Jazz shares spike on FDA staff review; Medtronic buys Osteotech for $123M;

 @FierceBiotech: Big Pharma takes on risk with biosimilar programs. Article | Follow @FierceBiotech

Special Report: The Top Counterfeit Drugs. Read now >>

> Shares of Jazz Pharmaceuticals spiked this morning on the news that FDA staffers gave its fibromyalgia drug a fairly clean bill of health going into an expert panel review at the end of the week. The drug Xyrem is already available for narcolepsy and includes an active ingredient often linked with date rape. Analysts told Bloomberg that the big question going into the review is how aggressive regulators may be laying out requirements for a follow-up REMS program. Story

> Medtronic has expanded its biologics division with a $123 million deal to purchase Osteotech, which is based in Eatontown, NJ. Osteotech's business focuses on healing bone injuries through surgical procedures and regenerative healing. And Medtronic execs hope the merger will foster accelerated technology discoveries. Report

> Woburn, MA-based Avantra Biosciences has raised $7 million in Series A cash. Report

> NephRx Corporation today announced that the FDA has granted orphan drug designation to its lead product NX001 for the prevention of delayed graft function (DGF) in renal transplant recipients. Release

And Finally... More and more children are suffering from hearing loss, and researchers say that the ubiquitous earbud device is primarily responsible. Report

Suggested Articles

MicuRx nabbed $7.78 million from a nonprofit focused on antimicrobial resistance to push its third antimicrobial program into human trials.

The FDA has placed a phase 1/2 trial of Passage Bio’s GM1 gene therapy on clinical hold pending further assessment of the risk of its delivery device.

VBL got the green light after the committee looked at unblinded overall survival data for the second pre-planned interim analysis.