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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • newU.S. paves way for Novartis to copy Amgen biotech drug
      (Reuters) - U.S. regulators have accepted an application by Sandoz - the generics arm of Novartis - seeking approval for a copycat version of Amgen's drug Neupogen, or filgrastim, for patients with low white blood cell counts. The Food and Drug Admin…
      - 20 hours ago, 24 Jul 14, 10:26am -
    • Schizophrenia has many genetic links, study says
      By Andrew M. Seaman NEW YORK - More than 100 locations on the human genome may play a role in a person’s risk of developing schizophrenia, according to a new study. While the results do not have an immediate effect on those living with the psychiat…
      - 2 days ago, 22 Jul 14, 9:12pm -
    • Genetic mapping triggers new hope on schizophrenia
      WASHINGTON (AP) — Scientists have linked more than 100 spots in our DNA to the risk of developing schizophrenia, casting light on the mystery of what makes the disease tick.
      - 3 days ago, 22 Jul 14, 6:09am -
    • Genetic blueprint unveiled for vital food crop wheat
      By Will Dunham WASHINGTON (Reuters) - As far as agricultural genome research goes, this may be the best thing since sliced bread - wheat bread, that is. An international team of scientists on Thursday unveiled a genetic blueprint of wheat in an accom…
      - 7 days ago, 17 Jul 14, 9:52pm -
    • Top EU lawyer clears way to stem-cell patent ruling
      A human egg used to produce stem cells but unable to develop into a viable embryo can potentially be patented, a key EU legal chief said Thursday. In an opinion of huge interest for biotechnology companies investing in stem-cell research, Advocate Ge…
      - 7 days ago, 17 Jul 14, 9:40pm -
    • Scientists unlock genetic blueprint of wheat
      The genetic blueprint of wheat has been deciphered for the first time, a discovery that researchers said Thursday could lead to improved plant breeding and protection against disease and drought. Bread wheat is a leading staple for 30 percent of the…
      - 7 days ago, 17 Jul 14, 7:26pm -
    • Trying gene therapy to create biological pacemaker
      WASHINGTON (AP) — No batteries required: Scientists are creating a biological pacemaker by injecting a gene into the hearts of sick pigs that changed ordinary cardiac cells into a special kind that induces a steady heartbeat.
      - 8 days ago, 16 Jul 14, 11:55pm -
    • Injecting gene into heart muscle may replace pacemaker
      Injecting a certain gene into cardiac muscle has been shown in animal studies to help a weakened heart beat more strongly, scientists said Wednesday. "This development heralds a new era of gene therapy, where genes are used not only to correct a defi…
      - 8 days ago, 16 Jul 14, 10:34pm -
    • Gene therapy creates 'biological pacemaker' cells for the heart
      By Will Dunham WASHINGTON (Reuters) - Researchers have succeeded in turning ordinary cardiac muscle cells into specialized ones that deliver a steady heartbeat using a gene therapy procedure they predict could become an alternative to implanted elect…
      - 9 days ago, 16 Jul 14, 6:03pm -
    • American Gene Sauers soars to three-shot Senior Open lead
      (Reuters) - Diminutive Gene Sauers shrugged off a fever to outplay his better-known rivals and vault to a three-stroke lead after the third round at the U.S. Senior Open in steamy Edmond, Oklahoma on Saturday. Three years after surviving a mysterious…
      - 12 days ago, 13 Jul 14, 1:53am -

