Biosim group decries CMS proposal on billing; Merck's Keytruda nabs another 'breakthrough' tag;

@FiercePharma: Novartis sees doc-education push, DTC as crucial to amping up Entresto launch. FiercePharmaMarketing story | Follow @FiercePharma

@EricPFierce: ICYMI: Pfizer and GlaxoSmithKline are collaborating on continuous manufacturing. FiercePharmaManufacturing item | Follow @EricPFierce

@CarlyHFierce: Shire locks down rivals to its rare-disease franchise with $5.9B Dyax buy. News | Follow @CarlyHFierce

> The Centers for Medicare and Medicaid Services' proposal to lump all biosimilars together under one payment code saw some pushback from industry groups, which want independent billing codes and payment calculations. Release

> Merck & Co. ($MRK) won the FDA's breakthrough designation for its immuno-oncology therapy Keytruda in colorectal cancer; the drug is already approved to treat melanoma and lung cancer. Release

> GlaxoSmithKline ($GSK), Roche ($RHHBY) and Sanofi ($SNY) all have major investor presentations this week, highlighting their R&D pipelines, and, in Sanofi's case, a new strategy from its new CEO, Olivier Brandicourt. Report

> The Jordanian drugmaker Hikma once again cut its generics sales forecast on slower-than-expected performance by a new gout drug. Report

Medical Device News

@FierceMedDev: 450+ hospitals pay DOJ $250M for overuse of ICDs at the expense of Medicare. Report | Follow @FierceMedDev

@VarunSaxena2: ICYMI: Flowonix to develop drug delivery implant for Cerebral's neurological candidates. Story | Follow @VarunSaxena2

@EmilyWFierce: ICYMI Friday: Quest Medical launches recall for open heart surgery drug delivery devices. Article | Follow @EmilyWFierce

> Conventus bags $21M in equity to commercialize minimally invasive implants to treat fractures. More

> Researchers develop topical device that measures skin health, blood flow. Story

Biotech News

@FierceBiotech: The top 10 biopharma pipeline disasters of 2015. Feature | Follow @FierceBiotech

@JohnCFierce: ICYMI: AstraZeneca's olaparib looks promising for a targeted set of prostate cancer patients. Story | Follow @JohnCFierce

@DamianFierce: Solid use of the double question mark in the otherwise disappointing Citron $VRX screed. More | Follow @DamianFierce

> Bristol-Myers bets $2B on Cardioxyl's heart failure therapy. Report

> Boehringer expands its crowdsourced research to include psychiatric R&D. Item

> Merck KGaA inks cancer metabolism drug discovery alliance with Selvita. Article

Animal Health News

> Investors cheer Abaxis but trounce IDEXX on quarterly diagnostics performance. More

> NexGard demand drives strong Q3 growth for Sanofi's Merial. Item

> Tufts vet borrows techniques from human medicine to repair facial fractures in dogs. Story

> Colorado State University scientists use fertility know-how to revive Yellowstone bison. Report

> VCA beats on earnings but misses the mark on revenue in Q3. Article

Biotech IT News

> Ex-BGI CEO sets up AI-enabled health data mining operation. Report

> Genomics boom puts strain on data storage, electricity grid. Story

> Alibaba, BGI and Intel team up for precision medicine project. Article

> Chinese sequencing sector heats up as BGI, Direct Genomics prepare products. Item

> FDA seeks industry feedback on virtual and BYOD clinical trials. More

Pharma Marketing News

> Shire dodges HAE competition with $5.9B Dyax buyout. Item

> Sanofi's Auvi-Q recall puts Mylan's rival EpiPen in full control of blockbuster market. Report

> Novartis sees doc-education push, DTC as crucial to amping up Entresto launch. Story

> Feds arrest, charge ex-Warner Chilcott sales execs in kickbacks case. More

> GSK readies respiratory sales force to challenge Xolair in severe asthma. Article

And Finally... An Oregon teenager was found to have bubonic plague amid an increase in such cases that have scientists wondering why. Report