United States

FDA expedites drug/biologic development and approval

Thursday, October 15, 2015

The FDA has created four mecha­nisms to expedite development and approval of drugs and biologics that effectively treat serious diseases: Accelerated Approval, Breakthrough Therapy Designation, Priority Review and Fast Track Designation. Under­standing the requirements and ben­efits of each can inform decisions for your development program.

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GTx to initiate SUI trial

Wednesday, October 14, 2015

GTx, a Memphis-based biopharmaceutical company, has announced that the FDA has accepted the company’s investigational new drug (IND) application for a phase II clinical trial to treat postmenopausal women with stress urinary incontinence (SUI). The IND enables GTx to initiate a phase II proof-of-concept trial of enobosarm that will be the first clinical trial to evaluate a selective androgen receptor modulator (SARM) for SUI. The company plans to initiate the trial by the first quarter of 2016 and anticipates top-line data later in 2016.

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Baxter, Harvard launch Opsonix

Friday, October 9, 2015

Cambridge, Mass.-based Opsonix has launched with an $8 million Series A financing to develop a pathogen-extracting therapy designed to remove infectious pathogens and toxins from circulating blood.

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International diabetes research knowledge portal opens

Thursday, October 8, 2015

Researchers funded by the NIH and the Foundation for the NIH (FNIH) have expanded a recently launched online library, called a knowledge portal, which allows open-access searching of human genetic and clinical information on type 2 diabetes. Individual data will remain confidential. The portal includes information from several major international networks, collected from decades of research.

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Cancer Genetics gets approval to buy Response Genetics

Thursday, October 8, 2015

Cancer Genetics, a DNA-based cancer diagnostics provider, has received approval from the U.S. bankruptcy court in Delaware to purchase substantially all of the assets of Los Angeles-based Response Genetics Inc. (RGI), a CLIA-certified clinical laboratory focused on the development and sale of molecular diagnostic testing services for cancer. CGI also agreed to assume some of RGI’s liabilities. The sale is subject to certain customary closing conditions and is expected to close by Oct. 9.

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