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Pharma/Biotech/Devices

Pharmainfo.net - News

    FDA - Medical Device News

    FierceBiotech.com - News

    • newAbbVie's $55B deal for Shire is officially dead. Now what?
      Shire and AbbVie have formally called it quits on a planned $55 billion merger, leaving each company to get by on the merits of its own pipeline and talk up the benefits of life without the other.
      - 39 mins ago, 21 Oct 14, 12:52pm -
    • newDespite a mid-stage miss, Cytokinetics is taking its ALS drug toward Phase III
      Earlier this year, Cytokinetics tanked as its lead prospect, a treatment for amyotrophic lateral sclerosis (ALS), missed its primary endpoint and a slew of secondary goals in a mid-stage trial. But the drug did come through on one measure of lung fun…
      - 18 hours ago, 20 Oct 14, 7:59pm -
    • newNovartis clears an FDA hurdle with its pioneering psoriasis treatment
      A panel of FDA advisers voted unanimously in favor of approving Novartis' new anti-inflammatory treatment, an expected positive outcome for the company as it races to be first in line among what promises to be a crowded field.
      - 19 hours ago, 20 Oct 14, 6:47pm -
    • newLeft at the altar by AbbVie, Shire has cash, options and an M&A pedigree
      While its merger with AbbVie is looking dead, Shire is likely in line for a $1.6 billion breakup fee, cash that could fund a major M&A push. And with renowned dealmakers in its executive ranks, Shire may not be lonely for long.
      - 22 hours ago, 20 Oct 14, 3:11pm -
    • newTesoRx licenses oral low-T drug to Aspen amid FDA crackdown
      While the testosterone therapy field is under fire from government regulators, Menlo Park, CA-based TesoRx is licensing its oral-testosterone replacement therapy to a subsidiary of South African generics maker Aspen Pharmacare.
      - 23 hours ago, 20 Oct 14, 2:46pm -
    • newCubist CEO Bonney hands over reins as new buyout rumors circulate
      After 11 years at the helm of Cubist Pharmaceuticals, CEO Michael Bonney is stepping down and handing the reins to COO and President Robert Perez.
      - 24 hours ago, 20 Oct 14, 1:58pm -
    • Celgene's $2.6B deal for Crohn's drug pays off with promising PhII
      Celgene bet big on the little-known Irish biotech Nogra Pharma when it partnered on a mid-stage drug for Crohn's disease. And today Celgene spelled out the reasons why it gambled $710 million upfront on a Phase II drug, highlighting data that support…
      - 1 day ago, 20 Oct 14, 1:14pm -
    • Top 10 Phase III disasters of 2014
      Welcome to the hall of shame, where blockbuster drug projections go to die. This list includes some drugs that clearly should never have wound up in Phase III to begin with, a few that were steered back to the clinic in a doomed attempt to mine somet…
      - 1 day ago, 20 Oct 14, 12:15pm -
    • PureTech reels in $55M to fund new biotech bets
      Biotech startup machine PureTech has raised a $55 million round to fund the next stage of its evolution, recruiting some big thinkers to help it advance its stable of ventures and develop new technologies.
      - 1 day ago, 20 Oct 14, 12:02pm -
    • Genentech pays $150M upfront to partner on NewLink's immuno-oncology drug
      Biotech powerhouse Genentech is going all in with Ames, IA-based NewLink Genetics, partnering on an early-stage cancer program which has been billed as an important example of a new class of checkpoint inhibitor. And Genentech says that it plans to b…
      - 1 day ago, 20 Oct 14, 11:43am -

