Clinical Intelligence

FDA approves Imlygic

Thursday, November 5, 2015

Amgen has announced that the FDA has approved the Biologics License Application for Imlygic (talimogene laherparepvec), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. Imlygic has not been shown to improve overall survival or have an effect on visceral metastases. Imlygic is the first oncolytic viral therapy approved by the FDA based on therapeutic benefit demonstrated in a pivotal study.

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Amgen’s first-in-class oncolytic drug OK’d by FDA

Wednesday, October 28, 2015

The FDA has approved Amgen’s Biologics License Application for IMLYGIC (talimogene laherparepvec), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. [Read More]

Mast Therapeutics initiates phase II vepoloxamer study

Monday, October 26, 2015

San Diego-based Mast Therapeutics, a clinical-stage biopharmaceutical company leveraging its molecular adhesion and sealant technology (MAST) platform to develop novel therapies for sickle cell disease, heart failure, and stroke, has initiated its phase II study of vepoloxamer for the treatment of patients with chronic heart failure. [Read More]

Zafgen updates on beloranib program

Monday, October 26, 2015

Zafgen, a Boston-based biopharmaceutical company dedicated to improving the health and well-being of patients affected by obesity and complex metabolic disorders, has announced a clinical update for beloranib, the company’s lead MetAP2 inhibitor product candidate.

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Imprimis releases low-cost Daraprim alternative

Monday, October 26, 2015

Imprimis Pharmaceuticals, a specialty pharmaceutical company focused on the development and commercialization of proprietary compounded drug therapies, has made a customizable, compounded formulation of pyrimethamine and leucovorin available for physicians to consider prescribing for their patients as a low-cost alternative to Daraprim.

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FDA OKs first reversal agent for Pradaxa

Monday, October 19, 2015

The FDA has granted Accelerated Approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.

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