FDA and the European Medicines Agency accepted regulatory applications for Gilotrif (afatinib), sponsored by Boehringer Ingelheim, for the treatment of advanced squamous cell carcinoma of the lung, after treatment with first-line chemotherapy.
BTG plc of London said that Wellstat Therapeutics' new drug application for uridine triacetate has been accepted for review by FDA.
Can-Fite BioPharma Ltd. of Petach Tikva, Israel, said FDA has granted the company's drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer. CF102 had already received the FDA's Orphan Drug designation.
AbbVie has submitted a supplemental New Drug Application to FDA based on the randomized, multi-center, open-label phase III RESONATE trial of IMBRUVICA (ibrutinib) versus chlorambucil in treatment-naive chronic lymphocytic leukemia patients aged 65 years or older.
FDA granted Priority Review for alectinib, an oral investigational anaplastic lymphoma kinase inhibitor, for the treatment of people with ALK-positive, locally advanced or metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib.
Today, 836 medicines and vaccines are in development for cancer by U.S. biopharmaceutical companies—all of which are either in clinical trials or awaiting review by the FDA—according to a report from the Pharmaceutical Research and Manufacturers of America.
The Ontario Institute for Cancer Research and the Structural Genomics Consortium in Toronto developed a new drug prototype, called OICR-9429, and made it freely available to the research community.
Vaccinogen Inc. entered into an agreement with Dublin City University, through one of its subsidiaries, to provide an exclusive two-year option to evaluate and acquire a high-throughput, multiplex, analysis platform, DiCAST.
Sequenom Inc. entered into a clinical research collaboration with the University of California, San Diego Moores Cancer Center to explore the utility of Sequenom's new liquid biopsy assay to comprehensively profile circulating cell-free tumor DNA in blood to enable serial monitoring and assist with therapy selection in cancer patients.
Janssen Biotech Inc. announced an exclusive, worldwide license agreement with Alligator Bioscience AB for ADC-1013, an immuno-oncology agent currently in phase I clinical studies.
