People and Places in the News – January 2011
- By BSTQ Staff
FDA Approvals
Octapharma USA has received orphan drug exclusivity from the U.S. Food and Drug Administration (FDA) for Wilate (von Willebrand Factor/Factor VIII Concentrate, Human), the replacement therapy developed specifically for von Willebrand disease.
The FDA has approved a new onevial formulation of Sanofi-Aventis U.S. chemotherapeutic agent Taxotere (docetaxel) Injection Concentrate, which is available to cancer treatment clinics and hospitals nationwide in both 80 mg and 20 mg dosages. Introduced more than 14 years ago, Taxotere is approved by the FDA for use in treating patients at specific stages of five types of cancer, but it was previously available in only a two-vial formulation.
Pfizer Inc. has received 510(k) clearance by the FDA for its prefilled dual-chamber syringe used to reconstitute and administer antihemophilic factor (recombinant) plasma/albumin-free intravenous infusion (Xyntha) in patients with hemophilia A. The all-in-one syringe is the first to supply freeze-dried albuminfree recombinant factor VIII and also the diluent (0.9% sodium chloride), eliminating the reconstitution transfer step and improving patient convenience.
Fenwal Inc. has been given a new 510(k) clearance by the FDA for its Amicus blood cell separator. The new clearance involves the use of the Amicus separator with InterSol platelet additive solution, which Fenwal introduced earlier this year. InterSol is an electrolyte-based fluid that replaces 65 percent of the human plasma previously needed as a storage solution for donated platelets. Blood centers can collect the plasma replaced by InterSol and provide it to hospitals where it is used to treat patients.
Appointments
Tolerx Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T-cell activity, has appointed Antonin de Fougerolles, PhD, as chief scientific officer. Dr. de Fougerolles has 15 years of biotech research and development experience in immunology.
University of California, Irvine, professors Michael Cahalan, Greg Duncan and Susan Trumbore have been elected to the National Academy of Sciences. They are among 72 new members and 18 foreign associates from 14 countries chosen in recognition of their distinguished and continuing achievements in original research.