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.

LG launched a new range of air purifiers, combining effectiveness, convenience, portability and quiet operation. Combining five different air cleaning technologies and a 16 stage multi-layer filtering system, the new air purifier eliminates fine dust, bacteria, asbestos, amonia, formaldehyde, animal hair, allergy causing germs, mold, smoke, strong odors, and Nitrogen Dioxide. LG air purifier helps eliminating toxic gases emitted from cement, timber, insulating material, paint, home decoration as wall paper, rugs, curtains etc.

Researchers of the University of Santo Tomas in Manila, Philippines indicated that the monoclonal antibody belimumab (Benlysta), which is under investigation, was safe and effective for patients with systemic lupus erythematosus in a Phase III trial. After one year of treatment, belimumab reduced disease activity, flare rates and the use of prednisone, while increasing the time to a first flare.

Researchers from Harvard have reported that it may not be cost effective to include boys in a human papillomavirus (HPV) vaccination program. The details of this study were published online in the British Medical Journal on October 8, 2009. The goal of the current study was to assess the cost effectiveness of routinely vaccinating preadolescent boys, as is recommended in girls. These authors suggested that cost effectiveness of vaccinating both boys and girls would improve if the vaccine gave life-long protection against all HPV-related diseases or if the cost of vaccination fell. These authors concluded that “including boys in an HPV vaccination program generally exceeds conventional thresholds of good value for money, even under favorable conditions of vaccine protection and health benefits.”

French biotech firm NicOx has submitted a new drug application (NDA) to the US regulatory authority for its anti-inflammatory drug naproxcinod. The naproxcinod drug is developed for the treatment of osteoarthritis. The marketing approval of the drug could deal a blow to sales of the Pfizer medicine Celebrex. The company also plans to submit a Marketing Authorization Application (MAA) for naproxcinod to the European Medicines Agency (EMEA) in the fourth quarter of 2009.

The FDA has approved a new biologic drug called Stelara for the treatment of moderate to severe plaque psoriasis in adults. Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. According to the FDA, about 6 million people in the US have plaque psoriasis, which is characterized by thickened patches of inflamed, red skin, often covered with silvery scales.

The FDA Vaccines and Related Biological Products Advisory Committee agreed on the efficacy, immunogenicity and safety data of Merck & Co Inc’s . The clinical trials support the use of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for boys and men aged 9 to 26 years for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11.