Regulators skeptical of Teva drug's ability to slow Parkinson's; Dry powder tech company blueprints expansion, 100 new jobs

@FierceBiotech: Amgen signals looming restructuring of R&D operations. News | Follow @FierceBiotech

@ JohnCFierce: Just off the phone with Vertex's Peter Mueller. Asked him about his thoughts on early-stage development. He laughed and turned on the fire hose of ideas. This is going to be a fun discussion next Wednesday. | Follow @JohnCFierce

@RyanMFierce: After reading @FierceMedDev's 5 emerging medtech firms report, a Fierce 15 in medical devices makes even more sense. Report | Follow @RyanMFierce

> Teva's ($TEVA) attempt to land a new indication for Azilect for slowing the progress of Parkinson's has run into some high-level skepticism at the FDA. In newly released documents regulators queried the trial designs and data. One reviewer noted that: "There is no demonstrated benefit of rasagiline (Azilect's generic name) for slowing the rate of progression of Parkinson's Disease." Story

> Engineered Biopharmaceuticals, which is working on dry powder versions of drugs, is relying on a pair of grants to expand and create up to 100 jobs. Report

> Transgene reports that it is redesigning a clinical study of its hepatitis C vaccine after three patients in the study developed blood disorders. "A possible relationship with TG4040 cannot be today formally ruled out and is under active investigation," the company noted. Item

> Troubled Intercell got a chance to announce some upbeat news yesterday, noting that it will launch a confirmatory efficacy study of its pseudomonas aeruginosa vaccine with Novartis ($NVS). News

> Sequenom says it will create 242 new jobs when it builds a new lab in Research Triangle Park as it develops a screening test for Down syndrome. Story

> Oncobiologics of Cranbury, NJ, says it has inked a pair of deals worth up to $80 million. It closed deals with a startup called Parilis Biopharmaceuticals as well as an unnamed "US based large pharmaceutical company." Release

Pharma News

@FiercePharma: Sen. Kohl introduces drug-spending bill. Includes applying Medicaid rebates to Medicare Part B to save up to $44B. Report | Follow @FiercePharma

> Private equity looks for $905M in sale of Japan's Showa. Story

> Kohl backs drug-spending cuts focused on Medicare Part B. Item

> Ipsen weighs strategies for Russian growth. Report

> Weak cancer meds, Tamiflu take bite out of Roche sales. More

Vaccines News

> Michael J. Fox Foundation bankrolls AFFiRiS Parkinson's vaccine. Article

> CA law lets tweens make HPV vaccination decisions. News

> Inovio, VGX ink hep B and C vaccine deal. Item

> HepB vax Heplisav posts positive Ph3 data. Story

> Coridon HSV-2 vaccine shows 100% efficacy. Report

Manufacturing News

> Pain patch maker warned by FDA over validation reporting. Item

> Genzyme's Ireland site expanded. Article

> Teva walloped $163M in hepC ruling, doc 'unfit' for trial. Report

> China assesses illegal drug activities. Story

> Ex-Genzyme ops chief joins board at bio start-up. News

> Survey: Disposables adoption stymied by lack of standards. Article

And Finally... A team of investigators at the Broad Institute say they have pinpointed the parts of the human genome that control when and where genes are turned on. Release

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