/Device user fee renewal bill passes crucial subcommittee; Covidien launches new hypertension treatment;
NEWS

Device user fee renewal bill passes crucial subcommittee; Covidien launches new hypertension treatment;

FierceBiotech
2012/05/08

@FierceMedDev: Baxter is facing an SEC subpoena for records of its 2010 pump recall. More | Follow @FierceMedDev

A health subcommittee of the U.S. House of Representatives has signed off on a bill that would renew the FDA's user fee program for medical device and drug companies. Story

The FDA has approved St. Jude's ($STJ) Assura line of implantable defibrillators, which are designed to reduce the amount of inappropriate shocks. More

Covidien ($COV) is set to unveil OneShot, its new treatment for drug-resistant hypertension, at the EuroPCR conference in Paris on May 16. Story

Devicemaker Aethelon Medical is touting positive results from a 90-day test of its hepatitis C-treating Hemopurifier, as all patients treated with the device were left with no detectable traces of the virus. Release

Guided Therapeutics thinks its LuViva cervical scanner can be combined with HPV testing to optimize early detection of cervical cancer, and a new study estimates that the device could help reduce overtreatment of false positives by 33%. News

The Corporate Whistle Blower Center is launching an initiative to investigate the U.S. Medical Device industry for alleged corruption regarding the sale of defective surgical implants. Release

Pharma News

@FiercePharma: Response to Cipla's cancer-drug price cuts in India has execs mulling more—Reuters | Follow @FiercePharma

Novartis may weigh Lucentis price cut in U.K. News

Abbott to pay $1.6B to wrap up Depakote marketing probe. More

Docs riled by FDA's proposal to open up drug access. Article

Sanofi plant starts shutdown with 112 layoffs. Spotlight

Biotech News

@FierceBiotech: Honeybee substance freezes prostate cancer growth (Hint: it's not honey) More | Follow @FierceBiotech

@RyanMFierce: Talon takes it in the teeth, back to penny stock, after FDA says more time needed 2 review lead cancer drug. Bloomberg | Follow @RyanMFierce

Talon sinks after FDA prolongs cancer drug review. Article

Amgen, VC groups pump $16.5M into Sutro Biopharma. News

Eleven adds $20M in venture cash as it preps for the clinic. More

Arena shares up after FDA briefing on lorcaserin. Story

Medical Devices News

@FierceMedDev: Baxter is facing an SEC subpoena for records of its 2010 pump recall. More | Follow @FierceMedDev

Boston Scientific's CEO: CRM business in active rebuilding mode. Article

Canada's Monteris snags $9M in investments for NeuroBlate. News

Dutch test boosts prospects for photoacoustic breast imaging device. Story

Allergan subpoenaed over Lap-Band obesity device. More

Pharma Manufacturing News

Baxter bitten again by problems with Colleague infusion pumps. News

Pfizer to grow manufacturing capacity in Indonesia. Article

Sanofi closing plant in Missouri, 4 years later than expected. More

BASF erecting 50,000-ton-plus formic acid plant in Louisiana. Story

Biotech Research News

Researchers find key to premature aging syndrome. Spotlight

Controversial bird flu study details revealed. Article

Stem cells grown from skin treat muscular dystrophy in mice. News

Stem cell/gene therapy holds HIV at bay in mouse trials. More

And Finally ... The law firm Bernstein Liebhard LLP wants to know whether corporate pressure cited by a survey of FDA workers had any impact on the approval process for vaginal surgical mesh and metal hip implants. The 2011 survey by the Union of Concerned Scientists, released earlier this year, revealed some regulators expressed concern about "the influence of special interests on device approval decisions." Release

Summary

@FierceMedDev: Baxter is facing an SEC subpoena for records of its 2010 pump recall. More | Follow @FierceMedDev > A health subcommittee of the U.S. House of Representatives has signed off on a...