/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...
NEWS

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...

FiercePharma
2016/02/09

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 M****anufacturing 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

Summary

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...