Amgen, Cytokinetics cite success of PhII omecamtiv study; GW concedes Sativex flunked PhIII pain studies;

@FierceBiotech: GlaxoSmithKline's cardio R&D group records another big PhIII flop. News | Follow @FierceBiotech

@JohnCFierce: Kite Pharma taps Mitch Gold's upstart Alpine for T-cell immuno-tech. Article | Follow @JohnCFierce

> Amgen ($AMGN) and its partner Cytokinetics say their Phase II trial evaluating omecamtiv mecarbil in patients with chronic heart failure came through with some positive results among several measures of cardiac function. The companies didn't provide any details, but investigators say that posted "significant decreases in cardiac dimensions and heart rate in the dose-titration group," biomarkers on efficacy. Release

> GW Pharmaceuticals ($GWPH) says Sativex flunked the last two Phase III studies for pain, marking a complete failure in the late-stage effort. But GW isn't giving up. "In light of the missed primary endpoint in the first trial earlier this year, these additional results are not a surprise. Nevertheless, we are encouraged by data across the trials which consistently show positive outcomes for US patients when analyzed as a separate cohort," said GW Chief Executive Justin Gover. "We believe that this finding may provide important guidance in determining the optimal target patient population for Sativex and look forward to a discussion with the FDA on a potential path forward," Gover added. Story

> New Sanofi ($SNY) CEO Olivier Brandicourt will lay out his 5-year strategic plan on November 6, mapping his vision for the path forward following the ouster of Chris Viehbacher. Story

Medical Device News

@FierceMedDev: ICYMI: Healthcare, wellness drive Philips growth as it works to shed lighting. Report | Follow @FierceMedDev

@VarunSaxena2: ICYMI: J&J device heads say the new med tech innovation model calls for more external partnerships. Article | Follow @VarunSaxena2

@EmilyWFierce: Stanford scientists reveal artificial skin device for prosthetics. Story | Follow @EmilyWFierce

> Endologix off more than 25% on planned $211M merger with TriVascular. More

> NEA, Cleveland Clinic, Greatbatch back $20M Series A for neuromodulation heart failure startup. Story

Pharma News

@FiercePharma: Roche's O'Day says portfolio firing well in international markets, Japan a star. FiercePharmaAsia story | Follow @FiercePharma

@CarlyHFierce: "I've heard two CEOs use the word 'bold' in the last couple months..." - DB's Gilbert insinuating a $PFE $AGN tie-up. | Follow @CarlyHFierce

> Novartis shells out $390M to settle specialty pharmacy kickback claims. Report

> Bristol-Myers rides Opdivo, hep C sales to Q3 beat. More

> Senator slaps Valeant for sparse response on pricing decisions. Article

Pharma Manufacturing News

> U.K. cites the GSK China plant that was damaged by explosions. News

> Sun recalls 1M-plus boxes of generic Claritin made at Ohm Labs. Report

> Boehringer's Roxane plant mixes up APIs for blood pressure med. Story

> Lawsuit challenges Cipla's buyout of InvaGen. Item

> Spain's Grifols opening $100M warehouse, labeling operation in Dublin. Article

Drug Delivery News

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> 'Screen door' through blood-brain barrier gives Parkinson's drugs a way in. More

> Capsugel launches coating-free enteric protection delivery platform for oral meds. News

> FDA approval of Endo and BDSI's painkiller a win for buccal drug delivery. Item

> Flowonix to develop drug delivery implant for Cerebral's neurological candidates. Report

Pharma Asia News

> Tata Institute says paper shows 'early success' in malaria vaccine. More

> Indian health officials slam Lancet editor's comments. Article

> Lilly takes Q3 hits in emerging markets on FX, but Japan shows bright spots. Story

> Roche's O'Day says portfolio firing well in international markets, Japan a star. More

> China's ZAI Lab goes novel in drug development, makes key hire. Report