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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • newBioCryst's genetic disorder drug fails study, shares slump
      (Reuters) - Drug developer BioCryst Pharmaceuticals Inc said its lead drug failed to reduce the frequency of recurrent swelling in patients with hereditary angioedema, a rare genetic condition. The company's shares slumped 41.7 percent to $3.58 in pr…
      - 7 hours ago, 8 Feb 16, 11:56am -
    • Zika found in saliva; no Carnival kissing, Brazil warns pregnant women
      By Pedro Fonseca RIO DE JANEIRO (Reuters) - Zika has been found in the saliva and urine of two patients in Brazil and while it is not known if such body fluids could transmit the virus, the discovery could make pregnant revelers wary of kissing stran…
      - 3 days ago, 5 Feb 16, 8:57pm -
    • Karolinska University to investigate stem-cell scientist
      LONDON (AP) — Sweden's Karolinska University says it is commissioning an external investigation into stem-cell scientist Paolo Macchiarini, who was cleared last year of misconduct charges related to his creation of wind pipes made from patients' st…
      - 3 days ago, 5 Feb 16, 11:55am -
    • Brazil reports Zika infection from blood transfusions
      Brazilian health officials said on Thursday they have confirmed two cases of transmission of Zika through transfusions of blood from donors who had been infected with the mosquito-borne virus that is spreading rapidly through the Americas. Marcelo Ad…
      - 4 days ago, 4 Feb 16, 9:16pm -
    • Indian company says working on two possible Zika vaccines
      By Zeba Siddiqui MUMBAI (Reuters) - Indian biotechnology company Bharat Biotech said on Wednesday it was working on two possible vaccines to fight the Zika virus, which has been linked to birth defects in thousands of babies in Brazil. No vaccine has…
      - 5 days ago, 3 Feb 16, 10:20am -
    • GSK and J&J back $1 billion biotech spin-off from Index Ventures
      Index Ventures, an early investor in technology hits like Skype and Dropbox, is spinning off its biotech portfolio into a new $1 billion (695 million pounds) business, with backing from drug giants GlaxoSmithKline and Johnson & Johnson . The new Medi…
      - 6 days ago, 2 Feb 16, 10:12am -
      Graphic explains the CRISPR-Cas9 method of gene editing; 2c x 3 inches; 96.3 mm x 76 mm;
      - 7 days ago, 1 Feb 16, 9:38pm -
    • Britain approves controversial gene-editing experiments
      LONDON (AP) — In a landmark decision that some ethicists warned is a step down the path toward "designer babies," Britain gave scientists approval Monday to conduct gene-editing experiments on human embryos.
      - 7 days ago, 1 Feb 16, 8:42pm -
    • Promise and peril: a primer on gene editing
      Britain's granting of a licence Monday for scientists to alter the genes of embryos for infertility research has thrown the controversial technique under a white-hot spotlight. Gene editing is the direct, surgical modification at the molecular level…
      - 7 days ago, 1 Feb 16, 7:30pm -
    • AP News Guide: Facts about gene editing as Britain OKs study
      WASHINGTON (AP) — Britain's decision to allow researchers to edit the genes of human embryos — not to create babies but to start unraveling the earliest stages of development — is raising new questions about the ethics of this hot new technolog…
      - 7 days ago, 1 Feb 16, 6:48pm -

    Regulatory Affairs Pharma

    BIO - Press

    Eye On FDA

    • FDA Guidance Output Plans for 2016
      While there has been focus on what FDA accomplished in 2015 – and there will continue to be some of that – it is also a great time to look ahead. What can we anticipate for 2016? This month several … Continue reading →
      - 5 days ago, 3 Feb 16, 12:36pm -
    • Weekly Roundup 1.29.16
      Well, we have gotten through the first month of the year. We had a lot of days with some pretty warm temperatures and it was evident that many of the daffodils had the idea that it might be a good … Continue reading →
      - 10 days ago, 29 Jan 16, 12:18pm -
    • FDA 2015 Report on New Drug Approvals – A Banner Year
      Greetings from the big blizzard of 2016. With life in the slow lane for a bit, it was a good time to catch up on reading. One of those was a recently issued FDA report on the novel new drugs … Continue reading →
      - 13 days ago, 26 Jan 16, 12:25pm -
    • Weekly Roundup 1.22.16
      Well, you remember last week perhaps in the Weekly Roundup when I lamented the lack of snow and commented on the fact that it can be quite enjoyable when there is a big snowfall that brings the world to a … Continue reading →
      - 17 days ago, 22 Jan 16, 12:37pm -
    • Weekly Roundup 1.15.16
      In the mid-Atlantic, it has been a winter without snow. In fact, despite a few genuinely chilly days, it has largely been balmy. I know some people don’t miss it – in fact perhaps most. But I always think there … Continue reading →
      - 24 days ago, 15 Jan 16, 12:39pm -
    • FDA Press Release 2015 – What They Said
      Last year and the year before, Eye on FDA provided an overview of press releases from the agency for the year that had just passed. The information comes from a database of press releases that I started back in 2013 … Continue reading →
      - 26 days ago, 13 Jan 16, 11:10am -
    • Weekly Roundup 1.8.16
      It is the first Weekly Roundup for 2016.  The decorations are down. The waistline is a bit increased. My resolutions seemed to be broken in record time this year. There is, of course, the back to work thing. Though much … Continue reading →
      - 31 days ago, 8 Jan 16, 2:06pm -
    • FDA Enforcement on Promotional Communications – 2015 Summary
      Happy New Year. That means that it is that time for some of those look-back postings where we look at what FDA has and has not accomplished in the course of the year we have just been through. In many … Continue reading →
      - 35 days ago, 4 Jan 16, 11:22am -
    • Weekly Roundup 12.18.15
      It is the rush. I am caught wondering how I got here.That situation that every year I say I am going to avoid, but don’t. The one where I am rushing to get everything done before the holiday that needs … Continue reading →
      - 52 days ago, 18 Dec 15, 12:47pm -
    • Weekly Roundup 12.11.15
      The trees have shrugged off the last of their leaves, allowing twinkle lights to be suspended from their branches. Stockings are hung. Trees are up. And while we may be lulled into thinking that it is going to be a … Continue reading →
      - 59 days ago, 11 Dec 15, 12:31pm -