Specialty Pharmacy

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Novartis that is designed to prevent tumors in the gastrointestinal tract from recurring after surgical removal, the agency said.

The FDA approved Novartis' Gleevec (imatinib) for adults who have had gastrointestinal stromal tumors, or GIST, removed. The drug was specifically approved for people whose tumors are known as CD117-positive, which includes 95% of all GIST tumors.

The drug was originally approved in 2001 for a type of leukemia.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Vertex Pharmaceuticals for treating a rare form of cystic fibrosis, the agency said Tuesday.

The FDA announced the approval of Kalydeco (ivacaftor) for treating patients ages 6 years and older with CF who have a mutation called G551D in the cystic fibrosis transmembrane regulator gene.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating the most common type of skin cancer, the agency said Monday.

The FDA announced the approval of Genentech's Erivedge (vismodegib) for adults with basal cell carcinoma who are not surgery or radiation therapy candidates and whose disease is locally advanced or has spread to other parts of the body.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

The FDA announced the approval of Inlyta (axitinib) for patients with advanced kidney cancer, also known as renal cell carcinoma, who have not responded to another drug for the disease. The drug, a twice-daily pill, works by blocking certain proteins called kinases that are involved with tumor growth and disease progression.

FLORHAM PARK, N.J. — Specialty pharmacy services company Armada Health Care and Definitive Homecare Solutions have signed a deal whereby Definitive Homecare's CPR+ specialty pharmacy software will integrate with Armada's service offerings, the two companies said.

The combination will give CPR+ customers access to Armada's value-added services and the ability to integrate those services within their pharmacy workflow system. Armada members that don't use CPR+ will have access to discount pricing for the software.

ALTAMONTE SPRINGS, Fla. — A specialty pharmacy chain has earned accreditation from the Accreditation Commission for Health Care.

BioPlus Specialty Pharmacy said ACHC accreditation indicates that the organizational management, internal processes, patient safety practices and service outcomes at BioPlus meet the highest standards.

THOUSAND OAKS, Calif. — Drug maker Amgen is acquiring a Rockville, Md.-based company developing therapies for cancer, the companies said Thursday.

Amgen announced plans to buy Micromet for $1.16 billion, or $11 per share. Micromet, originally founded in Germany, is developing blinatumomab, currently in phase-2 trials as a treatment for acute lymphoblastic leukemia and non-Hodgkin's lymphoma. The acquisition also will include the company's research and development center in Munich.

ALLENTOWN, Pa. — Medical device maker PMD Healthcare has launched what it calls the first personal spirometer to monitor lung function, the company said.

PMD, based in Allentown, Pa., announced the launch of the Spiro PD, which recently received approval from the Food and Drug Administration. The device is designed to enable patients with such lung diseases as asthma, chronic obstructive pulmonary disease, cystic fibrosis and lung transplants "easily and accurately" monitor lung function anytime and anywhere.