Specialty Pharmacy

HOLZKIRCHEN, Switzerland — Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.

Sandoz (pronounced “SAN-doh”), the generics arm of Swiss drug maker Novartis, announced the start of a phase-2 trial of rituximab, a biosimilar of Genentech’s Rituxan, used to treat such conditions as non-Hodgkin’s lymphoma and rheumatoid arthritis.

OSAKA, Japan — Japanese drug maker Takeda Pharmaceutical  has signed an agreement with Durham, N.C.-based Zinfandel Pharmaceuticals to develop a test for assessing Alzheimer’s disease risk in adults, the two companies said.

CINCINNATI — Specialty pharmacy and home infusion provider CarePoint Partners has acquired a Houston-based infusion company that it said would make it a leader in the Texas market.

CarePoint announced the acquisition of ivA Lifetec, a home-infusion pharmacy that specializes in infusions for children, as well as nursing. Financial details were not disclosed. CarePoint said Lifetec was its 10th acquisition since December 2007, and that it now provides home infusion and specialty services in seven states.

NASHVILLE, Tenn. — The Food and Drug Administration has approved a new formulation of a drug for treating acetaminophen poisoning.

Cumberland Pharmaceuticals announced Thursday that the agency had approved a version of Acetadote (acetylcysteine) injection that does not contain preservatives or stabilization and chelating agents, and will replace the currently marketed version. The drug originally was approved in 2004.

ST. LOUIS — K-V Pharmaceutical announced Wednesday that the Food and Drug Administration extended its Prescription Drug User Fee Act action date to April 13 for a drug under development for preventing preterm birth.

K-V, which acquired the injected drug Gestiva (hydroxyprogesterone caproate) from Hologic in 2008, said Hologic originally had been told the FDA would take action Thursday.

K-V said it was confident the drug would receive approval and that the FDA would take action on or before the new PDUFA date.

BOSTON — Various companies in the healthcare industry are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategy program, and most think it needs a major overhaul, according to a study by the Tufts University Center for the Study of Drug Development.

The CSDD called the study the first systematic look at REMS since the FDA introduced the program in 2008. The FDA requires drug companies to create a REMS when the agency decides it is necessary to ensure that a drug’s benefits outweigh its risks.

LAKE MARY, Fla. — Specialty pharmacy provider Axium Healthcare Pharmacy has launched an online portal to complement its services, the company said Wednesday.

AxiumPortal.com allows patients to manage their accounts, request refills, make co-payments, set reminders and perform other functions.

CAMBRIDGE, Mass. — It appears that French drug maker Sanofi-Aventis’ efforts to acquire U.S. biotech company Genzyme are getting somewhere, according to company and media reports.