CTI BioPharma Corp. said it plans to submit a new drug application to FDA following a productive pre-NDA meeting for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R.
Roche NimbleGen introduced an enhanced whole exome sequencing solution for medical and translational research.
ICON, a provider of drug development solutions, said it's working with IBM to help reduce the time and costs of drug development while also offering patients enhanced quality of care by connecting them to relevant clinical trials. ICON said it will tap Watson's cognitive computing power to help the process of identifying patients who meet the criteria for a clinical trial, and to analyze protocols to assess trial feasibility and identify optimal trial sites.
AstraZeneca and Peregrine Pharmaceuticals Inc. entered into a cancer immunotherapy clinical trial collaboration.
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.
