FDA puts off new Opdivo use but beefs up Sprycel's label; Bayer taps top execs for plastics spinoff;

@FiercePharma: OSU researchers point to vaccine-free flu protection. FierceVaccines story | Follow @FiercePharma

@EricPFierce: This is the last time Novartis will be in the top 5 of this list. FierceVaccines feature | Follow @EricPFierce

@CarlyHFierce: Fun things brewing ... for me. $HZNP PLC sends letter to $DEPO Inc board of directors. Release | Follow @CarlyHFierce

> The FDA put off its decision on a big new use for Bristol-Myers Squibb's ($BMY) new immunotherapy Opdivo, after the company submitted new data in patients with previously untreated melanoma. Release

> Bristol-Myers won a labeling update for its blood cancer drug Sprycel as the FDA approved adding new 5- and 7-year efficacy and safety data on the drug's performance in certain patients with newly diagnosed chronic myeloid leukemia. Release

> Bayer moved another step closer to its planned plastics spinoff, to be named Covestro, with board approval for newly named CEO Patrick Thomas and CFO Frank Lutz. Release

> Denmark-based Lundbeck said it would increase its focus on the Chinese market, aiming to offer the widest range of CNS-related products in the country. Report

> Rising drug costs and their effect on veterans' healthcare plans are holding up negotiations on the Department of Defense's $620 billion budget. Report

Medical Device News

@FierceMedDev: Invitae gears up for next chapter with genome management aspirations. FierceDiagnostics story | Follow @FierceMedDev

@VarunSaxena2: ICYMI: Google joins forces with Dexcom for miniaturized glucose monitor. Article | Follow @VarunSaxena2

@EmilyWFierce: Journalist fights Amgen subpoena in Aranesp class action suit. More from FiercePharma | Follow @EmilyWFierce

> Bad news in California: Boston Sci to close to two facilities, Abbott cuts 160+ employees. Story

> Senseonics nabs $20M in venture funding for its implantable blood glucose monitor. Article

Biotech News

@FierceBiotech: FierceBiotech Radio on Amarin's First Amendment crusade, Martin Shkreli's Twitter, and Kim Kardashian's Instagram. Listen/Subscribe | Follow @FierceBiotech

@JohnCFierce: Struggling GlobeImmune brings in financial advisers as options dwindle. Report | Follow @JohnCFierce

> Roche bags antibiotics diagnostics tech in $425M GeneWeave buyout. Story

> Immuno-oncology deal frenzy continues as Merck partners with MD Anderson. Article

> Pfizer, OrbiMed back $40M Rhythm round for rare genetic disease R&D. Report

Vaccines News

> CMC Biologics to manufacture antibodies for Malaria Vaccines Initiative. More

> Chorus grows for reform in vaccine development process. Report

> CSL reports record $1.4B profit following Novartis flu vaccine purchase. Item

> Novavax reports positive top-line data from PhII trial of RSV vaccine. Story

> MedImmune offers up $727M to get its hands on Inovio HPV cancer vaccine. Article

CRO News

> Accelovance adding 70 jobs in Wales after a big EU buy. More

> INC's backers line up for a big Wall Street payday. Item

> WuXi advances edible bar codes, a novel approach to counter-counterfeiting. Report

> Another Indian CRO draws the ire of Western regulators. Article

> Chiltern buys Theorem to compete with CRO heavyweights. Story

Pharma Manufacturing News

> Australian pharma group says high manufacturing costs killing drug exports. Item

> Claris returns generic Lasix to market after clearing supply hurdle. More

> Chinese plant banned by EU, getting compliance help from NJ company. Report

> Sun sales, earnings pummeled by plant problems, integration costs. Story

> GSK site affected by Legionella bacteria expected to reopen in a few days. Article

Pharma Asia News

> India's Sun sees sharp Q1 profit drop, but Shanghvi not worried. More

> Pharma M&A, investment in Russia leading to exports, RBC Daily says. Article

> India's IP policies suit South Africa just fine, official says, wants New Delhi to hold the line. Story

> Opposition grows in Malaysia and New Zealand on TPP drug provisions. Report

And Finally... Listening to music before, during and after surgery cut patients' need for pain medication and eased anxiety, a study found. Report

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