Clinical Intelligence

FDA approves emergency treatment for chemotherapy overdoses

Monday, December 14, 2015

The FDA has approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving those cancer treatments.

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Treeway sees positive data results for ALS treatment

Thursday, December 10, 2015

Treeway, a biotech company developing therapies against amyotrophic lateral sclerosis (ALS), today announced the completion of two successful phase I trials with its lead compound TW001, a more patient-friendly oral formulation of the Japanese stroke and ALS therapy edaravone. [Read More]

Zafgen’s Beloranib IND gets complete clinical hold after second death

Monday, December 7, 2015

Zafgen, a Boston-based biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, has received verbal notice from the FDA that its beloranib investigational new drug (IND) application has been placed on complete clinical hold, affecting the ongoing open label extension (OLE) portion of the pivotal phase III ZAF-311 bestPWS clinical trial in patients with Prader-Willi syndrome (PWS). A complete clinical hold is an order that the FDA issues to a sponsor to suspend all clinical work requested under the company’s IND application.

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FDA approves anthrax vaccine

Monday, November 30, 2015

The FDA has approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.

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