Phase III
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.
Lundbeck revealed that its migraine drug Vyepti failed to demonstrate statistical superiority over placebo at reducing the number of monthly migraine days.
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.
Jazz Pharma is breaking new ground with its cannabidiol epilepsy treatment Epidiolex, taking the drug into a Phase III study in children and adolescents.
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.
Blueprint Medicines’ Ayvakit is headed to the FDA for a new indication after the drug hit the mark in Part 2 of the PIONEER trial for non-advanced systemic mastocytosis.
All other ongoing and pending studies of Sanofi’s amcenestrant, including the early-stage breast cancer trial AMEERA-6, will also be discontinued.
Weeks after AstraZeneca and Daiichi Sankyo were able to move the bar in the treatment of metastatic breast cancer with Enhertu, Gilead is answering that challenge with Trodelvy.
Clene Nanomedicine’s CNM-Au8 demonstrated surprising improvements in some MS patients, despite the study being halted early due to COVID-19.
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