Specialty Pharmacy

WASHINGTON — The Senate on Thursday voted to pass the Food and Drug Administration Reauthorization Act of 2017, sending the bill to the desk of President Donald Trump following the House’s passage of the legislation in June. The bill contains the reauthorizations of the FDA’s Prescription Drug, Biosimilar, and Generic Drug User Fee Acts.

SILVER SPRING, Md. — Janssen Biotech and Pharmacyclics’ Imbruvica (ibrutinib) has a new indication. The Food and Drug Administration on Wednesday approved the drug to treat adults with chronic graft versus host disease after one or more treatments have failed.

This approval makes Imbruvica the first FDA-approved treatment for the illness, which afflicts patients who have received hematopoietic stem cell transplantation to treat blood or bone marrow cancers. The illness occurs when cells from the stem cell transplant attack healthy cells in a patient’s tissues.

VALLEY FORGE, Pa. — AmerisourceBergen on Thursday reported its third quarter results, posting a 4.9% increase in revenue, which hit $38.7 billion. The company’s gross profit declined 2.5% to $1.1 billion, which it attributed to a $121 million decrease in gains from antitrust litigation settlements and a decrease in the pharmaceutical distribution services segment.

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday approved a new indication for Vertex Pharmaceuticals’ Kalydeco (ivacaftor). The new indication is for use in more than 600 people with cystic fibrosis ages 2 years and older who have one of five residual function mutations.

DEERFIELD, Ill. — Walgreens Boots Alliance has had a busy week.

As a minority investor, the company on Wednesday announced that it had formed a new company with KKR, through which the two acquired institutional pharmacy company PharMerica. The all-cash transaction is valued at roughly $1.4 billion and will make PharMerica a private company.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new, targeted treatment for patients with relapsed/refractory acute myeloid leukemia. Idhifa (enasidenib), from Celgene, was approved for use with the RealTime IDH2 Assay, used to detect specific mutations in the IDH2 gene in patients with acute myeloid leukemia.

FLINT, Mich. — Diplomat Pharmacy was among the fastest-growing southeast Michigan companies identified this year by Crain’s Detroit Business. The magazine’s annual Fast 50 list ranks companies based on three-year revenue growth.

DENVER — The first methotrexate oral solution approved by the Food and Drug Administration, Xatmep, is now available, manufacturer Silvergate Pharmaceuticals announced Monday. The drug, approved by the FDA in April, is indicated to treat acute lymphoblastic leukemia and manage polyarticular juvenile idiopathic arthritis in pediatric patients.