    Yahoo! News - Biotechnolgy

    • Embryonic stem cells clear key hurdle in eye trial
      Paris (AFP) - Embryonic stem cells transplanted into 18 patients with deteriorating eyesight restored some vision in more than half the volunteers, the longest study into the fledgling technology reported Tuesday.
      - 7 days ago, 14 Oct 14, 11:55pm -
    • Stem cells from human embryos prove safe, improve vision -study
      By Sharon Begley NEW YORK (Reuters) - The longest-running trial of stem cells derived from a human embryo found that the cells caused patients none of the problems scientists feared, such as forming tumors, and reversed partial blindness in about hal…
      - 7 days ago, 14 Oct 14, 11:04pm -
    • Medical, biotech stocks jump after U.S. nurse contracts Ebola
      By Yasmeen Abutaleb NEW YORK (Reuters) - Shares of little-known medical equipment and biotech companies jumped on Wall Street on Monday, after news that a nurse had become the first person to contract the deadly Ebola virus in the United States. Airl…
      - 8 days ago, 13 Oct 14, 10:52pm -
    • Love of coffee at least partly genetic: study
      By Kathryn Doyle NEW YORK (Reuters Health) - Need that cup of joe to get going in the morning? Or avoid it because java tends to make you strung out? Either way, the reasons may be written in your genes. A new analysis of tens of thousands of human g…
      - 11 days ago, 10 Oct 14, 3:12pm -
    • Stada secures third license for copycat biotech drug: CEO
      By Frank Siebelt and Ludwig Burger BAD VILBEL Germany (Reuters) - Germany's Stada plans to bring a copy of Eli Lilly's Forteo osteoporosis treatment to market, its chief executive said, as the generic drugmaker moves further into the sale of cheaper…
      - 11 days ago, 10 Oct 14, 12:24pm -
    • Highways fragment Southern California mountain lion gene pool
      By Steve Gorman LOS ANGELES (Reuters) - Mountain lions in Southern California are under growing pressure from a shrinking gene pool, fragmented by highways and urban sprawl that has left the cats' territories increasingly isolated from each other, a…
      - 13 days ago, 8 Oct 14, 11:00pm -
    • New gene therapy treatment showing promise against 'bubble boy' disease
      By Gene Emery NEW YORK (Reuters Health) - More than a decade ago, doctors showed dramatic progress in helping infants born with a severe deficiency in their immune systems, a condition known as "bubble boy" disease. But when one quarter of treated ch…
      - 13 days ago, 8 Oct 14, 9:08pm -
    • Hyperion, Clal Biotech resolve dispute over diabetes drug
      JERUSALEM (Reuters) - Hyperion Therapeutics and Clal Biotechnology Industries said they agreed to resolve their dispute after Hyperion halted development of a diabetes drug it bought from Clal due to manipulation of trial data. Hyperion had bought Is…
      - 14 days ago, 7 Oct 14, 12:25pm -
    • Britain leads Europe in biotech fundraising
      LONDON (Reuters) - Britain is the top European nation for biotechnology capital raised in the first half of 2014, a vindication of the government's strategy to encourage the life sciences through incentives including tax breaks. The country raised a…
      - 14 days ago, 7 Oct 14, 10:39am -
    • BrainStorm gets FDA fast-track status for ALS stem cell therapy
      TEL AVIV (Reuters) - Israel's BrainStorm Cell Therapeutics said the U.S. Food and Drug Administration has designated its adult stem cell treatment as a "fast-track" product for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm's treatm…
      - 14 days ago, 7 Oct 14, 8:26am -

    Regulatory Affairs Pharma

    BIO - Press

    Eye On FDA

    • Weekly Roundup – 10.17.14
      Missed last week and sorry about that and this week’s roundup is a day late.  It has been a busy Fall and even yesterday was a travel day.  I can barely keep up with how quickly the year is passing. … Continue reading →
      - 3 days ago, 18 Oct 14, 3:26pm -
    • AdComms for Last Quarter of 2014
      It is hard to believe it, but we have entered the final quarter of 2014.  I thought it a good time to revisit the upcoming AdComm schedule for those AdComm meetings that affect drugs or devices. Prior postings that provided … Continue reading →
      - 6 days ago, 15 Oct 14, 9:56am -
    • Weekly Roundup 10.3.14
      Back from a brief vacay to discover that leaves are littering the yard and porch as if it were autumn and then realizing that it is, in fact, autumn.  The year is going by so quickly and there is so … Continue reading →
      - 18 days ago, 3 Oct 14, 2:50pm -
    • Less Characters, More Tweets – A Few Tweeting Tips
      It is hard to believe that a service that limits your speech to 140 characters would emerge as an important media platform, but it has.  News travels more quickly, is more granular in nature, can very specific to highly targeted … Continue reading…
      - 19 days ago, 2 Oct 14, 1:49pm -
    • Weekly Roundup 9.26.14
      I bring you the Weekly Roundup today from Cape Cod where there is a lovely sense of autumn in the air, but blue skies and lovely shoreline allowing us to still remember the summer’s most pleasant days. And here is … Continue reading →
      - 25 days ago, 26 Sep 14, 3:13pm -
    • Here Comes the Sun – Communications Tips on The Sunshine Data Publication
      The Sunshine Act will peek out from behind some, but not all, of the clouds on the horizon soon, leading to a new day in transparency on payments between the medical products industry and those who provide care.  Data will … Continue reading →
      - 29 days ago, 22 Sep 14, 1:22pm -
    • Weekly Roundup 9.19.14
      Argh!  It is International Talk Like a Pirate Day! Fear not Matey!  I’m not gonna write my whole posting in pirate-speak, though it be a tempting morsel to ponder. There were lots of approvals this week and finally a wee … Continue reading →
      - 32 days ago, 19 Sep 14, 2:32pm -
    • Talking Points for When People Who Don’t Get Social Media as a News Platform
      Someone asked me the other day something to the effect of this – what is the point of social media when it comes to news – isn’t CNN just as fast? It occurred to me that many of us in … Continue reading →
      - 34 days ago, 17 Sep 14, 3:03pm -
    • Weekly Roundup 9.5.14
      After a surprisingly mild August, September begins with summer in full force – heat, humidity and a mosquito rally that is immensely annoying.  Forecasts however predict that we only have one more day of this and then a break to … Continue readi…
      - 46 days ago, 5 Sep 14, 3:42pm -
    • Tracking 10 Healthcare Beat Reporters on Twitter
      It is not news that social media has fundamentally changed the way we communicate. Today, we share news, we don’t just read it.  A news cycle is every moment of every day. We rely on people to pitch news to … Continue reading →
      - 48 days ago, 3 Sep 14, 12:10pm -