Boehringer nabs label boost for cancer med Giotrif; Par, Concordia settle with FTC; Merck pulls 276K Temodar bottles;

@FiercePharma: Troubled Lundbeck targets 1,000 layoffs in HQ, commercial revamp. News | Follow @FiercePharma

@EricPFierce: FDA warning letter castigates three Mylan sterile drug plants in India. FiercePharmaManufacturing story | Follow @EricPFierce

@CarlyHFierce: In case you missed my foray into Google Forms, we're doing a survey on the next M&A move from $AGN. More | Follow @CarlyHFierce

> European regulators recommended a label update for Boehringer Ingelheim's lung cancer drug Giotrif to cite a one-year overall survival benefit in a study in patients with a certain EGFR mutation, compared with chemotherapy. Release

> Concordia Pharmaceuticals and Par Pharmaceutical settled charges of anti-competitive behavior leveled by the Federal Trade Commission, over an agreement not to compete sell rival generic versions of the ADHD drug Kapvay. Report

> Merck & Co. ($MRK) recalled 276,000 bottles of its chemotherapy drug branded and generic Temodar over cracks in child-proof caps. Report

> India's commerce ministry may set up a think-tank to help India reverse a slowdown in pharma exports. Report

> Liver damage in hepatitis C patients may be grossly underestimated and underdiagnosed, a new study found, suggesting that more people should be eligible for treatment with next-gen drugs, despite worries about their prices. Report

Medical Device News

@FierceMedDev: Guardant Health teams with Flatiron for liquid biopsy-based drug development platform. FierceDiagnostics story | Follow @FierceMedDev

@VarunSaxena2: Researchers develop probe for whole-body detection of blood clots using PET imaging. Article | Follow @VarunSaxena2

@EmilyWFierce: Genalyte ropes in $44M for microchip blood testing system. Press release | Follow @EmilyWFierce

> FDA launches pilot to experiment with common, global submission format. More

> Reuters: Medical funding industry gets boost from vaginal mesh litigation. Article

Biotech News

@FierceBiotech: FDA clears a controversial female libido drug despite 'modest' effects and dangerous risks. Story | Follow @FierceBiotech

@JohnCFierce: OpEd: The FDA blundered badly on the Addyi approval. Report | Follow @JohnCFierce

@DamianFierce: When I was kid you could buy one of these for just $67.5 million. More | Follow @DamianFierce

> Intarcia's diabetes-treating implant tops Januvia in a head-to-head test. Story

> Lundbeck is canning 1,000 workers with an eye on profitability. Article

Biotech Research News

> Harvard/MIT group sees promise of a targeted IBD drug delivery tech. Article

> Is the biomedical research system broken? Johns Hopkins says yes. Report

> Study: Eyes may signal brain pathology in schizophrenia. Story

> MD Anderson spotlights role of cytokine in tumor progression. Item

> Johns Hopkins team uses zebrafish to develop a new drug screening tech. More

Diagnostics News

> FDA clears NOWDiagnostics' drop-of-blood test for early detection of pregnancy. Report

> Guardant Health teams with Flatiron for liquid biopsy-based drug development platform. More

> FDA clears NOWDiagnostics' drop-of-blood test for early detection of pregnancy. Story

> Genalyte ropes in $44M for microchip blood testing system. Item

> Myriad snags Medicare coverage for prostate cancer test. Article

Pharma Marketing News

> A COPD outcomes trial could give GSK a $3B-plus Breo boost--or not. Article

> FDA to Sprout: Forget advertising your sex-drive med till 2017. Report

> Amgen to shell out $71M to states in Aranesp, Enbrel off-label settlement. Story

> Will pricey new drug classes take the wind out of diabetes launches? More

> Vyvanse set to steal ADHD share in back-to-school meds rush. Article

And Finally... A naloxone-dispensing clinic in Northern Kentucky helped change people's minds in favor of providing the opioid-overdose drug. Report

Suggested Articles

Former Indivior CEO Shaun Thaxter will face six months in federal prison for his role in misleading government officials on the dangers of Suboxone.

As of Friday after local time, 36 people have died in Korea after getting flu shots provided by at least seven companies, including Sanofi.

Two prominent pneumococcal vaccines from Merck and Pfizer are running low in Europe in a possible ill omen for the coming winter: report.