Tags : Severe

Biosimilars

Biogen Signs a License and Commercialization Agreement with Bio-Thera for

Shots: Bio-Thera to receive $30M up front following the achievement of P-III satisfactory results and is eligible for commercial milestones along with royalties. The transaction is expected to close in Q2’21 Biogen to get exclusive regulatory, manufacturing, and commercial rights of BAT1806 in all countries excluding China (includes Hong Kong, Macau, and Taiwan) Biogen will […]Read More

Regulatory

Regeneron and Sanofi Report the US FDA’s Acceptance of sBLA

Shots: The sBLA is based on P-III study assessing Dupixent + SOC maintenance therapy in children aged 6-11yrs. with moderate-to-severe asthma with type 2 inflammation The study resulted in a reduction of severe asthma attacks and rapidly improved lung function within 2wks, safety results were generally consistent with the known safety profile of Dupixent. Dupixent […]Read More