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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • FDA approves new drug for rare genetic disease
      WASHINGTON (AP) — The Food and Drug Administration on Tuesday approved a new capsule-based drug to treat Gaucher's disease.
      - 1 day ago, 19 Aug 14, 10:29pm -
    • Pfizer to help 23andMe unravel genetic ties to bowel disease
      Home genetics company 23andMe on Tuesday said it hopes to uncover gene mutations linked to inflammatory bowel disease (IBD) by enrolling 10,000 people with the hard-to-treat malady and examining DNA from their donated saliva samples. The privately he…
      - 8 days ago, 12 Aug 14, 5:59pm -
    • Briton with advanced heart failure launches new gene therapy trial
      A 37-year-old British man who needs a mechanical pump to keep his heart working has kicked off tests to see if gene therapy could help him recover and potentially avoid the need for a heart transplant. U.S. biotech firm Celladon hopes that its Mydica…
      - 10 days ago, 11 Aug 14, 12:21pm -
    • Study ties new gene to major breast cancer risk
      It's long been known that faulty BRCA genes greatly raise the risk for breast cancer. Now scientists say a more recently identified, less common gene can do the same.
      - 14 days ago, 7 Aug 14, 4:54am -
    • New breast cancer gene mutation found to raise risk
      A newly discovered gene mutation significantly raises a woman's risk of breast cancer and may be considered the third such inherited gene flaw known to science, researchers said Wednesday. Women with mutations in the PALB2 gene face a one in three ch…
      - 14 days ago, 6 Aug 14, 9:49pm -
    • Study finds a gene mutation increases breast cancer risk to 1 in 3
      By Kate Kelland LONDON (Reuters) - Women with mutations in a gene called PALB2 have a one in three chance of developing breast cancer by age 70, according to research that suggests PALB2 is almost as important a risk factor as BRCA1 or BRCA2 mutation…
      - 14 days ago, 6 Aug 14, 9:03pm -
    • Cytori halts stem cell study due to adverse events
      Cytori Therapeutics said Tuesday it has halted trials of its experimental stem cell therapy for heart failure after three patients developed blood flow problems. The San Diego-based company said it placed ...
      - 15 days ago, 5 Aug 14, 9:14pm -
    • Japan scientist in discredited stem-cell research dead in suicide
      Yoshiki Sasai, co-author of the high-profile research that had seemed to offer hope for replacing damaged cells or even growing new human organs, was found early on Tuesday at the Riken institute where he worked in Kobe, western Japan, police and the…
      - 16 days ago, 5 Aug 14, 10:16am -
    • Disgraced Japan stem cell scientist commits suicide
      A renowned Japanese stem cell scientist who co-wrote research that was later retracted in an embarrassing scandal has been found dead in an apparent suicide, police and officials said Tuesday. The body of Yoshiki Sasai, 52, was discovered hanging ins…
      - 16 days ago, 5 Aug 14, 7:04am -
    • Ebola therapy hopes shift to small California biotech
      Hopes of finding a treatment for the deadly Ebola virus shifted on Monday to a small California-based biotech company whose experimental drug has been used to treat two American missionary workers. The drug, developed by Mapp Biopharmaceutical Inc, w…
      - 16 days ago, 4 Aug 14, 10:56pm -

    Regulatory Affairs Pharma

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    Eye On FDA

    • Cloudy Forecast on Sunshine Act Data Release?
      In June I put on a Webinar about the communications impact and considerations respecting the upcoming release of data from CMS under the terms of the Sunshine Act. That followed a blog posting from April. The point in both of … Continue reading →
      - 2 days ago, 19 Aug 14, 10:00am -
    • Weekly Roundup 8.15.14
      It is hard to believe that I see on Facebook many of my friends who are parents  talking about their kids headed back to school this week.  Back to school?  Back to school? Why when I was a lad, which … Continue reading →
      - 6 days ago, 15 Aug 14, 1:38pm -
    • Weekly Roundup 8.7.14
      August is supposed to be slow.  And lazy.  Laying around doing nothing.  That is what Marky the Cow is doing in this picture.  (For those of you who are new to Eye on FDA, Marky is a dairy cow in … Continue reading →
      - 12 days ago, 8 Aug 14, 2:28pm -
    • To Tweet or Not to Tweet? Or Even Retweet? FDA, Tweeting and Twitter
      On June 27, FDA approved a new product – a rapid acting inhaled insulin indicated for the treatment of diabetes call Afrezza.  The agency announced the approval by sending out a press release.  The agency also sent out this tweet: … Continue re…
      - 21 days ago, 31 Jul 14, 11:09am -
    • Upcoming AdComms By Subject Matter
      In February and in April I posted a listing of upcoming advisory committees by subject matter and people seemed to like this way of looking at it, so I try to repeat it every so often.  Today is every so … Continue reading →
      - 23 days ago, 28 Jul 14, 3:14pm -
    • Weekly Roundup 7.25.14
      We sit on the cusp of August – the month when America goes on vacation.  Everything will slow down, rush hour will be less rushed, lawns will need less cutting and in our sights is Labor Day which brings the … Continue reading →
      - 26 days ago, 25 Jul 14, 5:02pm -
    • 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 →
      - 30 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 →
      - 34 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…
      - 37 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…
      - 40 days ago, 11 Jul 14, 3:24pm -