Content about Pharmacyclics

February 13, 2014

Janssen Biotech announced that the Food and Drug Administration has approved Imbruvica (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy.

HORSHAM, Pa. — Janssen Biotech on Wednesday announced the Food and Drug Administration has approved Imbruvica (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy. Imbruvica was first approved in November 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Both indications are based on an overall response rate. An improvement in survival or disease-related symptoms has not been established.

November 14, 2013

Drug makers Johnson & Johnson and Pharmacyclics have added Avella Specialty Pharmacy to their limited-distribution network for a newly approved blood cancer drug.

PHOENIX — Drug makers Johnson & Johnson and Pharmacyclics have added Avella Specialty Pharmacy to their limited-distribution network for a newly approved blood cancer drug.

Avella said Thursday that it had joined the limited-distribution network for Imbruvica (ibrutinib), which the Food and Drug Administration approved this week for mantle cell lymphoma. Avella is one of five specialty pharmacies to join the network, the company said.

November 14, 2013

Diplomat has joined the limited distribution network for a rare form of blood cancer drug marketed by Johnson & Johnson and Pharmacyclics.

FLINT, Mich. — Diplomat has joined the limited distribution network for a rare form of blood cancer drug marketed by Johnson & Johnson and Pharmacyclics.

The specialty pharmacy said Thursday that J&J subsidiary Janssen Biotech and Pharmacyclics had added it to the limited distribution network for Imbruvica (ibrutinib), which the Food and Drug Administration approved this week for mantle cell lymphoma.

November 13, 2013

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.

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.

February 13, 2013

The Food and Drug Administration has given a special, new designation to a cancer drug under development by Johnson & Johnson and Pharmacyclics, the companies said.

RARITAN, N.J. — The Food and Drug Administration has given a special designation to a cancer drug under development by Johnson & Johnson and Pharmacyclics, the companies said.

J&J subsidiary Janssen Research & Development and Pharmacyclics announced that the FDA had given breakthrough therapy designations to the experimental drug ibrutinib as a standalone therapy for relapsed or refractory mantle cell lymphoma in patients who have received prior therapy and for Waldenstrom's macroglobulinemia.