Posts Tagged ‘medical devices’


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  • FDA Has (Some) Social Media Advice For Pharma

    Tuesday, January 10th, 2012 at 05:30 | Comments Off

    The pharma industry has been waiting for guidance from the FDA on what is — and is not — permitted in terms of marketing online and via social media. (For example — who’s responsible for consumer Tweets about a drug?)

    Hearings on the topic were held in November 2009 but so far there hasn’t been much information on how companies can adhere to rules about things such as balancing information on risks and benefits when using social media.

    Then, late last month, ..read more

  • A.M. Vitals: How Men and Women Sleep Differently

    Tuesday, August 23rd, 2011 at 22:26 | Comments Off

    Men and Women, Sleeping: Men and women sleep differently, with women experiencing deeper sleep, waking up fewer times during the night, and tolerating a lack of shut-eye better than men — even as men report greater overall satisfaction with their sleeping patterns, the WSJ reports. Research into gender and sleep differences may help explain the generally better health status of women compared to men, the paper says.

    Hip Problems: Complaints about metal-on-metal hip implants have risen by more ..read more

  • For Kids Needing a Heart Transplant, a Pump to Help Them Get There

    Wednesday, August 3rd, 2011 at 06:13 | Comments Off

    A heart pump for kids awaiting a transplant appears headed for approval at the FDA, as the WSJ reports. It would help fill a void for lot of children hit by diseases usually associated with adults: the lack of kid-friendly devices to help in their care.

    The Berlin Heart can help keep kids’ hearts beating for several months if necessary until a donor organ can be found, much longer than a last-ditch heart-lung machine called ECMO that doctors sometimes use ..read more

  • Boston Scientific’s Elliott Spooks Investors With Retirement

    Wednesday, May 11th, 2011 at 05:57 | Comments Off

    Less than two years ago, in a move analysts called “surprising” and “abrupt,” Boston Scientific said Ray Elliott would take over as CEO.

    Today Elliott again surprised investors — by announcing his plans to retire at the end of the year. Boston Scientific shares fell on the news, and were down more than 9% to $6.99 in late trading.

    As the WSJ reports, hopes for the company’s turnaround — and improved earnings — were largely lodged with Elliott. (He was seen as ..read more

  • Digesting Synthes May Not Be Easy for Johnson & Johnson

    Thursday, April 28th, 2011 at 01:28 | Comments Off

    Johnson & Johnson, which has grown into a health-care powerhouse by acquiring small firms, is no stranger to making deals. But it’s never done anything as big as the one announced today, for device-maker Synthes. That could make digesting the new business thorny, even for a company as adept as J&J.

    The $21.3 billion takeover of the surgical-device maker will be J&J’s biggest, eclipsing its $16.6 billion purchase of Pfizer’s consumer business in 2006.

    J&J  likes to allow its acquisitions to operate ..read more

  • J&J Stays Mum on Synthes Talks

    Wednesday, April 20th, 2011 at 02:15 | Comments Off

    Medical-technology company Synthes has confirmed it’s in talks with Johnson & Johnson about being taken over by the U.S.-based health-care behemoth. (Sources tell the WSJ the deal could be worth at about $20 billion.)

    But J&J had little to say on the topic today. There was nothing about those discussions in its first-quarter earnings results (which, by the way, exceeded analysts’ expectations and in doing so helped lead the market higher this morning.)

    On a conference call with analysts, J&J wouldn’t comment ..read more

  • A.M. Vitals: Synthes Purchase Would Boost J&J’s Device Business

    Monday, April 18th, 2011 at 22:48 | Comments Off

    Deal Talk: Johnson & Johnson is conducting due diligence of Synthes as the companies discuss a deal that could be worth $20 billion and would give a needed boost to J&J’s orthopedic device business, the WSJ reports. Synthes — which makes plates and screws used in surgery to repair broken bones — has confirmed that it’s in talks with J&J, while J&J tells the paper it doesn’t comment on speculation.

    Sex Commentary Scandal: The president-elect of the American ..read more

  • A.M. Vitals: Pfizer and Novartis Drugs Get FDA Panel Recommendation

    Wednesday, April 13th, 2011 at 22:25 | Comments Off

    FDA Panel Votes: Kidney-cancer drugs made by Pfizer and Novartis have received a thumbs-up from an FDA advisory panel, bolstering their chances of gaining approval to also treat rare advanced pancreatic neuroendocrine tumors, the WSJ reports. The panel voted 10-0 on the question of whether the benefits of Novartis’s Afinitor outweighed the risks, and voted 8-2 on a similar question about using Pfizer’s Sutent for tumors that cannot be removed surgically. We have to say it: the ..read more

  • J&J Recall Watch: 360,000 surgical wound drainers

    Friday, March 25th, 2011 at 04:13 | Comments Off

    Johnson & Johnson announced another recall today, this time pulling about 360,000 products sold in the U.S. for use draining surgical wounds, Dow Jones Newswires reports.

    J&J’s Ethicon unit, which makes the Blake Silicone Drains, J-VAC reservoirs and other withdrawn products, says it hasn’t received any reports of side effects. The company said it decided to recall the devices after customers complained the sterile packaging could be compromised.

    The company blamed the problem on an unidentified contract manufacturer. Here’s the company’s letter ..read more

  • A.M. Vitals: J&J-FDA Tussle Highlights Medical Device Approval Debate

    Saturday, February 19th, 2011 at 00:44 | Comments Off

    Also: a quick guide to states’ planned Medicaid cuts; asking for clarification on health-care overhaul ruling; how to talk about cancer.

    Go here to read the rest:  A.M. Vitals: J&J-FDA Tussle Highlights Medical Device Approval Debate