Specialty Pharmacy

Rather than take off for Christmas, the editors of Drug Store News took a look at the year ahead and the stories, issues and trends that will make headlines in retail pharmacy in 2012.

NEW YORK — Baxter and Momenta have agreed to partner to develop and market biosimilar  drugs to treat cancer, autoimmune disorders and other chronic conditions.

MOUNTAIN VIEW, Calif. — The Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee is set to review an investigational treatment for obesity.

Biopharmaceutical company Vivus said the panel will review its new drug application for Qnexa on Feb. 22, 2012.

Meanwhile, the FDA will complete its review of the NDA for Qnexa on April 17, 2012. The regulatory agency accepted the NDA in November after Vivus' resubmission of the NDA in October.

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.

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.