@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
> Palo Alto, CA-based Orbus Therapeutics has raised $32.5 million in an A round from Longitude Capital, H.I.G. BioVentures and Adams Street Partners. Dr. Ernest Mario also participated in the round, taking the chairman's job. He is chairman of Capnia and Chimerix and was formerly deputy chairman of Glaxo. The money is earmarked for a Phase III study of eflornithine, which has a breakthrough drug designation for anaplastic glioma. Release
> After cutting tens of thousands of employees company-wide, union workers at one of Merck's ($MRK) campuses in Pennsylvania say that they've been forced to work 16-hour shifts, causing dangerous conditions for fatigued staffers. 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
Pharma News
@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
> Merck job-cutting tensions displayed in public emails from Frazier, union rep. News
> Merck's Januvia powerhouse could feel the heat from device challenger. 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