Tags : Review

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

Biotech

BMS and bluebird bio to Resubmit the BLA for Idecabtagene

Shots: Shots: The companies receive the US FDA’s Refusal to File letter regarding the BLA for idecabtagene vicleucel for patients with heavily pre-treated r/r MM, which was submitted in Mar’2020 Upon preliminary review, the US FDA determined that the Chemistry, Manufacturing and Control module of the BLA requires further detail to complete the review Ide-cel […]Read More

Insights+

PharmaShots Year in Review 2018

 PharmaShots Year in Review | Top 10 Pharma News of 2018  1. Celgene to Acquire Juno for its Cellular Immunotherapy & Hematology Portfolio Published: 22 Jan, 2018 | Tags: Celgene,  Acquire, Juno, Cellular, Immunotherapy, Hematology Portfolio 2.  Sanofi to Acquire Bioverativ for its Hemophilia Products Published: 22 Jan, 2018 | Tags: Sanofi, Acquire, Bioverativ, Treat, […]Read More