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The FDA has approved Auxilium Pharmaceuticals’ Xiaflex biologic injection for Peyronie’s disease, a deformity of the penis caused by a lump of plaque that results in a curvature of at least 30 degrees. Read More
Valencia, Calif.-based SetPoint Medical has hired Sagentia to develop a programming interface for a neuromodulation device designed to provide a lower-cost and lower-risk alternative to immunosuppressive drugs such as prednisone that treat chronic inflammatory diseases such as Crohn’s disease and rheumatoid arthritis. Read More
The European Commission Dec. 5 granted AstraZeneca (AZ) European marketing permission for its Fluenz Tetra live attenuated intranasal influenza vaccine for patients age 2 to 18. The vaccine is sprayed into each nostril, where its weakened viral strains induce protective immunity. Read More
Oculus Innovative Sciences has received 510(k) clearance for its Microcyn hydrogel for scars resulting from burns, surgery or trauma wounds, with the FDA recognizing the device as substantially equivalent to similar products. Read More
Dyax’s DX-2930, an experimental treatment for hereditary angioedema, has won FDA orphan drug designation. The human monoclonal antibody is designed to inhibit plasma kallikrein to reduce swelling, pain and inflammation associated with the disease, the drugmaker says. Read More
The FDA has granted Japan’s Sumitomo Heavy Industries its first 510(k) clearance for a 23 MeV cyclotron proton beam radiation therapy device that targets cancer cells. Read More
In a boost for Big Pharma, the European Medicines Agency (EMA) has raised the fee-reduction rate for non-small and medium-sized enterprises (SMEs) seeking assistance on non-pediatric-related protocol from 40 percent to 75 percent, in line with recommendations by the agency’s orphan medicinal products panel. Read More
The Drug Enforcement Administration has placed Eisai's seizure medication Fycompa into schedule III of the Controlled Substances Act, clearing the final regulatory hurdle on the drug's pathway to market. Read More
Washington, D.C.-based MedStar Health has signed a deal licensing to InnoVital Systems the intellectual property rights to the artificial muscle technology that it hopes will power the InVent diaphragm assist device. Read More
The FDA has notified Biogen Idec that it needs more time to review its BLA for Alprolix after the drugmaker submitted additional data supporting the validation of a key manufacturing step. Read More