    Regulatory Affairs Pharma

    • US FDA India boss quits but collaborative focus appears intact
      The unexpected exit of Altaf Ahmed Lal from his position as director of the US Food and Drug Administration's office in India has left many questions unanswered, though there is optimism in the pharma industry that the agency's recent.....
      - 3 days ago, 21 Jul 14, 7:35pm -
    • More delays in EU for new medtech symbols standard as old standard reinstated
      The EU is facing more delays over the listing of the international medical devices symbols standard, EN ISO 15223-1-2012.It appears that more modifications are needed, and that these still need to be examined by the.....
      - 4 days ago, 21 Jul 14, 7:10am -
    • Dutch to ban permanent wrinkle fillers
      The Dutch government has drafted legislation to ban permanent wrinkle fillers in uses other than reconstructive purposes from 1 January next year. The use of permanent fillers would no longer be permitted in cosmetic surgery. The ban.....
      - 9 days ago, 16 Jul 14, 4:50pm -
    • Indian drug firms counter US 'bluff' on IPR regime
      Indian firms have launched a strong counter attack against Big Pharma's attempts to deride the country's intellectual property rights (IPR) regime and also thrown in an indirect challenge that they claim will call the US's 'bluff' on.....
      - 23 days ago, 2 Jul 14, 2:35pm -
    • EU medical device reform talks could start end of 2014/beginning of 2015
      The joint formal discussions that are needed for the proposed EU medical device and IVD regulations to proceed to the next stage could start by the end of this year or at the beginning of the next1.That is.....
      - 35 days ago, 20 Jun 14, 9:35am -
    • International software lifecycle processes standard moves closer to EU
      The definitive text of an updated international standard on medical device software - in particular software lifecycle processes - should be available in the EU within the next 18 months according to the European standards bodies,.....
      - 37 days ago, 18 Jun 14, 8:50am -
    • EU risk panel: expect breast implant rupture in lifetime; odds worse with PIP
      The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks has published an updated 95-page opinion on the safety of PIP silicone breast implants1.This is an update of.....
      - 63 days ago, 23 May 14, 6:20pm -
    • British man 'masterminded' GSK misconduct in China, officials claim
      Chinese police have named a British man as the suspected ringleader of alleged bribery claims against GlaxoSmithKline in the country, following a 10-month investigation. Mark Reilly is the former head of.....
      - 70 days ago, 16 May 14, 9:35am -
    • Ambiguities dot India's proposed SAE compensation norms
      India's proposed norms to determine the amount of compensation given in the case of clinical trial-related injury other than death appear to have a number of ambiguities including in areas concerning determining the exact extent of.....
      - 72 days ago, 14 May 14, 5:35pm -
    • US FDA dedicates team for EU 'mutual reliance' drug quality initiative
      The US Food and Drug Administration is establishing a dedicated team that will leverage the agency's relationship with the European Medicines Agency and other regulators in Europe to strengthen their reliance on each other for ensuring the.....
      - 73 days ago, 13 May 14, 3:05pm -

    BIO - Press

    Eye On FDA

    • Developing a Policy for Correcting Third Party Misinformation
      Last week I held my Webinar on FDA’s Regulation of Social Media called “In More than 140 Characters…”  During the 1 hour presentation, I attempted to cover a lot of ground, wanting not only to focus on the latest two … Continue reading →
      - 3 days ago, 22 Jul 14, 12:31pm -
    • Weekly Roundup 7.18.14
      Well, the “poor man’s polar vortex blew through and frankly, while it did make life overall more bearable.  But the dogs, the lawn and the flowers all seem happier so that makes it ok by me.  I also had my … Continue reading →
      - 7 days ago, 18 Jul 14, 1:55pm -
    • Collection of FDA and Social Media Resources
      Many years have passed since FDA began attempting to enunciate a regulatory approach to digital and social media – beginning in 2009 and still presumably on-going.  In June the most substantive guidance yet was released by the agency addressing tw…
      - 10 days ago, 15 Jul 14, 1:45pm -
    • Weekly Roundup 7.11.14
      As we head into the weekend after a busy week, with at least part of the country being informed about significantly cooler temperatures for next week being termed the “poor man’s polar vortex” of the summer – news, if not … Continue reading…
      - 14 days ago, 11 Jul 14, 3:24pm -
    • FDA Untitled Letter for a Sponsored Link and a Webinar: In More than 140 Characters: FDA’s Social Media Guidance – Past, Present and Future
      I crammed a lot into that title.  But here is the skinny.  A few weeks ago, FDA issued some new guidances around social media. This week, (yesterday) an untitled letter was posted about a sponsored link - the subject matter … Continue reading →
      - 16 days ago, 9 Jul 14, 1:18pm -
    • FDA Press Releases – What They Say – First Half 2014
      From time to time, I field questions centered around FDA press releases and what they say.  Every time I would have to go hunt and peck through years of releases to get an answer. Eventually I just put them into … Continue reading →
      - 17 days ago, 8 Jul 14, 1:46pm -
    • Weekly Roundup 7.4.14
      Happy Independence Day for America.  This week also so Canada Day.  So while a week where work productivity may have dipped, enjoyment factors probably drove up – at least in North America.  The season is marked by hot, humid days … Continue r…
      - 21 days ago, 4 Jul 14, 12:57pm -
    • Weekly Roundup 6.27.14
      Well, I am late again with the Weekly Roundup and I once again seek forgiveness. I didn’t even get much time to tweet!  It has been a rowdy few weeks and the summer is shaping up to be unruly.  We … Continue reading →
      - 27 days ago, 28 Jun 14, 12:02pm -
    • How a Watch Can Result in More OTC Switches
      Remember when your phone was just a phone?  You flipped it open and made a call.  It also may have told you the time, but you primarily used it for talking to people.  Today you actually use it in ways … Continue reading →
      - 29 days ago, 26 Jun 14, 12:54pm -
    • Guidance on Two Social Media Fronts from FDA’s OPDP
      For four and half years now FDA’s OPDP has endeavored to devise answers to 5 questions raised during a public hearing on the Internet, Social Media and Pharma and Device Manufacturers held in April 2009.  Finally, on a day when … Continue readin…
      - 37 days ago, 18 Jun 14, 4:17pm -