FDA inspectors have cracked down on data manipulation and falsification at a number of manufacturing facilities in India, but a new warning letter for three Ipca Laboratories plants shows the problem was rampant there--and enforced by senior managers in the quality-control unit to keep product supply flowing. More from FiercePharmaManufacturing
@FiercePharma: Omega diet-aid ad banned in U.K.; summer slimming promos not 'socially responsible.' FiercePharmaMarketing article | Follow @FiercePharma
@CarlyHFierce: All I want is to hear two people pronounce "Praluent" the same way. $REGN | Follow @CarlyHFierce
> Denmark's Lundbeck said the FDA has accepted its application for expanded labeling on its schizophrenia and depression med Rexulti. Report
> Specialty drugmaker Pernix Therapeutics ($PTX) is exploring a potential sale and tapped Perella Weinberg Partners to do the review, sources tell Reuters. Report
> The Hungarian pharma Richter delivered a fourth-quarter profit on lower costs, despite a decline in revenue. Report
> A parliamentary committee in England took issue with the management of the National Health Service's Cancer Drug Fund. Report
Medical Device News
@FierceMedDev: Sientra resumes U.S. sales of breast implants after Brazil manufacturing fallout. Report | Follow @FierceMedDev
@EmilyWFierce: ICYMI from FiercePharma: PhRMA kicks off new ad campaign to doctor pharma's tarred image. Article | Follow @EmilyWFierce
> BTG, Philips roll out first cancer embolic bead visible via real-time imaging. Report
> CMS backtracks, gives Boston Sci favorable reimbursement for its stroke-fighting Watchman. Article
Biotech News
@FierceBiotech: Amplyx ups its B round to $49.2M on the way to the clinical with an antifungal drug. Article | Follow @FierceBiotech
@JohnCFierce: Are the big M&A players in biopharma (like Sanofi/Gilead/Biogen) waiting out the bear market? More | Follow @JohnCFierce
@DamianFierce: Thesis of this BIO thing is that you can't put $ on life, but doesn't pricing onco drugs based on OS do just that? | Follow @DamianFierce
> Apellis pulls its IPO as biotech bears rampage on Wall Street. Item
> OrbiMed founder preaches patience amid a biotech slump. Report
> In wake of $1B Celgene deal, Juno sweetens 2015 bonuses for CEO, CFO. Article
Pharma Manufacturing News
> Plant to manufacture yellow fever jab slated for Dakar. More
> FDA quality focus will definitely mean winners and losers, report says. Report
> Dr. Reddy's grows U.S. sales even in face of FDA action. Story
> Report says CMOs without U.S. facilities risk being left out of 'hot' market. Item
> Strides Shasun deals adds seventh plant to its African production network. Article
Pharma Asia News
> China Resources Pharmaceutical plans HK IPO. News
> Taiwan's outgoing leader touts biotech growth. Story
> Japan's Eisai surprises with API move. Item
> Japan continues to see generics as way to ease healthcare costs. Report
> Novo says China price pressures may go into 2017. Article
Drug Delivery News
> 'Crystal balls' in drug delivery could be stronger than liposomes. More
> Novartis signs with France's MedinCell for controlled-release injection tech. Story
> FDA says drug delivery devices need human factors validation testing. Item
> Struggling Unilife extends negotiating period with Amgen over partial takeover. Report
> Scilex aims to dethrone Endo in billion-dollar pain subsegment using novel transdermal patch. Article
And Finally... Scientists found a "musical room" in the brain, where a distinct set of neurons fire in response to music, but not to other types of sound. Report