Gen-Probe Incorporated has announced that Prodesse’s ProFlu-ST(TM) assay, a molecular test that detects the 2009 H1N1 influenza virus and differentiates it from two common seasonal strains, has received its CE Mark, enabling it to be commercialized in the European Union. The ProFlu-ST assay uses real-time RT-PCR (polymerase chain reaction) to detect and identify the 2009 H1N1 influenza virus, the seasonal influenza A/H1 virus, and the seasonal influenza A/H3 virus.

Asthmatx Inc. has announced that the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to the U.S. Food and Drug Administration (FDA) voted to recommend that the Alair® System, a device utilized in bronchial thermoplasty for the treatment of severe persistent asthma in patients 18 years and older, be found approvable with conditions. The final decision regarding the approval of the device is made by the FDA.

Scientists at University of California, Davis, have found that earlier exposure to the seasonal flu viruses provide people with some level of immunity to the 2009 H1N1 influenza virus. In their study, the researchers identified a group of immunologically important sites on the 2009 H1N1 influenza virus that are also present in other influenza viruses that have been circulating for years. The study has been published in the journal of Emerging Infectious Diseases.

Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Capsules (Sprinkle), 15 mg and 25 mg. Topiramate Capsules (Sprinkle) are the generic version of Ortho McNeil’s anticonvulsant Topamax® Sprinkle Capsules, 15 mg and 25 mg. Currently, Mylan has 121 ANDAs pending FDA approval representing $85.7 billion in annual brand sales, according to IMS Health.