Amgen and Allergan plc. said they have submitted a Biologics License Application to FDA for ABP 980, a biosimilar candidate to Herceptin (trastuzumab).
Kite Pharma Inc. said it has submitted a Marketing Authorization Application to the European Medicines Agency for axicabtagene ciloleucel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma , transformed follicular lymphoma, and primary mediastinal B-cell lymphoma who are ineligible for autologous stem cell transplant.
Bristol-Myers Squibb Co. and IFM Therapeutics signed a definitive agreement under which BMS will acquire all of the outstanding capital stock of IFM Therapeutics, a venture-backed biotech company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory disorders.
Bristol-Myers Squibb Co. and Clovis Oncology Inc. formed a clinical collaboration to evaluate the combination of BMS's Opdivo and Clovis Oncology's poly (ADP-ribose) polymerase inhibitor Rubraca in pivotal phase III clinical trials in:
Loxo Oncology Inc. said the company has entered into an agreement to purchase the Bruton's tyrosine kinase inhibitor program from RedxPharma Plc. The lead candidate from this program is expected to enter clinical development in 2018. Under the terms of the agreement, Loxo Oncology has made a $40 million payment to Redx Pharma Plc for the full acquisition of the BTK discovery program, including lead candidate LOXO-305 (formerly RXC005). Loxo Oncology is not subject to milestone or royalty obligations.
Indivumed will partner with MedStar Health to help individualize anti-cancer medical therapies through biospecimen collection, preservation and analysis.
Ramon Parsons was named director of the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai effective July 1.
The American Society for Radiation Oncology selected 23 members to receive the ASTRO Fellow designation.
Emmanuel Quien has joined the Fox Chase cancer Center Department of Hematology/Oncology.
Patients for whom there are no existing treatments watch with desperation as a potentially helpful new drug spends years working its way from a lab bench, through clinical trials, and finally to the FDA, where reviewers consider it for approval.
