Specialty Pharmacy

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare and aggressive type of blood cancer, the agency said Wednesday.

The FDA announced the approval of Imbruvica (ibrutinib), marketed by Pharmacyclics and Johnson & Johnson, for treating mantle cell lymphoma, or MCL. MCL is a rare form of non-Hodgkin lymphoma and represents about 6% of all non-Hodgkin lymphoma cases in the United States. Millennium Pharmaceuticals' Velcade (bortezomib) and Celgene's Revlimid (lenalidomide) are also approved for treating MCL.

WASHINGTON — The chairman of the Senate Health, Education, Labor and Pensions Committee highlighted the human tragedy wrought by last year's fungal meningitis outbreak linked to contaminated injectable steroids as he spoke in favor of a new law that would regulate compounding pharmacies and implement federal track-and-trace policies for drugs during a recent speech.

SAN DIEGO — The Food and Drug Administration has given special designation to a drug under development by Mast Therapeutics for a rare disease that restricts the flow of blood to the limbs.

NEW YORK — Johnson & Johnson and Pharmacyclics have added a New York-based specialty pharmacy company focused on cancer to their limited-distribution network for a drug recently approved for a rare form of blood cancer.

Onco360 said Wednesday that it had become part of the network for distributing Imbruvica (ibrutinib) capsules. The announcement came the same day that the Food and Drug Adminsitration announced the approval of Imbruvica (ibrutinib) for mantle cell lymphoma, or MCL.

LAKE FOREST, Ill. — Hospira had sales of $1 billion in third quarter 2013, the generic drug maker said.

Hospira, which specializes in making generic injectable drugs, as well as biosimilars for the European market, said the sales figures for the quarter were a 1.4% increase over the $994 million in sales reported in third quarter 2012. Profits for the quarter were $84.5 billion, compared with $78.4 billion during the same period last year.

ALEXANDRIA, Va. — The Specialty Pharmacy Certification Board has certified nearly 50 pharmacists following the first round of exams, the group said Monday.

The SPCB announced that 49 pharmacists had earned the Certified Specialty Pharmacist accreditation after taking the exams, which were administered in October, covering intake, fulfillment, clinical management and outcomes.

LOUISVILLE, Ky. — Electronic prescribing network Surescripts has certified PharMerica, a chain of specialty infusion and institutional pharmacies that serve long-term care centers, for receiving orders for controlled and non-controlled substances over the Surescripts network.

DUBLIN — Shire will pay $4.2 billion to buy a drug maker specializing in treatments for rare diseases.

Shire, headquartered in Ireland, said the $50-per-share acquisition of ViroPharma would strengthen its rare disease portfolio. Exton, Pa.-based ViroPharma's products include the hereditary angioedema drug Cinryze (C1 esterase inhibitor [human]) and Vancocin (vancomycin hydrochloride), used to treat Clostridium difficile-associated diarrhea.