AC Immune weighs an IPO; Novartis plays catch-up in PD-1;

@FierceBiotech: FDA asks experts to weigh in on PCSK9 drugs' market reach for Amgen, Regeneron/Sanofi. Report | Follow @FierceBiotech

@JohnCFierce: If I set up a biotech, treated 4 patients with depression with ketamine and then touted the results, would people buy my stock? $SAGE | Follow @JohnCFierce

@DamianFierce: Excellent feature about ClickHole. And an excellent feature on ClickHole | Follow @DamianFierce

> AC Immune, awaiting word on whether partner Roche ($RHHBY) will move its Alzheimer's disease treatment into Phase III, is considering an IPO or outright sale, CEO Andrea Pfeifer says. More

> Despite trailing the likes of Merck ($MRK) and Bristol-Myers Squibb ($BMY) in the field of checkpoint inhibitors for cancer, Novartis believes it can catch up in a hurry thanks to a slew of acquisitions and licensing deals. News

> Canada's DalCor Pharmaceuticals is developing the Roche-abandoned heart drug dalcetrapib, betting it can succeed where its predecessor failed by homing in on patients with particular genetic mutations. Item

Medical Device News

@FierceMedDev: ICYMI from @StacyALawrence: Intarcia readies for FDA in 2016, reports detailed Ph III data for once-yearly diabetes implant. Report | Follow @FierceMedDev

@VarunSaxena2: ICYMI yesterday: Medtronic, BD to collaborate on diabetes infusion set featuring enhanced insulin delivery. Story | Follow @VarunSaxena2

> Medtronic launches bariatric surgery tool to enable more consistent procedures. Story

> Outset Medical rounds up $91M to make dialysis options more attractive. News

Pharma News

@FiercePharma: ICYMI yesterday: GSK's Advair dogged again as Mylan launches first bioequivalent copy in U.K. Article | Follow @FiercePharma

@EricPFierce: Mylan recalls more injected cancer drugs it made for Pfizer at its Agila plants in India. FiercePharmaManufacturing story | Follow @EricPFierce

@CarlyHFierce: Could an $18.9B Shire bid convince Actelion to ditch its independence? More | Follow @CarlyHFierce

> No red flags in Januvia heart study means a big win for Merck. Story

> U.S. poised to spend $50B on just 10 'breakthrough' meds in 10 years. Report

> Pfizer scientist warned execs about Zoloft and birth defects, lawyers say. Article

Drug Delivery News

> Research group seeks to promote crystals as drug delivery, development tools. More

> Implanted device releases drugs to help determine cancer-killing course of action. Item

> Sebacia raises $8M, nears FDA submission of laser-activated microparticles for acne. News

> Braeburn's once-rejected implant to treat opioid abuse shown comparable to pills in pivotal trial. Story

> India's Cipla gets first FDA approval of oral pellet to treat HIV/AIDS in infants. Report

Pharma Manufacturing News

> Serious manufacturing issues tied to fungal contamination in NIH facility. News

> Mylan picks 3M to manufacture its generic Advair inhaler for U.K. market. Item

> Cardinal Health targets hospital sales with $1.1B bid for Harvard Drug Group. More

> Mylan expands recall of cancer meds made for Pfizer. Report

> AstraZeneca's manufacturing gets another boost with $125M Africa plant. Story

Pharma Asia News

> India's Sun says slow and steady on Ranbaxy plants, FDA on Wockhardt at odds with management. Item

> Complaints trickle in about higher drug prices in China after cap removal. Report

> China's 3SBio returns to market and pulls in $710.7M in HK IPO. More

> GSK, Sanofi hauled up by India's competition watchdog on vaccine tenders. Story

> Australia's Proteomics claims first predictive diabetic kidney disease diagnostic test. Article

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