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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • newAstraZeneca bets on 'genetic scissors' for range of new drugs
      By Ben Hirschler LONDON (Reuters) - AstraZeneca said on Thursday it had struck four research agreements in the hot area of genome editing as it bets on a new "genetic scissors" technology to deliver better and more precise drugs for a range of diseas…
      - 11 hours ago, 29 Jan 15, 9:01am -
    • China university 'expels student over genetic blood disease'
      A student in Beijing is suing his university after he was allegedly expelled for having the rare hereditary blood disease haemophilia, reports said on Friday, the latest case in China's long history of medical discrimination. The student, identified…
      - 7 days ago, 23 Jan 15, 6:50am -
    • Scientists create 'genetic firewall' for new forms of life
      By Sharon Begley NEW YORK (Reuters) - A year after creating organisms that use a genetic code different from every other living thing, two teams of scientists have achieved another "synthetic biology" milestone: They created bacteria that cannot surv…
      - 8 days ago, 21 Jan 15, 6:02pm -
    • After Canada, UK, 23andMe wants DNA test growth abroad
      By Caroline Humer and Christina Farr SAN FRANCISCO (Reuters) - Silicon Valley-based genetic testing company 23andMe is looking for new growth of its direct-to-consumer DNA tests abroad, building on recent expansions into Canada and the UK. It is also…
      - 14 days ago, 15 Jan 15, 10:57pm -
    • Scientists find key gene mutations behind inherited heart disease
      By Kate Kelland LONDON (Reuters) - Scientists have identified the crucial genetic mutations that cause a common heart condition called dilated cardiomyopathy (DCM), paving the way for more accurate diagnosis and screening of high-risk patients. In a…
      - 15 days ago, 14 Jan 15, 7:01pm -
    • FDA panel endorses first lower-cost biotech drug
      WASHINGTON (AP) — Federal health experts have unanimously endorsed a Novartis drug which is expected to become the first lower-cost copy of a biotech drug to reach the U.S. market.
      - 22 days ago, 7 Jan 15, 9:48pm -
    • Novartis taps into gene editing for next generation drugs
      By Ben Hirschler LONDON (Reuters) - Novartis is diving deeper into the world of gene-based medicine by signing deals with two U.S. biotech companies, giving it access to a powerful new genome editing technology. The tie-ups with unlisted Intellia The…
      - 22 days ago, 7 Jan 15, 11:16am -
    • Israel's BrainStorm says stem cell drug benefits most patients in ALS trial
      TEL AVIV (Reuters) - Israel's BrainStorm Cell Therapeutics said final results from a clinical trial of its adult stem cell treatment in amyotrophic lateral sclerosis (ALS) were positive, with most patients showing a slowing in the disease's progressi…
      - 24 days ago, 5 Jan 15, 1:17pm -
    • Pharma and biotech on a roll as drug approvals hit 18-year high
      By Ben Hirschler LONDON (Reuters) - U.S. drug approvals in 2014 hit their highest level in 18 years and recommendations in Europe also came at a rapid rate, driven by expensive new treatments for cancer and rare diseases. After suffering a wave of pa…
      - 28 days ago, 1 Jan 15, 9:49am -
    • Top Japan lab dismisses ground-breaking stem cell study
      Japan's top research institute on Friday hammered the final nail in the coffin of what was once billed as a ground-breaking stem cell study, dismissing it as flawed and saying the work could have been fabricated. The revelations come a week after a y…
      - 35 days ago, 26 Dec 14, 6:26am -

    Regulatory Affairs Pharma

    BIO - Press

    Eye On FDA

    • Weekly Roundup 1.23.15
      It seems 2015 is moving even faster than 2014 as we prepare for the last week of January even though it feels as if the holidays were only last week. It has been that time of year for reflection, looking … Continue reading →
      - 6 days ago, 23 Jan 15, 5:14pm -
    • Review of Warning and Untitled Letters for 2014
      Earlier this month, I had posted about the steep decline in FDA’s OPDP enforcement rates as the number of Warning and Untitled letters for 2014 hit a new low of only ten for the year. In the posting, I had … Continue reading →
      - 8 days ago, 21 Jan 15, 4:07pm -
    • Weekly Roundup 1.16.15
      It is a three-day weekend! Granted we just had the holidays, but they are very filled with exhausting activity – decorating, receiving guests, being a guest, wrapping.  We need some recover time and in the spirit of the weekend, to … Continue re…
      - 13 days ago, 16 Jan 15, 4:24pm -
    • FDA Press Releases – 2014 What They Said and How They Said It
      Last year, Eye on FDA had a posting that examined the press releases of the previous year, relying on a new tracking system I had implemented for that purpose.  This being the second year of the database, we can not … Continue reading →
      - 16 days ago, 13 Jan 15, 3:28pm -
    • Weekly Roundup 1.9.15
      The New Year has gotten off to a very chilly start here in Washington, D.C. But we have a new Congress that has been sworn in as the 114th.  I have cleared the Eye on FDA tab on the blog … Continue reading →
      - 20 days ago, 9 Jan 15, 11:20am -
    • Warning and NOV Letters Plummet in 2014
      There are two types of letters issued by FDA’s Office of Prescription Drug Promotion (OPDP) related to its role in regulating the commercial speech of medical product manufacturers – Warning Letters (WLs) and Notice of Violation (NOV) letters. On…
      - 23 days ago, 6 Jan 15, 1:57pm -
    • Biggest 2014 FDA Stories
      Of course, it is entirely a subjective matter to pick out the most interesting stories of the year. When it comes to an agency that oversees the regulation of one-quarter of the U.S. economy spanning everything from medicines to cosmetics … Continu…
      - 24 days ago, 5 Jan 15, 11:28am -
    • Weekly Roundup 12.19.14

      - 41 days ago, 19 Dec 14, 1:49pm -
    • Weekly Roundup 12.12.14
      Christmas cards not addressed because they aren’t bought.  Gifts aren’t wrapped because of the same reason.  I am definitely naughty. FDA Expands Approval of Lilly’s Cyramza - The most common type of lung cancer, non-small cell lung cancer (N…
      - 48 days ago, 12 Dec 14, 10:34pm -
    • Weekly Roundup 12.5.14
      Time has been in short supply, but having survived Thanksgiving – guests, cooking and eating and gearing up for the gearing down of the calendar year (and the beginning of longer days) and it is time for a little breather. … Continue reading →
      - 55 days ago, 5 Dec 14, 10:51am -