March 24 Quick Takes: A first for Twist, Biotia and a refusal-to-file letter for Novo; plus Novartis’ radioligand, Zealand, four Japan approvals and more

Twist Bioscience Corp. (NASDAQ:TWST) said it and partner Biotia Inc. received emergency use authorization from FDA for the first hybridization capture-based next-generation sequencing SARS-CoV-2 assay. The SARS-CoV-2 NGS Assay can sequence and surveil the evolution of virus mutations over time and geography and enables batch analysis of up to 96 samples at once.

Semaglutide setback
Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) said FDA has issued a refusal-to-file letter for its NDA seeking a label expansion for a once-weekly 2.0 mg dosage of semaglutide to treat Type II diabetes. The agency requested additional information relating to the GLP-1 analog’s proposed new manufacturing site. The company expects to resubmit the application in 2Q21...