Specialty Pharmacy

BOTHELL, Wash. — Seattle Genetics and Takeda's cancer drug subsidiary have started a late-stage clinical trial for a lymphoma drug, the companies said Wednesday.

Seattle Genetics and Millennium announced the start of a phase-3 trial of Adcetris (brentuximab vedotin) in patients relapsed cutaneous T-cell lymphoma that expresses the CD30 cell membrane protein. The study will enroll more than 120 patients who will be divided into two groups, one of which will receive Adcetris and another that will receive methotrexate or bexarotene.

ELMSFORD, N.Y. — BioScrip experienced a boost in revenue and gross profit during first quarter 2012 ended March 31.

HOLZKIRCHEN, Germany — The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.

NEW YORK — The Food and Drug Administration may be close to approving a drug for preventing HIV infection, according to published reports.

The Associated Press reported that the FDA had said Truvada (emtricitabine and tenofovir disoproxil fumarate), made by Gilead Sciences, appeared to be safe and effective for preventing HIV infection when taken daily. An FDA advisory committee will review the drug and decide whether to recommend its approval for pre-exposure prophylaxis, or PrEP.

DEERFIELD, Ill. — Walgreens on Monday announced it has completed its acquisition of certain assets of BioScrip’s community specialty pharmacies and centralized specialty and mail-service pharmacy businesses. The transaction represents a total deal value of approximately $225 million.

WHAT IT MEANS AND WHY IT'S IMPORTANT — A 30% rise in attendance at the Armada Specialty Pharmacy Summit is nothing to brush off — it's as clear an indication as any that specialty pharmacy is growing and probably poised for more growth in the near future, thanks in particular to the aging population and consequential rise in the number of people living with difficult-to-treat medical conditions.

SILVER SPRING, Md. — The number of new drug shortages has been halved as early notifications from manufacturers of potential shortages have increased sixfold, the commissioner of the Food and Drug Administration wrote Thursday.

DEERFIELD, Ill. — Walgreens Specialty Pharmacy on Thursday added six medications to its oral oncology cycle management program, in a significant expansion of the comprehensive treatment and support program it provides to benefit patients, physicians and payers, the company announced.