@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