Specialty Pharmacy

WESTON, Mass. — The Food and Drug Administration has approved two separate dosing innovations for multiple sclerosis patients that are being treated with a Biogen Idec drug.

Biogen Idec said the FDA approved Avonex pen, the first single-use, once-weekly intramuscular autoinjector approved for MS, and a dose titration regimen, which gradually escalates the dose of Avonex at treatment initiation. The drug maker said the new offerings are designed to improve the treatment experience.

PARSIPPANY, N.J. — Lowering health costs will require a greater understanding of differences between two distinct groups of patients, according to a new study, which also noted a growing availability of specialty drugs for complex and chronic conditions outside the hospital.

PHOENIX — A division of specialty pharmacy provider The Apothecary Shops has become the exclusive distributor of a drug used in glaucoma surgery, the company said.

Apothecary Shop Wholesale has received exclusive distribution rights for Mobius Therapeutics' drug Mitosol (mitomycin), which the Food and Drug Administration approved earlier this month.

DEERFIELD, Ill. — Walgreens Specialty Pharmacy on Thursday released data showing that both patients and their health plans can realize savings of up to 60% on the cost of infused specialty medications by choosing alternate treatment sites. The cost savings was the key finding from new data being presented at the 2012 Pharmacy Benefit Management Institute Annual Drug Benefit Conference in Scottsdale, Ariz.


PITTSBURGH — The Food and Drug Administration has given tentative approval to a division of Mylan for a generic drug for treating HIV and AIDS in children in developing countries.

Mylan said Thursday that the FDA had tentatively approved Mylan Labs' abacavir sulfate and lamivudine tablets in the 60 mg/30 mg strength. The drug is a generic version of Viiv Healthcare's Epzicom and was approved under the President's Emergency Plan for AIDS Relief. The drug will only be available for purchase in certain developing countries outside the United States.

SOUDERTON, Pa. — A Northern Ireland pharmaceutical company has acquired a chemotherapy agent from Gilead.

Galen said it has acquired DaunoXome (daunorubicin citrate liposome injection), an anthracycline chemotherapy agent that was first approved in the United States in 1996, and is indicated as a first-line cytotoxic therapy for advanced HIV-associated Kaposi’s sarcoma. Galen said its wholly owned subsidiary, Galen US, will market the drug in the United States. DaunoXome will be made available through wholesalers in the United States.

HAYWARD, Calif. — The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.

Impax Pharmaceuticals, the branded products division of Impax Labs, said it filed its NDA for the investigational drug IPX066, an extended-release capsule formulation of carbidopa-levodopa, for review in December 2011. IPX066 has been licensed to GlaxoSmithKline for countries outside the United States and Taiwan for development and marketing.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.

The FDA announced the approval of Menlo Park, Calif.-based Corcept Therapeutics' Korlym (mifepristone) for endogenous Cushing's syndrome, a disorder that results from overproduction of cortisol, a steroid hormone that increases blood-sugar levels.