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Pharma/Biotech/Devices

Pharmainfo.net - News

    FDA - Medical Device News

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    Yahoo! News - Biotechnolgy

    • newScientists to share real-time genetic data on deadly MERS, Ebola
      Genetic sequence data on two of the deadliest yet most poorly understood viruses are to be made available to researchers worldwide in real time as scientists seek to speed up understanding of Ebola and MERS infections. "The collective expertise of th…
      - 55 mins ago, 21 Apr 15, 12:11pm -
    • newIsrael's BrainStorm says stem cell drug benefits ALS patients
      Israel's BrainStorm Cell Therapeutics said a mid-stage clinical trial of its adult stem cell treatment showed a "statistically significant" effect in patients with amyotrophic lateral sclerosis (ALS). According to the ALS Association, 5,600 people in…
      - 3 hours ago, 21 Apr 15, 10:31am -
    • newQuest Diagnostics, French agency seek to expand breast cancer gene database
      Quest Diagnostics Inc, the world's largest provider of diagnostic testing services, is working with France's national health agency to build an expanded database for BRCA1 and BRCA2 gene mutations to better determine patient hereditary risks of breas…
      - 9 hours ago, 21 Apr 15, 4:15am -
    • Options market sees Celladon heart drug as all-or-nothing bet
      By Saqib Iqbal Ahmed NEW YORK (Reuters) - Celladon Corp's shares could either double in value or collapse over the next four weeks after the drug developer announces results from a heart failure gene therapy trial, options data shows. Later this mont…
      - 4 days ago, 17 Apr 15, 7:57pm -
    • ReNeuron stem cell therapy shows long-term promise for stroke
      A pioneering stem cell treatment for patients disabled by stroke has continued to show long-term promise in a clinical trial, the British biotech company behind the project said on Friday. News that two-year follow-up data from a small Phase I study…
      - 4 days ago, 17 Apr 15, 12:50pm -
    • Study questions accuracy of certain tumor-only gene mapping
      WASHINGTON (AP) — More cancer patients are getting the genes in their tumors mapped to help guide their treatment. New research suggests that isn't always accurate enough, and a second test could help ferret out the culprit genes.
      - 6 days ago, 15 Apr 15, 10:06pm -
    • Aetna, Cigna balk as Angelina effect spurs genetic cancer testing
      (This version of the April 12 story corrects reference to Dr. Daly's role in publishing recommendations for genetic testing in paragraph 18) By Caroline Humer NEW YORK (Reuters) - Medical researchers call it the "Angelina Effect," the surge in demand…
      - 7 days ago, 14 Apr 15, 8:29pm -
    • Venture capitalists ride biotech wave one drug at a time
      Just two, judging by the sale of XO1, a one-drug British firm snapped up last month by Johnson & Johnson. Ten years on from pioneering an ultra-lean business model focused on investing in "virtual" companies with a single experimental medicine, XO1's…
      - 11 days ago, 10 Apr 15, 12:42pm -
    • Genetic study finds severe inbreeding in mountain gorillas
      By Will Dunham WASHINGTON (Reuters) - The most extensive genetic analysis of mountain gorillas ever conducted has found the critically endangered apes burdened with severe inbreeding and at risk of extinction but the researchers still see reasons for…
      - 12 days ago, 9 Apr 15, 6:09pm -
    • Celladon to report results of its gene therapy for heart failure: CEO
      Celladon Corp expects to report this month results from a key trial of Mydicar, its experimental gene therapy for advanced heart failure, a condition in which the heart muscle cannot pump enough blood to meet the body's needs. On Monday, Bristol-Myer…
      - 13 days ago, 8 Apr 15, 8:40pm -

    Regulatory Affairs Pharma

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    Eye On FDA

    • Weekly Roundup 4.17.15
      A few weeks ago it snowed, this week the lawn mowers were revved up. The car is covered in pollen. The cherry trees in DC have peaked. The ranks of tourists have swollen. Taxes have all been done and filed … Continue reading →
      - 4 days ago, 17 Apr 15, 5:24pm -
    • Warning and NOV Letter Summary – 1st Quarter 2015
      In the years past when the Office of Prescription Drug Promotion (OPDP) issued Warning Letters (WL) and Notice of Violation (NOV) letters with regularity, it was the custom here at Eye on FDA to review them on a quarterly basis. … Continue reading…
      - 5 days ago, 16 Apr 15, 1:49pm -
    • Weekly Roundup 4.3.15
      March winds bring April showers. April showers bring May flowers.  May flowers bring pilgrims. Ha. It is April – 2015 speeds at a breath-taking speed. The yard work continues to wait, but the daffodils do not and have arrived in … Continue readi…
      - 18 days ago, 3 Apr 15, 5:34pm -
    • Weekly Roundup 3.27.15
      Another busy week – hence a day late with the Weekly Roundup. This week, I cleared one of the flower beds of the dead stems from winter and filled three lawn and leaf bags with leaves and stems.  They took … Continue reading →
      - 24 days ago, 28 Mar 15, 11:49am -
    • Is Bigger Safer? OPDP Enforcement Patterns and Company Size
      Eye on FDA has frequently carried overviews and summaries of enforcement by the Office of Prescription Drug Promotion (OPDP) through the issuance of Warning and Untitled Letters (regulatory action letters). These letters, along with guidance document…
      - 28 days ago, 24 Mar 15, 1:11pm -
    • Weekly Roundup 3.20.15
      There really is more to Eye on FDA than the Weekly Roundup, but this month you wouldn’t know it. Busy schedule combined with a few health issues have resulted in a diminished output, hopefully to be put right now that … Continue reading →
      - 32 days ago, 20 Mar 15, 1:58pm -
    • Weekly Roundup 3.13.15
      On the road this week left little time for posting, though some interesting things happened. And meanwhile, back in Washington, D.C., the last vestiges of snow have departed and on my dog walk, I spotted blooming purple crocuses which was … Continu…
      - 39 days ago, 13 Mar 15, 5:02pm -
    • Weekly Roundup 3.6.15
      I found myself dreaming about picking herbs from my herb garden and thinking of expanding my efforts there this year to include new items. I imagined flowers blooming out on back deck. And these whimsical thoughts all occurred while I … Continue re…
      - 46 days ago, 6 Mar 15, 2:29pm -
    • Communications 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…
      - 47 days 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 →
      - 53 days ago, 27 Feb 15, 9:02pm -