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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • US scientists make embryonic stem cells from adult skin
      For the first time, US researchers have cloned embryonic stem cells from adult cells, a breakthrough on the path towards helping doctors treat a host of diseases. The embryonic stem cells -- which were created by fusing an adult skin cell with an egg…
      - 2 days ago, 18 Apr 14, 6:38pm -
    • In a cloning first, scientists create stem cells from adults
      By Sharon Begley NEW YORK (Reuters) - Scientists have moved a step closer to the goal of creating stem cells perfectly matched to a patient's DNA in order to treat diseases, they announced on Thursday, creating patient-specific cell lines out of the…
      - 3 days ago, 17 Apr 14, 10:36pm -
    • Japan confirms first bird flu case since 2011
      Two chickens have tested positive for avian influenza at a farm in Japan where more than 1,000 chickens have died, marking the country's first case of bird flu in three years, the Agricultural Ministry said on Sunday. The highly pathogenic H5 virus w…
      - 8 days ago, 13 Apr 14, 5:52am -
    • NASCAR owner Gene Haas granted F1 license
      DARLINGTON, S.C. (AP) — NASCAR team owner Gene Haas said Friday he has been granted a license from Formula One's governing body to start a U.S.-based entry in the series, perhaps as early as next season.
      - 9 days ago, 12 Apr 14, 12:40am -
    • Rand rally loses steam after U.S. biotech sell-off
      "The overnight near-panic selloff in biotech stocks has hit risk appetite hard and is leading to a sharply weaker rand," John Cairns, an emerging markets analyst for Rand Merchant Bank, said in a note.
      - 10 days ago, 11 Apr 14, 7:20am -
    • Biotech drops again, pulling down market
      NEW YORK (AP) — Biotech and Internet stocks tumbled again Thursday, and the broader market followed.
      - 10 days ago, 10 Apr 14, 9:44pm -
    • Stocks drop; Biotech takes another plunge
      The Nasdaq had its worst day since 2011 as investors dumped biotechnology shares and other industries that have soared over the past year. Biogen Idec, Gilead Sciences and other biotech companies plunged. ...
      - 10 days ago, 10 Apr 14, 8:16pm -
    • French plan to push copycat biotech drugs worries Big Pharma
      By Natalie Huet and Noëlle Mennella PARIS (Reuters) - France is going out on a limb with a plan to push the use of cheap copies of biotech drugs, triggering alarm among companies in Europe's second-biggest pharmaceutical market behind Germany. The g…
      - 10 days ago, 10 Apr 14, 4:45pm -
    • Japan stem cell researcher says results valid
      TOKYO (AP) — The Japanese scientist accused of falsifying data in a widely heralded stem-cell research paper said Wednesday the results are valid despite mistakes in their presentation.
      - 12 days ago, 9 Apr 14, 10:54am -
    • Japanese researcher stands by her disputed stem cell discovery
      By Elaine Lies TOKYO (Reuters) - Fighting back tears, a Japanese researcher under fire for fabricating parts of scientific papers hailed as breakthroughs in stem cell research said on Wednesday she stood by her discovery and hoped it could still help…
      - 12 days ago, 9 Apr 14, 9:19am -

