Tufts: Development timelines grow on biopharma drugs; Halozyme inks $83M Cinryze pact; Prexa raises $7M;

 @FierceBiotech: Can "backyard biotechs" beat Big Pharma at the development game? Report | Follow @FierceBiotech

 @JohnCFierce: This is exactly right. Scangos: "Biogen has been way too conservative, way too much like big pharma. Follow @JohnCFierce

> A new study from Tufts underscores the growing number of new biopharma drugs coming into the market. There were 65 new biopharma drugs approved from 2000 through 2009, compared to 39 for the decade before. But development time has grown as well, with the average time it takes to gain an approval jumping from 77 to 95 months. Report

> Boston-based Prexa Pharmaceuticals has garnered $7 million in a Series B. Advent Healthcare led the round. Story

> Halozyme snagged a $9 million upfront and promises of $74 million more in milestones from a licensing deal with ViroPharma covering development of a subcutaneous formulation of Cinryze. Halozyme release

> Alan Dove, contributing editor to Drug Discovery & Development, reports on efforts to break the barriers that separate laboratory successes in identifying biomarkers to actual validation and qualification in the clinic. Report

> A feature on the Canadian Institutes of Health Research's website (CIHR) notes that despite wonderful advances in medical science, "much of the practice of medicine remains imprecise" and people are treated with a one-size-fits-all regimen--especially when it comes to cancer. Unfortunately, cancer can be a very personalized affliction, and no two are necessarily the same in every patient. Enter biomarkers. Story

> Roche has filed for U.S. and European approval of vemurafenib (PLX4032/RG7204), a promising new melanoma drug initially developed at Plexxikon. Analysts give it good odds for success. "We expect a smooth approval process given the high unmet medical need and the compelling efficacy data in a personalised treatment approach," said Kepler Capital Markets analyst Martin Voegtli. Report

> BioLineRX and Cypress Bioscience have called off their development pact on a schizophrenia drug, BL-1010. Story

> Researchers at Uppsala University in Sweden have found a new, promising marker for diagnosing prostate cancer, hopefully leading to fewer "false positives" that plague current methods of diagnosis. Article

> UCSF is looking for parters for breast cancer biomarker research. Item

> Shares of InterMune ($ITMN) plunged yesterday after the company's largest institutional shareholder said it was considering selling its shares in the biotech company. Report

> The CRO Quintiles is on the hunt for $2.23 billion in loans to complete a refinancing. Report

> Those who suffer from, or study, Type 2 diabetes might know a little about beta cells. Located in the pancreas, they are responsible for producing and releasing insulin. If, for some reason, something goes haywire in the ability of beta cells to function, the result is the body losing its ability to control blood sugar, resulting in diabetes. The Foundation for the National Institutes of Health is embarking on a multiyear search for better tools that measure the function of beta cells in the hopes of coming up with better ways of tracking the progression of diabetes. Story

> Sosei will pay BioAlliance an upfront license fee of $3 million and further development and sales-based milestones totaling up to a maximum of $18.5 million in exchange for development and commercialization rights to Loramyc. Sosei release

> Neoprobe CEO Mark Pykett rejected criticisms leveled at the company's study of the radiopharmaceutical Lymphoseek. Report

Pharma News

@FiercePharma: Lighter on sales reps, Big Pharma goes digital. Report | Follow @FiercePharma

> Sanofi eyes cost cuts and deals for vet unit. Article

> JAMA: Comparative heart study didn't change treatment. Story

> Novartis dismisses senior staffers for misconduct. Item

> Judge tosses charges against ex-GSK lawyer. News

Drug Delivery News

> Researchers engineer self-assembling micelles for drug delivery. Report

> Aegis, Albany Medical College use pregnancy-produced protein against breast cancer. Article

> Macrophages go backpacking to deliver drugs. Item

> Upgraded T-cells take no prisoners, kill tumors. Story

Medical Device News

> Private equity firm urges FDA to investigate 3M. Report

> Medtronic taps Omar Ishrak as new CEO. Article

> Report: Medtronic makes big job cuts in diabetes unit. Story

> Edwards Lifesciences encouraged by valve system study results. Report

> FDA asks companies for studies of artificial hips. Item

And Finally... Geron has recruited its second patient for a pioneering embryonic stem cell therapy for spinal cord damage. Report

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