@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
> 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
@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
Pharma News
@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
> 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