FDA cites Novartis unit for Indian manufacturing shortfalls; NICE stonewalls Celgene's Abraxane for pancreatic cancer;

@FiercePharma: Amgen's T-Vec wins FDA nod, EU committee recommendation. FierceVaccines story | Follow @FiercePharma

@EricPFierce: GSK says it 'takes seriously' issues at China plant that led UK regulators to pull GMP cert. More from FiercePharmaManufacturing | Follow @EricPFierce

@CarlyHFierce: Pfizer blows past sales forecasts, thanks to overachievers Prevnar, Ibrance. Story | Follow @CarlyHFierce

> The FDA warned Novartis' ($NVS) generics unit Sandoz of manufacturing violations at two of its plants in India, including one earmarked for closure in a global consolidation push. Report

> Celgene's ($CELG) Abraxane missed out on a cost-effectiveness nod in England for pancreatic cancer, with officials at the National Institute for Health and Care Excellence (NICE) saying its benefits don't justify the cost. Report

> The now-off-patent Alzheimer's drug Aricept (donepezil) may help patients delay moving into nursing homes, a study found. Report

> Belgium's UCB hiked its full-year financial outlook on strong growth of three of its new drugs--Cimzia, Vimpat and Neupro--and ongoing sales of its off-patent epilepsy med Keppra. Report

Medical Device News

@FierceMedDev: NEA backs cancer genome Dx startup Personal Genome in $21M+ Series A. More | Follow @FierceMedDev

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

@EmilyWFierce: "Leadership is about creating futures that are not a direct path." - @broadinstitute's COO Samantha Singer. More/Feature | Follow @EmilyWFierce

> J&J's Ethicon partners with Fogarty Institute to back next-gen device innovation. Report

> Medtronic touts studies of its devices to monitor patients following sedation. Story

> Cleveland Clinic, Candescent Health partner to create cloud-based radiology network. More

Biotech News

@FierceBiotech: Michigan investigators zero in on a new approach to a Notch cancer drug. FierceBiotechResearch story | Follow @FierceBiotech

@JohnCFierce: Following pioneering approval, Versant bankrolls next-gen oncolytics player Turnstone. Article | Follow @JohnCFierce

@DamianFierce: $MGNX gets the last laugh by misspelling "Servier" in its breakup announcement. Release | Follow @DamianFierce

> Servier severs a $450M oncology deal with MacroGenics. News

> Struggling Arena Pharma axes 80 jobs, narrows R&D. Item

> Intercept's much-hyped NASH drug misses the mark in Phase II. Article

Biotech Research News

> JAK inhibitors demonstrate fresh promise in restoring hair growth. Report

> Restoring testosterone production may be safer than replacement treatments. Item

> Howard Hughes researcher IDs a new target for autoimmune disease. More

> Michigan investigators zero in on a new approach to a Notch cancer drug. Story

> Drug-device combo from Wyss takes a new approach on treating stroke. Article

Pharma Marketing News

> Shire nabs much-needed PhIII boost for dry-eye prospect lifitegrast. Item

> Merck says it won't need AbbVie-sized discounts to win in hep C. Article

> With competition heating up, Pfizer may drop psoriasis effort on Xeljanz. Report

> Merck's Keytruda has a shot at a bigger share of NSCLC sales. Story

> No exodus from DPP-4s on Jardiance CV data, but SGLT2 scripts are shifting: Merck. More

Vaccines News

> GSK's malaria vaccine hits roadblock as WHO recommends pilot projects. News

> Pfizer continues vaccines hot streak with 43% Q3 growth. Report

> Amgen's T-Vec wins FDA nod, EU committee recommendation. Story

> GSK reports PhIII success for shingles jab, will file for approval in late 2016. Article

> SciVac Therapeutics agrees to acquire VBI Vaccines. Item

And Finally... More than three-fourths of Americans say the cost of prescription drugs for serious diseases is their chief health concern, a Kaiser Family Foundation poll found. Report

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