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Regulators around the world are joining forces as part of an investigation into why a patient died after being treated in a Phase 1 clinical study conducted by Biotrial, a French clinical research organization. Read More
Citing a “detrimental effect on survival,” the FDA has placed a full clinical hold on the IND for CTI BioPharma’s myelofibrosis candidate pacritinib. Read More
Cambridge, Mass.-based Akashi Therapeutics has suspended a mid-stage clinical study of its HT-100 compound for the treatment of Duchenne muscular dystrophy, after one of its patients experienced “life-threatening health issues.” Read More
The FDA’s Psychopharmacologic Drugs Advisory Committee voted 8 to 2 to support a new claim for Takeda’s Brintellix for the treatment of cognitive dysfunction in major depressive disorder. Read More
An obesity candidate linked to patient deaths during a clinical trial last year may have a potential path forward after its sponsor revealed that it met its co-primary endpoints in a Phase 3 study. Read More
The Senate HELP Committee on Tuesday unanimously approved seven bills as part of its biomedical innovation agenda, the upper chamber’s piecemeal version of the House’s 21st Century Cures Bill passed in July 2015. Read More
Several major drugmakers are exploring development of a vaccine to prevent the Zika virus as the mosquito-borne disease spreads quickly throughout the Western Hemisphere. Read More