FDA approved Bendeka (bendamustine hydrochloride) injection, a 10-minute infusion formulation of bendamustine.
Amgen entered into a definitive agreement with GSK to reacquire all of its remaining rights to Prolia (denosumab), XGEVA (denosumab) and Vectibix (panitumumab) in 48 countries in Asia, South America, Europe, Australia and other regions.
Stem Cell Theranostics and CapellaBio established a cardio-oncology collaboration to discover novel drug therapies to prevent cardiotoxicity associated with various oncology drugs.
Amgen submitted a variation to its Kyprolis marketing authorization application to the European Union, to include a combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The application is based on results from the phase III head-to-head ENDEAVOR study in which patients with multiple... […]
The European Medicines Agency granted Orphan Drug Designation to Debio 1143 for treatment of ovarian cancer. Debio 1143 is an oral, small molecule inhibitor of apoptosis proteins with a dual pro-apoptotic and immunomodulatory mode of action developed as a potent chemo/radiosensitizer in oncology. Further to the encouraging signs of efficacy seen in clinical phase I... […]
FDA cleared for marketing the first cooling cap to reduce hair loss in female breast cancer patients undergoing chemotherapy. The Dignitana DigniCap Cooling System is indicated to reduce the frequency and severity of alopecia during chemotherapy in breast cancer patients in which alopecia-inducing chemotherapeutic agents and doses are used. It is a computer-controlled system that... […]
FDA approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these treatments. “Today’s approval is a first-of-its-kind therapy that can potentially save lives following overdose or life-threatening toxicity from these chemotherapy... […]
FDA granted accelerated approval to Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer, who have progressed on or are intolerant to crizotinib.
Eli Lilly and Company and Merck announced an immuno-oncology collaboration that will evaluate abemaciclib (LY2835219), Lilly’s cyclin-dependent kinase 4 and 6 inhibitor, and Merck’s Keytruda (pembrolizumab) in a phase I study across multiple tumor types. Based on the trial’s results, the collaboration has the potential to progress to phase II trials in patients who have... […]
AstraZeneca and Voluntis announced plans to test a digital support service for women undergoing treatment for recurrent platinum-sensitive high-grade ovarian cancer in clinical trials of cediranib plus olaparib. The service has been developed by Voluntis in clinical collaboration with AstraZeneca and NCI. It is delivered through a smartphone app paired with a web portal to... […]
