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Committee Recommends Continuation of CTI BioPharma’s Ovarian Cancer Study

Today, CTI Biopharma Corp. announced that an independent committee has recommended that the company continue its ovarian cancer study. The company said that the Gynecologic Oncology Group, now part of NRG Oncology, informed CTI that an independent Data Monitoring Committee (DMC) recommended continuation of the Phase III GOG-0212 clinical study, …

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Genentech’s Investigational Monoclonal Antibody Granted Breakthrough Status for Treatment of Lung Cancer

US-based Genentech recently announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its investigational cancer immunotherapy. The agency granted the designation to Genentech’s MPDL3280A for treatment of patients with Programmed Death-Ligand 1 (PD-L1) positive non-small cell lung cancer (NSCLC) whose disease has progressed during …

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Amgen Submits Applications for Approval of its Multiple Myeloma Drug Kyprolis in the US and Europe

Amgen and its subsidiary Onyx Pharmaceuticals, Inc. recently announced that it has submitted applications to both US and EU health regulators for approval of Kyprolis (carfilzomib) for treatment of multiple myeloma. The companies said that they have submitted a supplemental New Drug Application (sNDA) to the US Food and Drug …

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Insys’ Ovarian Cancer Treatment Receives Orphan Drug Designation from the FDA

The US Food and Drug Administration (FDA) granted Orphan Drug designation for Insys Therapeutics’ ovarian cancer candidate. The agency granted the designation to Insys’ Liposomal Encapsulated Paclitaxel (LEP) candidate for the treatment of ovarian cancer. The FDA’s Office of Orphan Products Development grants novel drugs or biologics that treat rare …

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Syncona and UCL Business Form Cancer Immunotherapy Company Autolus

Backed with roughly $45.5 million, Investment company Syncona and UCL Business, the wholly-owned technology transfer company of University College London, have launched the latest CAR T upstart, Autolus Limited. According to the companies, Autolus is a biopharmaceutical company focused on the development and commercialization of next-generation engineered T-cell therapies for …

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Study Finds Although Fewer Colorectal Patients Having Surgery, Survival Rates are Improving

While patients with metastatic colorectal cancer are undergoing less surgery for the removal of their primary tumors, survival rates for the disease are improving, according to a new study. According to The University of Texas MD Anderson Cancer Center, with new chemotherapeutic and biologic agents available for managing metastatic colorectal …

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