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The FDA has dinged a clinical investigator in a warning letter for failing to conduct an investigation, according to the investigational plan. Read More
Drugmakers submitting anonymous clinical data in applications to the European Medicines Agency must keep up on technology advances that could put that data at risk for re-identification. Read More
With only 2 percent to 7 percent of adult cancer patients participating in clinical trials, social media may provide a boost to enrollment with targeted messages to connect patients, caregivers and families with potential trial enrollment websites, according to a study in JAMA Oncology. Read More
An FDA advisory committee gave Celltrion’s biosimilar candidate for Remicade a strong show of support in February, backing its approval for six different indications. Read More
The European Medicines Agency has launched its PRIority MEdicines initiative to accelerate breakthrough therapies that offer a major therapeutic advantage over existing treatments. 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
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