ANGLE plc has signed an agreement with Abbott in which Abbott will supply ANGLE with its proprietary PathVysion HER-2 DNA FISH Probe kits for ANGLE's ANG-002 FDA study for FISH (fluorescence in situ hybridization) analysis of circulating tumor cells in the form of a research grant.
FDA has approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc.) a radiolabeled somatostatin analog, for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors in adults.
Amgen said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending a label variation for Kyprolis (carfilzomib) to include updated overall survival data from the phase III head-to-head ENDEAVOR trial in patients with relapsed or refractory multiple myeloma (Kyprolis and dexamethasone versus Velcade [bortezomib] and dexamethasone).
Syndax Pharmaceuticals, Inc., a clinical stage biopharmaceutical company, announced a new clinical collaboration with AstraZeneca to evaluate the safety and efficacy of AstraZeneca's durvalumab, a human monoclonal antibody directed against programmed death-ligand 1, in combination with SNDX-6352, Syndax's monoclonal antibody inhibitor of Colony-StimulatingFactor 1 Receptor, across a variety of solid tumors.
Foundation Medicine Inc. said the company has entered into a broad partnership with Pfizer Inc.
FDA has approved the supplemental New Drug Application to add overall survival data from the phase III head-to-head ENDEAVOR trial to the Prescribing Information for Kyprolis (carfilzomib).
Novartis said its supplemental Biologics License Application for Kymriah (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for or relapse after autologous stem cell transplant (ASCT) has been accepted by FDA for Priority Review.
FDA expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of metastatic breast cancer whose tumors have a specific germline mutation.
FDA has approved Genentech's Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence.
FDA approved Cabometyx (cabozantinib) tablets for the expanded indication of patients with advanced renal cell carcinoma.
