINGTON (Reuters) - Google-backed 23andMe won U.S. approval on Thursday to market the first direct-to-consumer genetic test for a mutation that can cause children to inherit Bloom syndrome, a rare disorder that leads to short height…
      - 14 days ago, 20 Feb 15, 2:44am -
    • FDA eases access to DNA screening for inherited diseases
      WASHINGTON (AP) — Federal health officials are easing access to DNA tests used to screen parents for devastating genetic disorders that can be passed on to their children. The surprise announcement offers a path forward for Google-backed genetic te…
      - 14 days ago, 20 Feb 15, 1:44am -
    • Paying for gene therapy: are annuities the next big thing?
      By Deena Beasley LOS ANGELES (Reuters) - As U.S. drugmakers face growing resistance to the high price of cutting-edge treatments, a handful of companies are working on a new payment model that rewards them for the long-term performance of their medic…
      - 14 days ago, 19 Feb 15, 12:05pm -

    Regulatory Affairs Pharma

    BIO - Press

    Eye On FDA

    • newCommunications in a Biosimilar Age Almost Upon Us
      When policy changes, communications must support the change by informing the stakeholders how it impacts them and the decisions they will have to make. When it comes to biosimilars, now is such a time. The question is – who does … Continue readin…
      - 7 hours ago, 5 Mar 15, 11:40am -
    • Weekly Roundup 2.27.15
      Another round of snow this week, perhaps the last gasp of winter? I can’t say there is any hint of Spring in the air in these parts, but sure hope there is where you are. In any event, I am … Continue reading →
      - 6 days ago, 27 Feb 15, 9:02pm -
    • Legislative Proposals in the 114th Congress
      Every so often, EyeonFDA has an update for you on legislation that is proposed in the Congress that would impact the medical product marketplace if passed.  The new Congress has just two months old and while the last Congress was … Continue readin…
      - 8 days ago, 25 Feb 15, 2:58pm -
    • Weekly Roundup 2.20.15

      - 13 days ago, 20 Feb 15, 6:56pm -
    • The Language of Risk – FDA’s Evolution of Thought
      How does the average patient assess the risk of a medical product when deciding whether or not to seek it out? This month, FDA released a new draft guidance document entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk … Conti…
      - 14 days ago, 19 Feb 15, 2:30pm -
    • Weekly Roundup 2.13.15
      Happy Friday the 13th and the day before Valentine’s Day. It is cold.  There is fierce wind. Boston is due more snow. As if there aren’t enough reasons to dislike February…. For me the week flew by and I hope … Continue reading →
      - 20 days ago, 13 Feb 15, 4:15pm -
    • Eye on FDA’s 9th Birthday
      It is hard to believe, but today – February 9, 2015 – I have passed the ninth marker of Eye on FDA. It seems like only a short time ago that I was reading a friend’s excellent and humorous blog … Continue reading →
      - 24 days ago, 9 Feb 15, 11:21am -
    • Goodbye Dr. Hamburg
      In lieu of the Weekly Roundup this week, the report is dedicated to a sole development – the announcement by Dr. Margaret Hamburg of her departure from FDA after six years as FDA Commissioner. She leaves behind a number of … Continue reading →
      - 27 days ago, 6 Feb 15, 9:42pm -
    • How We Communicate Matters – Comparing Communications Vehicles and Regulatory Enforcement
      One of the benefits of tracking the regulatory actions of FDA through the Office of Prescription Drug Promotion (OPDP) is that it allows you to take the information and view it from different perspectives to look for interesting lessons and … Conti…
      - 28 days ago, 5 Feb 15, 11:12am -
    • FDA’s Novel Year of Novel Drug Approvals – 2014
      Of course it is more than a roll of the dice. A lot of work and effort goes into medical treatment applications for approval and into evaluating them for consideration. As was widely discussed in FDA-watching circles, the agency approved … Continue…
      - 30 days ago, 3 Feb 15, 11:33am -