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It’s not just academia- and industry-funded trials that are lacking in transparency; a recent audit by the Office of Inspector General (OIG) has found that the National Institutes of Health (NIH) failed to ensure that the results of the trials it funded were posted on ClinicalTrials.gov in line with federal reporting requirements. Read More
A federal court judge in Delaware has ruled in favor of Exela Pharma Sciences on all counts in a patent dispute over Eton Pharmaceuticals’s abbreviated new drug application (ANDA) to produce a generic version of Exela’s product Elcys. Read More
Despite getting a renewed green light from the FDA, Homology Medicines is putting the brakes on its phase 2 trial of a gene therapy for phenylketonuria (PKU) and shifting resources to a potentially more profitable path. Read More
The FDA has accepted Glaxo Smith Kline’s New Drug Application for momelotinib, just months after the behemoth snapped up the investigational myelofibrosis drug and the company that developed it — Sierra Oncology. Read More
The FDA issued a warning letter to Verde Cosmetics of Northridge, Calif., for failing to conduct microbiological testing of its topical drugs and lacking adequate cleaning procedures. Read More
Blueprint Medicines has enough pivotal data in hand to seek a new indication for Ayvakit (avapritinib) as a treatment for nonadvanced systemic mastocytosis and plans to file a supplemental new drug application later this year. Read More
The FDA has approved Bluebird Bio’s Zynteglo (betibeglogene autotemcel) for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. Read More