Novo Nordisk’s Wegovy pill approved in US as first oral GLP-1 for weight management
Wegovy pill showed a mean weight loss of 16.6% in the OASIS 4 trial
Wegovy pill showed a mean weight loss of 16.6% in the OASIS 4 trial
The therapy also drove additional weight loss at the higher 1.8 mg dose without plateauing and maintained a favorable tolerability profile
The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation
Under the agreement, AVT06 is licensed to enter the US market in the fourth quarter of 2026
Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
The study found BIC/LEN to be statistically non-inferior to BIKTARVY, Gilead’s current standard-of-care therapy
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival
The update promises to revolutionize laboratory workflows by optimizing resources
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