FDA delays Opdivo decision; Axovant ups PhIII Alzheimer's costs to $135M;

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> Bristol-Myers Squibb ($BMY) says that the FDA is postponing its deadline for a marketing decision on Opdivo as a frontline treatment for melanoma. The new PDUFA date is November 27, giving regulators more time to review additional data filed to support the application. Release

> Axovant ($AXON) has upped the ante on its Phase III study of a new Alzheimer's drug obtained from GlaxoSmithKline ($GSK). The new estimate on the Phase III now reaches as high as $135 million, though the biotech still has plenty of cash available from its recent IPO. Axovant's share price has been falling steadily since its debut. Release

Medical Device News

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> 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

Pharma News

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@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

> Proxy advisers back Mylan's Perrigo quest as investor vote looms. Report

> Merck tallies 36,000 job cuts in 5 years of restructuring. Article

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

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