    Regulatory Affairs Pharma

    • UK medtech free sale cert charges near as MHRA gets oversight
      The Department of Health in the UK is planning to transfer the oversight of the system of issuing certificates of free sale (CFS) to medical device companies to the national medicines and healthcare products regulator, the .....
      - 7 days ago, 14 Apr 14, 9:43am -
    • EU risk panel opinion out on metal-on-metal hips
      The European Commission's Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) has published its opinion on the safety of metal-on-metal hip implants1. The deadline for written comments on the.....
      - 32 days ago, 20 Mar 14, 8:47am -
    • US lawmakers introduce regenerative medicines bill
      US senators Barbara Boxer (Democrat-California) and Mark Kirk (Republican-Illinois) late last week introduced legislation aimed at establishing a national strategy to support regenerative medicine research1.
      - 34 days ago, 17 Mar 14, 6:05pm -
    • US FDA chief calls for more regulatory collaboration and capacity building 'wherever it's needed'
      Globalisation: the regulators’ response. This was the topic of this year's UK Medicines and Healthcare Products Regulatory Agency annual lecture, which was delivered by US Food and Drug Administration commissioner Margaret Hamburg.....
      - 45 days ago, 7 Mar 14, 9:20am -
    • Device registries and surveillance high on French agency agenda
      While the 2014 work program of French healthcare products regulatory body ANSM focuses overwhelmingly on pharmaceutical issues1,2, strengthening medical device surveillance for certain high-risk products is also highlighted as.....
      - 73 days ago, 7 Feb 14, 10:50am -
    • Diane returns to French market under strict conditions
      Bayer's anti-acne product Diane 35 (cyproterone/ethinylestradiol) and its generic versions are being reintroduced to the French market under strict prescribing conditions following last year's safety review by the European Medicines.....
      - 95 days ago, 16 Jan 14, 10:20am -
    • Medical head role for Christian Schneider at Danish drug licensing unit
      The Danish Health and Medicines Authority has appointed Christian Schneider medical head of the agency’s newly-created division of medicines licensing and availability1. The division was formed on 1.....
      - 17 Dec 13, 6:20pm -
    • US DEA, finally, schedules Eisai's epilepsy drug
      With the issuance of a final rule on 2 December, the US Drug Enforcement Administration placed Eisai’s epilepsy drug Fycompa (perampanel), including its salts, isomers and salts of isomers, into Schedule III of the.....
      - 9 Dec 13, 9:37am -
    • Antibiotic resistance: It's our problem to fix
      "When I'm old I don't mind if I die of pneumonia, the old man's best friend, I do mind though if I die of E. Coli [Escherichia coli], because that will be because of poor practice," the chief medical officer for England,.....
      - 6 Dec 13, 10:20am -
    • Contraceptive safety concerns to be put to bed in EU
      The risk of venous thromboembolism (VTE) does not outweigh the benefits of combined oral contraceptives in preventing unwanted pregnancies, the European Medicines Agency's Pharmaceutical Risk Assessment Committee has .....
      - 30 Oct 13, 4:47pm -

    BIO - Press

    Eye On FDA

    • Weekly Roundup – 4.18.14

      - 3 days ago, 18 Apr 14, 10:37am -
    • Release of CMS Medicare Payment Data a Sunshine Dress Rehearsal
      There were two major healthcare stories last week.  One involved the announcement that Health and Human Services Secretary Kathleen Sebelius would be leaving and the nomination by President Obama of Office of Management and Budget Director Sylvia Ma…
      - 6 days ago, 15 Apr 14, 11:25am -
    • Weekly Roundup 4.11.14

      - 9 days ago, 11 Apr 14, 5:12pm -
    • Sunset on the ROI of Social Media and Pharma Discussion
      While many pharma companies have developed a wide and deep footprint in social media, many others have not.  When exploring the issue of whether or not to involve a brand, there are several questions to consider.  Some are very important … Contin…
      - 11 days ago, 9 Apr 14, 2:48pm -
    • Weekly Roundup 4.4.14
      Dumbfounded by another week packed with business travel.  It was a week that truly involved planes, trains and automobiles.  I wish I could say that it will be a while before I am once again in an airport, but it … Continue reading →
      - 16 days ago, 4 Apr 14, 1:00pm -
    • Weekly Roundup 3.28.14
      You know I’m busy when I don’t even have time for the Weekly Roundup.  I have had a very heavy travel schedule and a workload that has been quite a heavy one.  And sadly, there is no letup in sight … Continue reading →
      - 23 days ago, 28 Mar 14, 10:49pm -
    • Weekly Roundup 3.14.14
      The nation is on the lookout for Spring.  And so am I. Despite the harsh, harsh and cold winds of this week, and the redundant snowfall last week, there nevertheless appear daffodil buds above the dirt, some quite robust in … Continue reading →
      - 37 days ago, 14 Mar 14, 12:15pm -
    • OPDP Issues Untitled Letter Involving Social Media
      Sort of. There is, of course, a difference between a regulatory action letter that is issued because of a social media use and a regulatory action letter that is issued the communication happens to involve a social media platform.  In … Continue r…
      - 40 days ago, 12 Mar 14, 11:00am -
    • Weekly Roundup 2.28.14
      Last weekend was so warm I got to take my first bike ride and went around the Mall. It was delightful with temps in the 60′s.  Early in the week, I was excited to find a blooming crocus where just … Continue reading →
      - 52 days ago, 28 Feb 14, 11:49am -
    • FDA Press Releases – What They Say
      Keeping my eye on FDA, and being most interested in communications, AND having a penchant for looking at patterns through databases, I started categorizing FDA press releases to see what they talked about and in what way.  I only started … Continu…
      - 53 days ago, 27 Feb 14, 11:40am -