Tags : Treat

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

AbbVie Submits Regulatory Applications to the US FDA and EMA

Shots: The submission is based on two P-III studies KEEPsAKE-1 & -2 studies involves assessing Skyrizi (150mg) vs PBO in adult patients with active PsA who had an inadequate response or intolerant to biologic therapy and/or non-biologic DMARDs respectively The 1EP and 2EP of both studies showed ACR20 response @24wks., improvements in disease activity, skin […]Read More