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Regulatory and Washington

  • CDC issues report on flu activity in the United States

    ATLANTA — Influenza activity in the United States decreased across several indicators, the Centers for Disease Control and Prevention reported Friday, though the agency projected that illness rates for the season have not yet peaked.

    Of all influenza A viruses tested since Oct. 30, 2010, only 15.8% were identified as the 2009 H1N1 virus; 44.6% of the specimens were identified as an H3N2 virus. That virus is similar to the H3N2 component of the 2010-2011 triumvirate influenza vaccine.

  • Dr. Reddy's receives FDA approval for generic GERD treatment

    HYDERABAD, India — Indian drug maker Dr. Reddy’s Labs has launched a generic treatment for gastroesophageal reflux disease.

    The company announced Thursday the launch of pantoprazole sodium delayed-release tablets in the 20-mg and 40-mg strengths. The drug is a version of Protonix, made by Wyeth, now part of Pfizer.

    Pantoprazole sodium delayed-release tablets had sales of around $1.8 billion during the 12-month period ended in September 2010, according to IMS Health.

  • Obesity and its toll are soaring, CDC says

    ATLANTA — Obesity rates continue to soar among the U.S. population, particularly in children. And the result, the Centers for Disease Control and Prevention reported, leads both to “psychosocial problems and to cardiovascular risk factors, such as hypertension, high cholesterol and abnormal glucose tolerance or diabetes.”

  • Under PEPFAR, Matrix gets tentative approval for generic Combivir

    PITTSBURGH — The Food and Drug Administration has given tentative approval to an antiretroviral treatment for children with HIV and AIDS under the President’s Emergency Plan for AIDS Relief program.

    Mylan announced Thursday that its subsidiary, Matrix Labs, had received the tentative approval for lamivudine and zidovudine tablets in the 30-mg/60-mg strength. The drug is a generic version of Combivir, made by ViiV Healthcare, a company specializing in HIV and AIDS created as a partnership between Pfizer and GlaxoSmithKline.

  • MannKind receives complete response letter for Afrezza

    VALENCIA, Calif. — It seems that MannKind has experienced a setback with a drug designed to control hyperglycemia in Type 1 and Type 2 diabetes patients.

    The Food and Drug Administration on Thursday issued a complete response letter to the drug maker regarding Afrezza (insulin human [rDNA origin]) inhalation powder. The regulatory agency requested that the company conduct two clinical trials, one in patients with Type 1 diabetes and one in patients with Type 2 diabetes, with its next-generation inhaler, to assure it works as effectively as MedTone, its predecessor.

  • Vertex's hepatitis C drug granted priority review by FDA, Health Canada

    CAMBRIDGE, Mass. — The Food and Drug Administration and Health Canada have granted priority review to a drug for treating hepatitis C.

    Vertex Pharmaceuticals announced Thursday that the two agencies had given the designation to telaprevir for treating patients with chronic infections.

  • Surgeon general issues call to action around breast-feeding

    WASHINGTON — Surgeon general Regina Benjamin on Thursday issued a “Call to Action to Support Breast-feeding,” outlining steps that can be taken to remove some of the obstacles faced by women who want to breast-feed their babies.

  • Genentech: Advanced skin cancer treatment boosts survival rate

    SOUTH SAN FRANCISCO, Calif. — Patients taking an investigational drug made by Genentech for advanced skin cancer fared better than those receiving standard treatments, according to results of a late-stage clinical trial announced Wednesday.

    The company, part of Swiss drug maker Roche, said patients with advanced melanoma containing a mutated version of a protein called BRAF lived longer when receiving the orally administered personalized investigational medicine RG7204 than those receiving the injected chemotherapy drug dacarbazine.

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