FDA hands Clovis a delay on rociletinib app; Alkermes highlights pipeline advances;

@FierceBiotech: Array's melanoma drug clears Phase III with an FDA filing in sight. More | Follow @FierceBiotech

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> Clovis Oncology ($CLVS) is facing a three-month delay at the FDA with its application for rociletinib. The biotech had to file an amendment to its application for non small cell lung cancer, which now requires more time for review. The news is a modest setback for Clovis, which has been involved in a major R&D showdown with AstraZeneca ($AZN). Release

> Highlighting progress in the pipeline, Alkermes ($ALKS) has launched pivotal studies for two key drugs and announced positive results for its depression drug ALKS 5461. Release

> Jay Bradner, the Harvard luminary set to take over Novartis' ($NVS) R&D operation next year, will be playing catch-up in immuno-oncology as the Swiss giant looks to cut in on a fast-growing market. News

> California biotech Hallux raised $7.1 million in Series A cash to support its mid-stage treatment for nail fungus. More

> Sage Therapeutics ($SAGE) said final results from its Phase III trial in a rare seizure disorder is on schedule to wrap up early, with top-line results now expected in the second half of next year. Release

Medical Device News

@FierceMedDev: Jury deals J&J $80M payout as a result of an injury from its defective hemorrhoid stapler. Article | Follow @FierceMedDev

@EmilyWFierce: U.K. cost watchdog gives one-two punch to Roche's Kadcyla and BMS' Opdivo. More | Follow @EmilyWFierce

> Developer of simple, procedural solution to sleep apnea finds commercialization partner. Story

> VA contracts with DARPA-backed startup for real-time behavioral analytics, mental health app. Article

Pharma News

@FiercePharma: FDA expands male age indication for Merck's Gardasil 9. More | Follow @FiercePharma

@EricPFierce: #EMA slams AstraZeneca for releasing APIs from India that repeatedly failed validation. Article | Follow @EricPFierce

@CarlyHFierce: J. Michael Pearson says it's a good thing everyone has TWO eyes - more available for cataract surgery. $VRX investor day so far. #pharma | Follow @CarlyHFierce

> U.K. cost watchdog gives one-two punch to Roche's Kadcyla and BMS' Opdivo. Story

> Mylan demands payback from Strides on plants targeted by FDA. More

Biotech Research News

> Penn researchers highlight role of CAP2 gene in cardiac arrest. Item

> MS program identifies a new pathway for drug developers. Story

> Roche bags a preclinical next-gen prostate cancer program in $142M deal. News

> Penn State team IDs a candidate for liver disease, obesity. Story

> An experimental class of drugs alters cell metabolism and may prevent tumor growth. Article

Vaccines News

> TSRI-led team tracks antibody origin, development in HIV vaccine work. Report

> GSK partners with Australian scientists to make cheaper pediatric vaccines. Item

> FDA accepts PaxVax's BLA for cholera vaccine, grants it priority review. More

> FDA expands male age indication for Merck's Gardasil 9. Story

> NIAID combines MedImmune, Sanofi H7N9 jabs into promising prime-boost vaccine. Article

Pharma Marketing News

> NICE rebuffs Roche's Kadcyla, BMS' Opdivo in latest round of cancer rejections. Article

> Remicade biosim may face an uphill battle with U.S. docs, analyst says. News

> Mr. Mucus-repped cough meds get the most positive buzz online. Story

> GSW's year-ahead forecast includes pricing debates, changing script models and informed patients. Report

> Pharma brands need the human touch, and MS marketing offers some ideas. Article

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