Clinical Intelligence

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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J&J begins Ebola vaccine regimen in Sierra Leone

Monday, October 19, 2015

Johnson & Johnson (J&J) has begun a safety and immunogenicity clinical trial in Sierra Leone of a preventive Ebola vaccine regimen in development at its Janssen Pharmaceutical Companies. Trial recruitment is underway, and the first volunteers have received their initial vaccine dose. It is the first study conducted of Janssen’s Ebola prime-boost vaccine regimen in a West African country affected by the recent Ebola epidemic.

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