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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
In a rare warning letter to an institutional review board, CDER’s Office of Scientific Investigations contends that an IRB at Monmouth Medical Center was lax in supervising research at the facility. Read More
The FDA plans to establish a system that would allow for the use of “real-world evidence” to help the agency more quickly identify safety signals and address concerns, according to its list of strategic priorities for 2016-2017. Read More
Telesta Therapeutics has received a complete response letter from the FDA, informing the company that its BLA for Mycobacterium phlei cell wall-nucleic acid complex would need an additional Phase 3 clinical trial to adequately establish the candidate’s efficacy and safety. Read More
With 12 nations signing off on the Trans-Pacific Partnership on Wednesday, the clock has started on ratification of the treaty providing up to eight years of exclusivity for biologics. Read More