FDA expanded the approved use of Imbruvica (ibrutinib) for previously treated patients with Waldenström's macroglobulinemia. The drug received a breakthrough therapy designation for this use.
Amgen and its subsidiary Onyx Pharmaceuticals Inc. announced the submission of a supplemental New Drug Application to FDA and a Marketing Authorization Application to the European Medicines Agency for Kyprolis (carfilzomib) for Injection in relapsed multiple myeloma.
Array BioPharma Inc. reached an agreement with Novartis Pharma AG to acquire worldwide rights to encorafenib (LGX818), a BRAF inhibitor currently in phase III development. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline PLC on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals.
Health Canada granted a Class 3 Device License approval for the xTAG CYP2D6 Kit v3 genotyping assay, developed by Luminex Corporation.
SCOTT STRONG was named as chief of the Division of Gastrointestinal and Oncologic Surgery at Northwestern Memorial Hospital and surgical director of the Digestive Health Center.
FDA granted orphan drug designation to tarextumab (anti-Notch 2/3, OMP-59R5) for the treatment of both pancreatic cancer and small cell lung cancer.
The Society for Immunotherapy of Cancer, with support from Merck, is providing funding for cancer immunotherapy research through the SITC-Merck Cancer Immunotherapy Clinical Fellowship
President Barack Obama and several members of Congress announced a slew of initiatives this week aimed at eliminating the effects of sequestration for the government, and for medical research by providing increases for NIH and other federal agencies.
Robert Califf was named FDA Deputy Commissioner for Medical Products and Tobacco, a de facto No. 2 post at the agency.
The trial stemming from Duke University's clinical trials of a fraudulent genomic technology has been delayed, most likely until September.
