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

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