The FDA comes up with a plan for naming biosimilars; Exelixis wins a Swiss regulatory OK for cobimetinib;

@FierceBiotech: UCSF cardiology chief builds a case for two new targets for heart drugs. FierceBiotechResearch article | Follow @FierceBiotech

@JohnCFierce: I'm happy to see $MDVN back in a late-stage development race. It's been awhile, and they're smart, aggressive players. More from FiercePharmaMarketing | Follow @JohnCFierce

> The FDA hopes that adding a simple suffix to a biosimilar name will avoid any confusion about whether the original drug or the knockoff is being prescribed. Story

> South San Francisco-based Exelixis says that Swiss officials have approved cobimetinib for advanced melanoma--a regulatory first. Release

Medical Device News

@FierceMedDev: Israeli nitric oxide drug-device player files for up to $36M Nasdaq IPO. Article | Follow @FierceMedDev

@VarunSaxena2: Providence Medical receives $12M in financing to expand sales of its spinal fusion devices. Story | Follow @VarunSaxena2

@EmilyWFierce: Recipharm strikes development deal for RedHill's bacteria-fighter candidate. FierceCRO item | Follow @EmilyWFierce

> Greatbatch grabs Lake Regional Medical for $730M to expand surgical offerings. News

> Abbott denies FT report that it's preparing $25B bid for St. Jude Medical. Article

Pharma News

@FiercePharma: Academic docs and biotechs partner with veterinarians to find cancer cures. More from FierceAnimalHealth | Follow @FiercePharma

@CarlyHFierce: Can Sprout's Addyi shrug off serious side effects? These blockbusters did. FiercePharmaMarketing article | Follow @CarlyHFierce

> Impatient Horizon accuses Depomed of stalling its shareholder meeting plans. Report

> AbbVie scores one against FTC in pay-for-delay AndroGel suit. News

> Lilly, Boehringer amp up fight against Lantus with U.K. biosim launch. Article

Vaccines News

> Pfizer's Trumenba shows 'robust' MenB protection in two PhIII trials. News

> Valneva licenses EB66 technology to develop human, veterinary vaccines. Report

> Takeda expands vaccine platform rights with Nanotherapeutics agreement. More

> FluGen reels in $12M to fund PhI of its universal flu jab. Story

> Scripps Research Institute, J&J test 'universal' flu vaccine in mice, monkeys. Article

CRO News

> WuXi inks lab testing pact with Chinese Lee's Pharm. News

> Germany lists 54 GVK suspensions as EU comes down on Indian CRO. More

> Recipharm strikes development deal for RedHill's bacteria-fighter candidate. Report

> CRO field to grow nearly 10% annually through 2019, report says. Story

> India's Accutest Research Labs expands into Latin America. Article

Pharma Manufacturing News

> Shire works deal with Sanquin so it can boost production of rare disease drug. More

> Woodcock says FDA will keep new plant quality grades a secret. Report

> Sterilization specialist on expansion streak. Item

> Sucampo gets control of Amitiza production in deal for Japanese company. Story

> Novo picks Clayton, NC, for its first U.S. API plant. Article

Pharma Asia News

> India's Gujarat state moves closer to country's first medical device testing lab. Story

> China's Shenzhen Hepalink keeps N. American deal stream rolling with Cytovance. More

> Oncology trials in China may see pilot program for 60-day IND decision. Story

> BD Life Science buys Silicon Valley-based Cellular Research, part of Decheng portfolio. Article

> Japan's PAFSC to review application from Takeda on glatiramer this week. Item

Free Webinar

From Patient Adherence to Manufacturing Ease - Why Softgels Make Sense for Rx

Join Thermo Fisher Scientific’s upcoming webinar to learn why softgels offer numerous benefits for Rx drug development, including enhanced bioavailability, patient compliance and easy scale-up. Register Today.

Suggested Articles

Polyphor is developing an inhaled version of murepavadin, which targets Pseudomonas aeruginosa infections, but is currently given intravenously.

Japanese pharma Astellas is looking to offload a series of unwanted research projects ahead of Thanksgiving; if you want one, it’s made it very easy.

A re-engineered adenovirus prolonged survival in mouse models of metastatic lung cancer and cleared tumors in about 35% of the animals.