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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • SEC charges former Puma Biotech employee with insider trading
      A former executive for biopharmaceutical company Puma Biotechnology Inc was charged on Thursday by the top U.S. securities regulator and prosecutors with trading on inside information ahead of a company announcement about its breast cancer drug. Robe…
      - 1 day ago, 29 Sep 16, 9:41pm -
    • Man's best friend? It may be genetic
      "Our findings suggest that there may be a common underlying genetic basis for social behaviour in dogs and humans," senior author Pers Jensen, a professor of ethology at Linkoping University in Sweden, told AFP. The first domesticated dogs -- some 15…
      - 1 day ago, 29 Sep 16, 6:21pm -
    • Amgen, Arrowhead team up on gene-therapies for heart disease
      Amgen Inc said on Thursday it would buy a stake in Arrowhead Pharmaceuticals Inc and collaborate with the company to develop gene-silencing therapies for heart disease. Arrowhead will get $35 million up front and a $21.5 million injection from Amgen…
      - 1 day ago, 29 Sep 16, 2:15pm -
    • NBTY to genetically test herbal supplements under NY accord
      By Jonathan Stempel NEW YORK (Reuters) - NBTY Inc, one of the largest U.S. herbal supplement producers, has agreed to conduct an advanced form of genetic testing to ensure that its herbal products contain what their labels say they contain, New York'…
      - 2 days ago, 28 Sep 16, 8:49pm -
    • Soccer-Vardy is a "genetic freak" like Bolt, says Leicester City scientist
      By Chris Bertram MANCHESTER, England Sept 28 (Reuters) - England striker Jamie Vardy is a "genetic freak" like nine-times Olympic sprint champion Usain Bolt, Leicester City's head of sport science Kevin Paxton said. Vardy enjoys an unorthodox lifesty…
      - 2 days ago, 28 Sep 16, 8:04pm -
    • FDA approves lower-cost alternative to biotech drug Humira
      Federal regulators on Friday approved the first alternative version of the second-best selling drug in the world, Humira, the blockbuster injection used to treat rheumatoid arthritis and other inflammatory ...
      - 7 days ago, 23 Sep 16, 10:22pm -
    • Breast cancer’s spread may be influenced by circadian gene
      By Lisa Rapaport (Reuters Health) - Variations in a gene involved in so-called circadian rhythms that control everything from cell division to sleep may also promote the spread of breast cancer to other organs, a new study suggests. In mouse studies,…
      - 8 days ago, 22 Sep 16, 9:23pm -
    • FTO gene not an obesity life sentence: study
      People who carry a variant in the so-called obesity gene, FTO, react just as well to diet and exercise as those without it, a research paper said Wednesday. "Individuals carrying the (variant) respond equally well to dietary, physical activity, or dr…
      - 10 days ago, 20 Sep 16, 10:47pm -
    • Just going on vacation may change gene activity
      By Kathryn Doyle (Reuters Health) - In a new study comparing a meditation retreat with just relaxing in the same locale, both options improved stress regulation, immune function and other cellular markers in the blood. For those who continued meditat…
      - 10 days ago, 20 Sep 16, 9:09pm -
    • GE brings off-the-shelf biotech drug factories to Ireland
      General Electric is digging deeper into biotechnology with plans to build four prefabricated drug factories in Ireland, bringing to Europe a low-cost manufacturing concept it first pioneered in China. The new factories on the site will be owned and r…
      - 12 days ago, 19 Sep 16, 11:10am -

