The FDA's device arm is hoping to secure an additional $500 million in user fees over 5 years via the reauthorization of the fourth Medical Device User Fee Act. The agency proposed adding 20 employees to establish a quality management team, about 50 to review regulatory submissions and 15 to evaluate postmarket data. But first it needs to get the backing of industry, which will foot the bill for the increased efforts via additional user fees. More
@FierceMedDev: ICYMI: Boston upstart raises $46M, makes acquisition for translational imaging in biopharma R&D. Article | Follow @FierceMedDev
@EmilyWFierce: FDA is asking for more tests to evaluate the risk of Bayer's birth control implant Essure. More from Reuters | Follow @EmilyWFierce
> 23andMe Chief Scientific Officer Richard Scheller said the company's "spit kits" will soon be available at Walgreens ($WBA). The company later walked back the statement, saying there is nothing imminent to announce, but he may have nevertheless revealed some of the company's longer-term plans. More
> New FDA Commissioner Dr. Robert Califf said pushing for integration of Unique Device Identifiers into electronic health records and Medicare bills is one of his priorities. The stance that could put him into conflict with Medicare provider CMS, which has said it doesn't believe the effort justifies the costs. More
Biotech News
@FierceBiotech: Top asthma drug at Roche posts 1 win, 1 flop in identical PhIIIs. Report | Follow @FierceBiotech
@JohnCFierce: In a setback, AstraZeneca's immunotherapy tremelimumab flunks mesothelioma test. Story | Follow @JohnCFierce
@DamianFierce: my only Oscar opinions: World of Tomorrow and Anomalisa got robbed. | Follow @DamianFierce
> Sanofi scouts for rare disease buyouts as Shire bears down on the field. Story
> Boehringer and AbbVie are reportedly weighing a multibillion-dollar cancer alliance. More
> 'Brexit' risks serious side effects for U.K. life sciences. Article
> With ataluren under a cloud, PTC plunges (again) after a market setback in Germany. Report
Pharma News
@FiercePharma: Hoping Vivus and Orexigen can finally kick-start their obesity meds? Don't count on it, analyst says. More from FiercePharmaMarketing | Follow @FiercePharma
@EricPFierce: ICYMI from FiercePharmaManufacturing: Novartis finds buyer for antibiotic intermediates plant in Frankfurt-Höchst that was set to close. Article | Follow @EricPFierce
@CarlyHFierce: Pearson sweeps back into Valeant with a slate of fix-it promises. Report | Follow @CarlyHFierce
> Bristol-Myers leads immuno-oncology race but Merck, AstraZeneca and Roche still have contenders. More
> GlaxoSmithKline scouts for candidates to replace CEO Andrew Witty. Article
Pharma Marketing News
> Jardiance, Belsomra and Entyvio brand managers share DTC honors with oldsters like Viagra. More
> Flu vaccine brands struggle for recognition even when in fab fighting form. Report
> Takeda aims to unlock $2B in Entyvio sales with multipronged DTC push. Story
> Hoping Vivus and Orexigen can finally kick-start their obesity meds? Don't count on it, analyst says. Article
> Pearson returns to Valeant with promise to boost payer, government relations. Item
Animal Health News
> Animal Health acquisition pushes Patterson's Q3 earnings past estimates. News
> Animal health boosts Bayer's sales growth but 2016 forecast disappoints. Item
> Zoetis wins approval for monthly flea-fighting pill, setting up three-way rivalry. Report
> Oasmia repositions chemo drug for dogs in bid to grab larger market. Story
> High-flying Parnell dips as 2015 revenue and 2016 guidance miss estimates. Article
Biotech IT News
> NIH calls on EHR developers to facilitate Obama's PMI through the use of open APIs. More
> FDA challenges industry to improve reproducibility and accuracy of informatics pipelines. Story
> NY Genome Center enlists IBM to create Watson-enabled cancer research platform. Report
> HHS taps Medidata for data to inform research into drug development costs. Item
> Illumina calls in the lawyers to curb the rise of Oxford Nanopore. Article