FDA review questions safety, efficacy data on Hemispherx drug; Amgen inks third license on ImmunoGen tech; MedImmune in-licenses Progenics program;

 @FierceBiotech: Oncothyreon routed after Merck KGaA's Stimuvax flops in big PhIII lung cancer trial. Story | Follow @FierceBiotech

@JohnCFierce: Ex-GSK scientists grab $18M, neurosciences portfolio for startup. News | Follow @JohnCFierce

@RyanMFierce: Bristol-Myers' Sigal outshines pharma rivals in R&D chief ranking. (Does Jeremy Levin deserve some credit?) More | Follow @RyanMFierce

> Ahead of tomorrow's FDA panel review of Hemispherx's chronic fatigue syndrome drug, an agency review questioned the quality of its safety data and raised "multiple concerns with the efficacy analyses for the Ampligen program." Story

> Amgen ($AMGN) has licensed the exclusive right to use ImmunoGen's ($IMGN) maytansinoid TAP technology to develop anticancer therapeutics to a third target. Each license is worth a $1 million upfront fee and up to $34 million in potential milestones. Release

> MedImmune has signed an in-licensing agreement with Progenics Pharmaceuticals for Progenics' Clostridium difficile late-stage preclinical program.  Release

> Mark L. Perry and Uday N. Kumar have joined Third Rock as entrepreneurs-in-residence in the firm's West Coast office. Release

Pharma News

@FiercePharma: Lagging Lundbeck cuts its financial outlook for 2013 + 2014, on European sluggishness, R&D costs. More | Follow @FiercePharma

> Actavis CEO's next act may be a Stada buyout. Article

> Pfizer targets 600 primary-care sales jobs. News

Medical Device News

 @FierceMedDev: Nanotech transforms blood tumor cells into viable Dx tool. News | Follow @FierceMedDev

@MarkHFierce: Smith & Nephew vs. ConvaTec over a wound dressing patent issue; ConvaTec won. Report | Follow @MarkHFierce

 @DamianFierce: Privately held CardiacAssist is targeting the heart pump market after getting FDA OK for a pivotal trial. Story | Follow @DamianFierce

> Angel Medical pulls in $27.5M to fuel U.S. heart monitor trial. Article

> Report: Nonvascular ablation use poised to soar. Item

Drug Delivery News

> Helix and Merck terminate topical interferon collaboration. Article

> Langer nanoparticle startup Blend bags $16M funding and new CEO. News

> Unigene's oral bone drug doesn't give women the needle. Story

> Drugs sneak through the skin without patches. Item

Biomarkers News

> Myriad to peruse Sanofi insulin trial samples for biomarker clues. Report

> Merck turns to GE agent to track potential Alzheimer's biomarker. Article

> MIT's nanoparticles make cancer biomarkers more visible. News

> Protein doubles as diagnostic and drug target for blood cancer. Story

> SynapDx snags $6M for autism Dx study. Item

And Finally… Scientists at the University of Manchester say they have solved one of the big riddles in cancer drug research. They have been studying why new drugs called MEK inhibitors, which are currently in clinical trials, aren't as effective at killing cancer cells as they should be. They discovered that MITF, a protein that helps cells to produce pigment but also helps melanoma cells to grow and survive, is able to provide cancer cells with a resistance to MEK inhibitors. Release

 

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