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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • newActor Gene Wilder, star of Mel Brooks movies, dies at 83
      Gene Wilder, the frizzy-haired actor who brought his deft comedic touch to such unforgettable roles as the neurotic accountant in "The Producers" and the mad scientist of "Young Frankenstein," ...
      - 13 mins ago, 29 Aug 16, 9:17pm -
    • newGene Wilder, star of 'Willy Wonka', 'Blazing Saddles', dead at 83
      By Piya Sinha-Roy LOS ANGELES (Reuters) - Gene Wilder, whose wild curls and startling blue eyes brought a frantic air to roles in the movies "Willy Wonka and the Chocolate Factory," "Young Frankenstein" and "Blazing Saddles," died on Monday at the ag…
      - 23 mins ago, 29 Aug 16, 9:07pm -
    • newMel Brooks, Gervais, more pay tribute to Gene Wilder
      LOS ANGELES (AP) — Tributes from peers and admirers poured in Monday for Gene Wilder, who died Sunday at the age of 83 of complications from Alzheimer's disease.
      - 34 mins ago, 29 Aug 16, 8:56pm -
    • new'Willy Wonka' star Gene Wilder dead at 83
      Gene Wilder, who delighted audiences with his comic turns in "Willy Wonka & the Chocolate Factory" and Mel Brooks classics including "Blazing Saddles" and "The Producers," died Monday at age 83. "It is with indescribable sadness and blues, but with s…
      - 49 mins ago, 29 Aug 16, 8:41pm -
    • newGene Wilder, star of 'Willy Wonka' and Mel Brooks comedies, is dead at 83, his family says
      Gene Wilder, the star of such comedy classics as “Young Frankenstein” and “Blazing Saddles,” has died. Wilder’s nephew said Monday that the actor and writer died late Sunday in Stamford, Connecticut from complications from Alzheimer’s dis…
      - 2 hours ago, 29 Aug 16, 7:19pm -
    • Gene Sauers takes 2-stroke lead in Boeing Classic
      SNOQUALMIE, Wash. (AP) — Gene Sauers took the Boeing Classic lead Saturday, two weeks after his breakthrough victory in the U.S. Senior Open.
      - 2 days ago, 28 Aug 16, 12:41am -
    • Gene Sauers, Kirk Triplett share Boeing Classic lead
      SNOQUALMIE, Wash. (AP) — U.S. Senior Open champion Gene Sauers eagled the par-5 18th hole Friday for a 7-under 65 and a share of the Boeing Classic lead with Kirk Triplett.
      - 3 days ago, 27 Aug 16, 3:37am -
    • Goodbye, herring? Biotech bait gives lobstermen alternative
      Lobster and crab fishermen have baited traps with dead herring for generations, but an effort to find a synthetic substitute for forage fish is nearing fruition just as the little fish are in short supply, ...
      - 3 days ago, 26 Aug 16, 2:43pm -
    • GM mustard clears hurdle in India but more remain
      By Mayank Bhardwaj and Krishna N. Das NEW DELHI (Reuters) - A government panel has cleared commercial use of what would be India's first genetically modified (GM) food crop, but politicians still have to give final approvals amid wide-spread public o…
      - 4 days ago, 25 Aug 16, 1:30pm -
    • Will Zika concerns override American fears over GMOs?
      The British company Oxitec has spent years creating a means for combatting mosquito-borne viruses, receiving a Federal Drug Administration clearance on Aug. 5, but uproar from Floridians led local officials to send the issue to a nonbinding referend…
      - 11 days ago, 18 Aug 16, 8:47pm -

    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.....
      - 62 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.....
      - 76 days ago, 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

      • 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…
        - 6 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…
        - 13 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 →
        - 31 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 →
        - 38 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 →
        - 48 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…
        - 52 days ago, 8 Jul 16, 12:25pm -
      • Pharma Twitter Activity
        I recall a time when the head of a regulatory department of a pharmaceutical company told me that the company would never, ever, ever under any circumstances be involved in social media. By my count, today that company has twenty-one … Continue rea…
        - 67 days ago, 23 Jun 16, 10:24am -
      • Weekly Roundup 6.17.16
        We are enjoying more respite from heat here in the mid-Atlantic. Certainly a difficult week that brought reflection and sadness for many. And so we’ll get right down to some of the things that happened FDA-related that were noteworthy: Tragedy ……
        - 73 days ago, 17 Jun 16, 11:53am -
      • Weekly Roundup 6.10.16
        We are finally getting some weather that could be described as delightful.  I hope that you are too. The grass is green, a breeze blows and there is lots of birdsong in the air. For the first time in years, … Continue reading →
        - 80 days ago, 10 Jun 16, 1:59pm -
      • Weekly Roundup 6.3.16
        Weekly Roundups have been in absentia for the past few weeks. Forgive me – it has not been for lack of wanting to get the job done, just time. May began with a serious bout of the flu. While it … Continue reading →
        - 86 days ago, 4 Jun 16, 12:06pm -