Phase III
The American Society of Clinical Oncology and the Association of Community Cancer Centers are combining their efforts to increase racial and ethnic diversity in clinical trials.
Several biopharma companies are opening the week with positive clinical trial news. Read on for updates from Cytokinetics, Concert Pharmaceuticals, Idorsia and Seagen.
Burlingame, CA-based Innoviva is buying all of Waltham, MA-based Entasis Therapeutics’ available shares at $2.20 per share. Currently, Innoviva owns about 60% of Entasis’ outstanding shares.
Biohaven Pharma’s NDA for its nasal spray zavegepant was accepted by the FDA, while Phase III results for its drug troriluzole to treat spinocerebellar ataxia were disappointing.
Lifting the clinical hold will allow Ocugen to continue to assess the vaccine in its ongoing study and potentially support its efforts to achieve EUA or full approval.
Regeneron Pharmaceuticals shared positive results from its Phase III trial of an evinacumab for children with homozygous familial hypercholesterolemia.
Based on topline data, Pfizer stated that three doses of the COVID-19 vaccine met all immunobridging criteria required for EUA. The FDA’s advisory committee will meet June 15 to discuss the matter.
Alnylam Pharmaceuticals shared 18-month results from its phase III Helios-A clinical study demonstrating that vutrisiran improves clinical cardiac symptoms in patients with hATTR.
Two experimental drugs from Seres Therapeutics and Vera Therapeutics celebrate clinical trial wins in hard-to-treat disease areas.
The compact and portable nasal spray means it can be used directly before an anxiety-provoking trigger or at the beginning of an episode.
PRESS RELEASES