@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