Medtech News

Senator Kirsten Gillibrand Addresses Future Plans for Upstate New York During Visit to Welch Allyn

Wed, 15 Feb 2012 00:00:00 GMT

SKANEATELES, N.Y.—FEBRUARY 15, 2012—Senator Kirsten Gillibrand addressed the members of MedTech and many others who were in attendance for her visit last Friday to Welch Allyn’s medical manufacturing facility in the Finger Lakes.

The senator spoke about Upstate New York and her plans for reviving the manufacturing industry in the region. MedTech members voiced concerns about the instability of tax credits for research and development, shortage of angel...

Medical Innovation: How the U.S. Can Retain Its Lead

Tue, 14 Feb 2012 00:00:00 GMT

Medical Innovation: How the U.S. Can Retain Its Lead

The FDA should approve drugs based on safety and leave efficacy testing for post-market studies.

By ANDREW VON ESCHENBACH

We stand on the cusp of a revolution in health care. Advances in molecular medicine will allow us to develop powerful new treatments that can cure or even prevent diseases like Alzheimer's and cancer. Tomorrow's high-tech cures can...

Bristol-Myers Squibb Completes Acquisition of Inhibitex, Inc.

Mon, 13 Feb 2012 00:00:00 GMT

NEW YORK--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) announced today the successful completion of the tender offer by Bristol-Myers Squibb Company (“Bristol-Myers”) for all of the outstanding shares of common stock of Inhibitex, Inc. (NASDAQ: INHX) (“Inhibitex) at a purchase price of $26.00 per share. As of the expiration of the offer, 77,532,611 shares of common stock of Inhibitex were validly tendered and not withdrawn in the tender offer. As of the...

FDA's new budget heavily reliant on user fees

Mon, 13 Feb 2012 00:00:00 GMT

The Food and Drug Administration requested a $4.5 billion budget in the Obama administration's $3.8 trillion 2013 federal budget proposal, released Monday, more than 40 percent of which will come from industry user fees.

Dotmed News

U.S. FDA sets draft rules for biotech drug copies

Thu, 09 Feb 2012 00:00:00 GMT

* Proposed rules set abbreviated approval pathway

* Requirement for clinical trials on case-by-case basis

* FDA would weigh product complexity, formulation, stability

The U.S. Food and Drug Administration's long-awaited guidelines for the sale of lower-cost versions of biotechnology drugs leave open the possibility that some products might not need to be tested in humans.

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Chemists Harvest Light to Create 'Green' Tool for Pharmaceuticals

Thu, 09 Feb 2012 00:00:00 GMT

A team of University of Arkansas researchers, including an Honors College undergraduate student, has created a new, "green" method for developing medicines. The researchers used energy from an ordinary 13-watt compact fluorescent light bulb to create an organic molecule that may be useful in the treatment of Alzheimer's and other brain diseases.

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Unemployment picture brightens for US, but not for pharmas

Thu, 09 Feb 2012 00:00:00 GMT

Federal Reserve Chair Ben Bernanke isn't savoring the drop in the US unemployment rate to 8.3%, the lowest in three years, and the pharmaceutical industry can definitely relate.

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Greatbatch unit to work with California firm

Thu, 09 Feb 2012 00:00:00 GMT

An arm of Greatbatch Inc. has signed a sales distribution agreement with a medical instruments manufacturer in California.

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DNA Sequencing Helps Identify Cancer Cells for Immune System Attack

Wed, 08 Feb 2012 00:00:00 GMT

DNA sequences from tumor cells can be used to direct the immune system to attack cancer, according to scientists at Washington University School of Medicine in St. Louis.

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Sanofi and Bristol-Myers Squibb Collect Damages in Plavix Patent Litigation with Apotex

Wed, 08 Feb 2012 00:00:00 GMT

PARIS & NEW YORK--(BUSINESS WIRE)--Sanofi (EURONEXT: SAN and NYSE: SNY) and Bristol-Myers Squibb Company (NYSE: BMY) announced today that Apotex has made payment in the amount of $442,209,362 to Sanofi and Bristol-Myers Squibb to satisfy the damages ruling of the Plavix® (clopidogrel bisulfate) patent infringement case against Apotex. This payment, which follows the decision of the U.S. Court of Appeals for the Federal Circuit in October 2011 upholding the payment of damages to...

Delays in MDUFA Agreement Threaten Omnibus User Fee Bill

Wed, 08 Feb 2012 00:00:00 GMT

Rather than breaking device user fees out of an omnibus bill, House Energy & Commerce Health Subcommittee Chair Joe Pitts (R-Pa.) reportedly has threatened to freeze device fees at current levels for five years if the FDA and industry can't speed up an agreement on Medical Device User Fee Act (MDUFA) reauthorization. Pitts used a Feb. 1 hearing on the Prescription Drug User Fee Act (PDUFA) to express disappointment in the slow pace of FDA-industry negotiations on device user...

StartFast Accelerator needs your referrals!

Tue, 07 Feb 2012 00:00:00 GMT

UVC is very excited at the opportunity to launch the StartFast Venture Accelerator in Syracuse, NY. Modeled on the highly successful Techstars programs, StartFast is a private capital backed effort to bring the best software/internet/ mobile startups, as well as world class mentors and investors to Upstate NY each summer. The program is now accepting applications via its website ( http://startfast.net ).

We believe the best way to find strong startups is if our...

WHITE: FDA’s assault on mobile technologies

Tue, 07 Feb 2012 00:00:00 GMT

New regulations could be death blow to smartphone medical apps.

Mobile technology has the potential to improve all aspects of our lives, and in many cases, it is already doing so. From getting step-by-step directions when we're lost to playing video games when we're bored, there are apps for every facet of life - including your health care.

The Washington Times

GAO Finds Lack of Price Transparency May Drive Up Medical Device Costs

Mon, 06 Feb 2012 00:00:00 GMT

Washington, DC (February 6, 2012) – The Healthcare Supply Chain Association (HSCA) applauded the U.S. Government Accountability Office for its new report, Lack of Price Transparency May Hamper Hospitals’ Ability to Be Prudent Purchasers of Implantable Medical Devices, which found that pricing secrecy in the medical device marketplace may drive up healthcare costs for hospitals and Medicare. The GAO examined pricing information for expensive implantable medical devices (IMD)...

FDA pushes worldwide, uniform device code

Mon, 06 Feb 2012 00:00:00 GMT

Millions of Americans are walking around with artificial joints, pacemakers, stents and other implants. But federal regulators know more about where a pallet of dog food went than a batch of hip replacements.

Politico