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Regulatory and Washington

  • Reports: Insurers, employers support YMCA diabetes program

    NEW YORK — The YMCA is sponsoring a diabetes-control program that some say could slow the disease's spread, according to published reports.

  • Reports: Florida House subcommittee approves biosimilar-substitution bill

    NEW YORK — A new bill in Florida's state legislature would allow pharmacists to substitute biosimilars for branded biotech drugs, according to published reports.

    The Sarasota Herald-Tribune reported that the Health Quality Subcommittee of the Florida House of Representatives approved a bill that would allow for substitution while requiring pharmacists to notify prescribing physicians within five days and require the doctor and pharmacist to maintain a record for at least four years.

  • Gilead voluntarily recalls one lot of injected AIDS-related infection drug

    FOSTER CITY, Calif. — Drug maker Gilead Sciences has recalled a single lot of an injected drug used to treat an opportunistic infection in AIDS patients due to the presence of foreign matter in some vials, the company said.

    Gilead announced the voluntary recall of lot B120217A of Vistide (cidofovir), an injected drug used to treat cytomegalovirus retinitis in patients with AIDS, due to particulate matter.

  • Anthem suspends controversial Calif. mail-order specialty pharmacy policy

    NEW YORK — Anthem Blue Cross will indefinitely suspend a policy that would require many specialty pharmacy patients in California, most of them HIV patients, to receive their drugs via mail order in order to receive coverage for them, drawing criticism from patients and retail pharmacies.

  • FDA approves Aurobindo diabetes drug

    HYDERABAD, India — The Food and Drug Administration has approved a generic diabetes drug made by Aurobindo Pharma, the drug maker said.

    Aurobindo announced the approval of pioglitazone tablets in the 15 mg, 30 mg and 45 mg strengths, in addition to the earlier tentative approval it received for pioglitazone and metformin hydrochloride tablets in the 15 mg/500 mg and 15 mg/850 mg strengths.

  • CDC: Flu activity drops to 3.2%, still above national baseline of 2.2%

    ATLANTA — For the week ended Feb. 9, influenza activity decreased to 3.2% — still above the baseline of 2.2%, but an indicator this year's flu season is on its way out. 

    Eleven states and New York City were still experiencing high influenza-like illness activity, while 10 states reported moderate activity.

  • FDA grants priority review to ViiV drug for HIV

    LONDON — The Food and Drug Administration has granted priority review to an experimental drug made by ViiV Healthcare for HIV, the company, a joint venture between British drug maker GlaxoSmithKline and American drug maker Pfizer, announced.

    The FDA gave the designation to dolutegravir, designed for use in combination with other antiretrovirual drugs in adults and adolescents. The agency gives priority review to drugs that offer significant improvement compared with products already on the market.

  • Study finds dramatic improvement in blood-sugar control among diabetes patients

    NEW YORK — Control of A1C, blood pressure and cholesterol among patients with diabetes has improved markedly, but more room for improvement remains, according to a new study.

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