Spotlight On... FDA warning letter puts Ipca Labs under fire for widespread data manipulation; Lundbeck steps closer to new Rexulti use; Pernix eyes potential sale; Richter churns out a profit; and more...

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

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