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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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Incyte and Agenus Partner for Development of Immuno-Oncology Products

Incyte and Agenus will partner on immuno-oncology targets in a deal worth up to $410 million. The companies announced today that they have entered into a global license, development and commercialization agreement focused on novel immuno-therapeutics using Agenus’ proprietary Retrocycle Display antibody discovery platform. According to terms of the deal, …

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ASCO Submits Comments to Congress on FDA’s Proposed Regulation of Laboratory-Developed Tests

ASCO submitted comments Jan. 5 to the House Committee on Energy and Commerce, Health Subcommittee, strongly supporting the Food and Drug Administration’s proposed risk-based approach to regulation of laboratory developed tests (LDTs). LDTs are increasingly being used to guide therapy selection for patients with cancer. Failure of such tests to …

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