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The FDA is providing additional information on trial designs for sponsors developing therapies to treat allergic and nonallergic rhinitis and anthrax exposure. Read More
Incyte has discontinued a Phase 3 trial of Jakafi with capecitabine as a second-line treatment for patients with metastatic pancreatic cancer after the combination failed to show sufficient efficacy. Read More
The European Medicines Agency is asking for feedback on a revised guideline for the treatment of Alzheimer’s disease and other types of dementia. Read More
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