Phase II
BrainVectis will begin assessing a gene therapy for Huntington’s disease in France after receiving clearance from health authorities there to conduct a Phase I/II study.
A combination of Novo Nordisk’s CagriSema injection for overweight people with type II diabetes resulted in a 15.6% body weight reduction compared to taking the drugs individually.
Tessa Therapeutics has tapped former Takeda executive Thomas Willemsen as the man to take its CAR-T portfolio forward.
In a letter to shareholders, RegeneRx provided a pipeline update for investors Monday, outlining plans to potentially move forward with a new asset in light of development delays.
The FDA is busy accepting drug applications, granting specialty designations and approving drugs for market. Here’s a look at this week’s FDA activity.
Novartis’ canakinumab failed again in non-small cell lung cancer while Anixa Biosciences, Palisade Bio and Genexine kicked off new trials.
HHS found nearly half of NIH clinical trials were reported incorrectly, in violation of federal standards, according to a new report issued Friday by the agency.
The regulatory path for companies developing drugs for rare diseases is often fraught with challenges. KemPharm CEO Travis Mickle discussed just some of these with BioSpace.
Curis announced that the FDA has allowed patient enrollment to resume in the monotherapy phase of its TakeAim Leukemia Phase I/II trial studying emavusertib.
Ryvu and Opthea have new funding to work with, Tessa Therapeutics and Enlivex kick off new trials and Revive Therapeutics amends the Phase III protocol for its COVID-19 hopeful.
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