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Pharma/Biotech/Devices - News

    FDA - Medical Device News - News

    Yahoo! News - Biotechnolgy

    • Bluebird's gene therapy continues to show promise in early study
      (Reuters) - Biotech firm Bluebird Bio Inc said its experimental gene therapy continued to exhibit a positive effect in an ongoing early-stage study of patients with rare types of blood disorders. The product, LentiGlobin, is being tested in patients…
      - 2 days ago, 21 May 15, 4:31pm -
    • U.S. science leaders to tackle ethics of gene-editing technology
      The leading U.S. scientific organization, responding to concerns expressed by scientists and ethicists, has launched an ambitious initiative to recommend guidelines for new genetic technology that has the potential to create "designer babies." The te…
      - 5 days ago, 18 May 15, 4:51pm -
    • Gene breakthrough sparks 'home-brewed morphine' fears
      Other experts agreed, saying anyone with basic skills could use such a yeast to churn out morphine, codeine and drugs using a simple home-brew beer kit. The discovery, published in the scientific journal Nature Chemical Biology, comes on the heels of…
      - 5 days ago, 18 May 15, 4:09pm -
    • Stem cell 'Wild West' takes root amid lack of US regulation
      BEVERLY HILLS, Calif. (AP) — The liquid is dark red, a mixture of fat and blood, and Dr. Mark Berman pumps it out of the patient's backside. He treats it with a chemical, runs it through a processor — and injects it into the woman's aching knees…
      - 6 days ago, 18 May 15, 1:17pm -
    • AstraZeneca to invest $285 million in Swedish biotech drug factory
      AstraZeneca is investing $285 million to expand biotech drug manufacturing in Sweden as the company bets on the future of high-tech medicine for future growth. The new facility for biological medicines in Sodertalje will supply medicines for clinical…
      - 6 days ago, 18 May 15, 9:39am -
    • Stem cells still uncharted territory in sports
      C.J. Nitkowski had nothing to lose in spring 2011. The rotator cuff in his left shoulder that he'd relied on during his decade as a major league pitcher was in tatters. He was 38 and his fastball traveled ...
      - 6 days ago, 18 May 15, 6:48am -
    • Correction: Puma Biotechnology-Ahead of the Bell story
      In a story May 14 about Puma Biotechnology Inc.'s cancer drug neratinib, The Associated Press erroneously reported the design of the study. Patients had been given the breast cancer drug Herceptin in the ...
      - 8 days ago, 15 May 15, 5:50pm -
    • Stem cell manufacturer breaks ground in northern Vermont
      Construction has begun on a $100 million stem cell research and manufacturing facility. The AnC Bio Vermont groundbreaking took place Thursday at the former Bogner plant in Newport, near the Canadian border. ...
      - 8 days ago, 15 May 15, 4:48pm -
    • Puma Biotechnology plunges on breast cancer drug data
      Shares of Puma Biotechnology Inc. plummeted Thursday on disappointing results from a study of the company's breast cancer drug. The study involved treatment through the use of Puma's neratinib in combination ...
      - 9 days ago, 14 May 15, 7:12pm -
    • Avalanche Biotech reports 1Q loss
      On a per-share basis, the Menlo Park, California-based company said it had a loss of 38 cents. The results topped Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment ...
      - 11 days ago, 13 May 15, 11:10am -

    Regulatory Affairs Pharma

    BIO - Press

    Eye On FDA

    • Weekly Roundup 5.15.15
      Today is one of those days where if you took the date and read it backwards – 5.15.15, it would still be the same date and it has pretty much been that way all week. 5.14.15, 5.13.15 and so on. … Continue reading →
      - 6 days ago, 17 May 15, 3:38pm -
    • The Guidance that Dare Not Speak Its Name
      In December 2014, Commissioner Hamburg announced a proposed change in the FDA’s long-standing policy regarding blood donations from gay men – See “FDA Commissioner Margaret A. Hamburg’s statement on FDA’s Blood Donor Deferral Policy for Men…
      - 10 days ago, 13 May 15, 4:36pm -
    • Weekly Roundup 5.8.15
      It is one of my three favorite times of year – the days are so much longer – the evenings cool and pleasant for sleeping near open windows – the mornings crisp and the afternoons languidly warm. Flowers abound. There … Continue reading →
      - 16 days ago, 8 May 15, 2:28pm -
    • Weekly Roundup 5.1.15
      Happy May Day! As much of the world celebrates the worker, here we toil to bring you this week’s latest. We are well into the second quarter of the year – hard to believe – and are having those kinds … Continue reading →
      - 22 days ago, 1 May 15, 2:54pm -
    • FDA Press Releases – 1st Quarter 2015
      Last year I began a new database that tracks the press releases of FDA as a way to see what news the agency is talking about and provided a year end look at 2014. Looking back at the quantity and … Continue reading →
      - 25 days ago, 29 Apr 15, 10:22am -
    • Weekly Roundup 4.24.15
      It is that time of year when the temperatures can range by 30 degrees from morning until afternoon. The pollen counts are high and already sudden storms appear on the horizon to dump a lot of rain and then move … Continue reading →
      - 29 days ago, 24 Apr 15, 6:59pm -
    • The Regulation of Search
      Where are we when it comes to the regulation of search and digital media by FDA? After issuing some guidance documents, we know a little more about FDA’s approach to digital and social media, but there are still many outstanding … Continue readin…
      - 32 days ago, 22 Apr 15, 2:17pm -
    • 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 →
      - 36 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…
      - 38 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…
      - 50 days ago, 3 Apr 15, 5:34pm -