FDA shoots down BMS' Opdivo as first-line melanoma treatment; Amgen files Humira biosim app with U.S. regulators;

@FiercePharma: Report: Sanofi cooking up $12.7B animal health spinoff. FierceAnimalHealth story | Follow @FiercePharma

@EricPFierce: ICYMI: FDA warning letter says Dr Reddy's hid existence of QC testing lab where retesting was done. Article | Follow @EricPFierce

@CarlyHFierce: ICYMI: Trump, Clinton lash out at Pfizer over Allergan deal. Article | Follow @CarlyHFierce

> Fresh off an FDA victory just days ago, Bristol-Myers Squibb's ($BMY) Opdivo hit an obstacle in melanoma; the agency denied a first-line use in that disease, saying it needs more data in patients with BRAF mutations. Report

> Amgen ($AMGN) has filed its approval application for a biosimilar copy of AbbVie's ($ABBV) best-selling Humira with U.S. regulators. Report

> Merck KGaA is reportedly weighing a sale of its allergy business. Report

> Regulators in Europe have approved Praxbind, Boehringer Ingelheim's reversal agent for its next-gen anticoagulant Pradaxa. Release

> China is zeroing in on drugs made by domestic pharma companies, threatening growth among multinationals that have benefited not only from newer products but from their own "branded generics." Report

> Spain's Almirall agreed to buy dermatology specialist Poli Group, part of its bid to move into specialty meds after selling off its respiratory drugs to AstraZeneca ($AZN) last year. Release

Medical Device News

@FierceMedDev: ICYMI: Scientists make strides with real-time estrogen sensor. Article | Follow @FierceMedDev

@VarunSaxena2: ICYMI: Entellus wins FDA clearance for its endoscope to treat blocked sinus passages. Story | Follow @VarunSaxena2

@EmilyWFierce: JAMA: Valeant's 18-fold price hikes top widespread increases in dermatology prices. FiercePharma story | Follow @EmilyWFierce

> Wright Medical slapped with $11M verdict in bellwether case over metal hip implant. More

> Novartis' Alcon recalling more intraocular lenses due to reports of postoperative inflammation. Article

Biotech News

@FierceBiotech: Star fund manager Woodford calls in ex-FBI agent to probe Northwest Bio allegations. Report | Follow @FierceBiotech

@JohnCFierce: Bristol-Myers gets elotuzumab OK for multiple myeloma -- Believe that makes 39 for the year so far. More | Follow @JohnCFierce

@DamianFierce: Actually, inversions are ... good? More from the NYT | Follow @DamianFierce

> Pfizer turns to GPCR experts at Heptares for a lineup of new drugs. Story

> Ex-Moderna chief scientist lands at PureTech to seed new biotechs. News

> Roche abandons a marquee antibiotics collaboration with Polyphor. Article

Pharma Marketing News

> What caught our readers' fancy this year? Here's your top 10 FiercePharmaMarketing capsule. Editor's corner

> Amgen slaps $178K price on rare new leukemia drug Blincyto. More

> Top cancer doc takes to social media to fight rising prices. More

> Are Glaxo's China sales reforms putting it at a commercial disadvantage? More

> Big Pharma's bad rap made late-night TV, even before the Shkreli effect. More

Animal Health News

> Scientists roll out innovative health-tracking device for guide dogs. Report

> Report: Sanofi cooking up $12.7B animal health spinoff. Story

> Merck and Zoetis line up rival vaccines to fight new strain of dog flu. More

> Nexvet focuses first investor symposium on prospects for biotech in vet medicine. Article

> Petco abandons IPO plan in favor of $4.6B buyout. Item

Biotech IT News

> U.K. commits a further $375M to 100,000 Genomes Project. News

> Pfizer-Allergan merger raises questions about future of NuMedii deal. Item

> MediSapiens applies bioinformatics to find ideal leukemia treatment regimens. Report

> With PhIII trial coming up, Infinity strikes risk-based monitoring deal with Medidata. Story

> BGI slams brakes on Revolocity rollout, lays off staff in business rethink. Article

And Finally... Sanofi Pasteur says the first doses of its new injectable polio vaccine, ShanIPV, will soon be rolling out in India, a market where oral polio vaccines are customary. Release