    Regulatory Affairs Pharma

    • Regulator Reforms Coming Soon In Thailand?
      Thailand's public body TCELS (Thailand Center of Excellence for Life Sciences) and private companies are submitting proposals for the reform of the Thai FDA to make it more competitive with counterpart agencies in the region, notably the South.....
      - 94 days ago, 29 Jun 16, 8:20am -
    • No More Guessing On Device Scrutiny: EU Regulatory Texts now Out
      The consolidated texts of the EU's medical device regulation and IVD regulation are now publicly available on the website of the European Parliament, two weeks earlier than expected1. And the publication of the documents mean.....
      - 14 Jun 16, 9:50am -
    • US FDA Draft Guidance Tackles Medical Device 3-D Printing
      The US Food and Drug Administration has published a draft 'leapfrog' guidance on 3-D printing of medical devices that draws from a 2014 agency workshop on the topic1. The guidance outlines key issues manufacturers should think.....
      - 13 May 16, 8:50am -
    • How Medtech Can Avoid Becoming Stranded During EU Notified Body Redesignations
      Medical device manufacturers operating in Europe are facing the potential threat of finding themselves being without the necessary structures in place to continue displaying the CE marking on their products. There is a.....
      - 20 Apr 16, 5:50pm -
    • US FDA Brand Name Reviews: Predictability Returns To Process
      The US Food and Drug Administration's brand name review process appears to have settled into a more comfortable and predictable part of the new drug review process thanks to recently issued and updated guidance documents for .....
      - 20 Apr 16, 5:35pm -
    • India Bans 344 'Irrational' Fixed Dose Drugs; Next Round In Court
      The Indian government has banned 344 drugs - specifically, fixed dose combinations (FDCs) – on the ground that these products had "no therapeutic justification" and could pose risks to human health1. Some of the banned.....
      - 18 Mar 16, 9:05am -
    • EMA Survey To Gauge Pharma's Satisfaction With Its Medical Literature Monitoring Service
      The European Medicines Agency is inviting feedback from pharmaceutical companies using its medical literature monitoring service to gauge if they are satisfied with the operation of this new tool, which was created under the provisions of.....
      - 8 Mar 16, 11:28am -
    • GSK's Malaria Vaccine To Be Piloted In Sub-Saharan Africa
      GlaxoSmithKline's malaria vaccine, Mosquirix (RTS,S), is to be administered to young children in a limited number of African countries as part of a pilot scheme that could lead to wider deployment of the vaccine in three to five .....
      - 28 Oct 15, 5:29pm -
    • South Africa consults on device regulation proposals
      To the satisfaction of the local medtech industry, South Africa's government has moved relatively swiftly in taking the next step in the legislative process towards establishing a risk-based system of regulation for medical technology.....
      - 17 Aug 15, 12:35pm -
    • Into the future: a single EU body assessing relative effectiveness of medicines?
      A fully centralized European health technology assessment is probably not a possibility as member states individually are responsible for decisions on access to medicines via their respective national health systems. But what about a central EU.....
      - 16 Jun 15, 6:05pm -

    BIO - Press

      Eye On FDA

      • newWeekly Roundup 9.30.16
        The shifting of gears is happening before our eyes. Already leaves are falling and the morning alarm goes off in the final moments of night time darkness rather than the first rays of morning sunshine. The trees are signalling that … Continue readi…
        - 13 hours ago, 30 Sep 16, 12:08pm -
      • Breakthrough Therapy Status, AdComms and Approvals
        In recent years FDA has undertaken several means to facilitate the consideration of new drug applications by creating various mechanisms for expedited review for either new drugs or new indications for existing drugs. Prior to 2012, there had long be…
        - 8 days ago, 23 Sep 16, 11:33am -
      • Weekly Roundup 9.16.16
        Kids are back in school. The air is kinder, gentler and less harsh than the last heated days of summer, though summer tries to hang on some days, it is ebbing into Autumn. Halloween candy has already appeared in stores. … Continue reading →
        - 14 days ago, 16 Sep 16, 3:11pm -
      • Weekly Roundup 9-2-16
        The end of summer. This is less like a Weekly Roundup than a Monthly Roundup. Like everyone else, I have taken August with a grain of salt. It feels a little lonely writing blog postings when you know that readers … Continue reading →
        - 29 days ago, 2 Sep 16, 12:35pm -
      • This is Your State, This is Your State on Drugs
        I always enjoy doing a periodic check in on what states are doing when it comes to healthcare issues. Utilizing the excellent data base resources at the National Conference of State Legislatures, one can examine numerous categories of legislation tha…
        - 39 days ago, 23 Aug 16, 12:48pm -
      • AdComm Recommendations – How Often FDA Does Not Follow Them?
        When an FDA Advisory Committee meets and deliberates whether or not the new drug application put before the agency should or should not be approved, they gather together and deliberate in a public forum often for hours. Prior to the … Continue read…
        - 46 days ago, 16 Aug 16, 10:54am -
      • Weekly Roundup 7.29.16
        The lawn is a lovely shade of brown. What can one say after that? The hot, humid days always evoke for me very strong childhood memories when the days were long and the season far too short and time was … Continue reading →
        - 63 days ago, 29 Jul 16, 1:30pm -
      • Weekly Roundup 7.22.16
        Well, it is really hot. Really really hot. And I am moving kind of slow, as one should probably do in the summer. I didn’t even get to the Weekly Roundup last week, which means that some of what I … Continue reading →
        - 70 days ago, 22 Jul 16, 2:26pm -
      • More or Less – A Look at FDA Press Releases at Half Year
        What do FDA press releases for the year say about the rate of new approvals for 2016? Periodically I take a look at what FDA has said – and a little bit conversely at what it hasn’t. In April, I … Continue reading →
        - 81 days ago, 12 Jul 16, 10:22am -
      • Weekly Roundup 7.8.16
        Perhaps it is a throwback to childhood, but summer always seems to go by faster than other seasons. And this summer is no exception. Sunflowers are blooming, daisies are beaming, lawn mowers are mowing. It seems everywhere you look, summer … Contin…
        - 85 days ago, 8 Jul 16, 12:25pm -