Specialty Pharmacy

HAYWARD, Calif. — The branded subsidiary of Impax Labs has submitted a new drug application for its investigational idiopathic Parkinson's disease treatment to the Food and Drug Administration.

ALEXANDRIA, Va. — According to the National Community Pharmacists Association, changes governing long-term care facilities that recently were proposed by the Centers for Medicare and Medicaid Services could create turmoil for independent community pharmacies providing LTC services, the association stated in a release Wednesday.

CAMBRIDGE, Mass. — An orally administered drug made by Genzyme for treating multiple sclerosis did not appear superior to a biotech drug already on the market, according to results of a late-stage clinical trial.

Genzyme, owned by French drug maker Sanofi, compared the once-daily drug teriflunomide with Rebif (interferon beta-1a), made by Pfizer and Merck KGaA, in patients with relapsing MS in the 324-patient "TENERE" trial. Merck KGaA, based in Germany, operates under the name EMD Serono in the United States to avoid confusion with U.S.-based Merck & Co.

SILVER SPRING, Md. — The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

The FDA announced the approval of Merck's Isentress (raltegravir) for HIV-1 infection in patients ages 2 to 18 years. The chewable form of the drug will be available for children ages 2 to 11 years.

"Many young children and adolescents are living with HIV, and this approval provides an important additional option for their treatment," FDA Office of Antimicrobial Products director Edward Cox said.

NEW YORK — Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

The company said the FDA accepted a new drug application for tofacitinib for review. The agency also has provided an anticipated Prescription Drug User Fee Act action date of August 2012. Tofacitinib, which is a novel, oral JAK inhibitor, currently is under review by the European Medicines Agency.

PHOENIX — Specialty pharmacy provider The Apothecary Shops is encouraging medication adherence with a cap for pill containers that cues patients with lights and sounds, the company said.

PITTSBURGH — The World Health Organization has approved three generic second-line treatments for HIV made by Mylan, the drug maker said Tuesday. The drugs will be delivered to people in developing countries living with HIV and AIDS.

WINSTON-SALEM, N.C. — AstraZeneca and Targacept released results of the second of four phase-3 clinical trials that investigated the efficacy and tolerability of a drug that could serve as an adjunct therapy to major depressive disorder patients that had an inadequate response to initial antidepressant therapies.