Tags : BLA

Clinical Trials

Agenus Reports the Withdrawal of BLA for Balstilimab to Treat

Shots: The company has reported the voluntary withdraw of balstilimab’s BLA in patients with cervical cancer, following the US FDA’s recommendation & the decision follows the full approval of pembrolizumab The company will discontinue its ongoing BRAVA trial evaluating Balstilimab & plans to launch expanded access programs to provide patient access to balstilimab in multiple […]Read More

Biosimilars

Formycon and Bioeq Report the US FDA’s Acceptance of BLA

Shots: The US FDA has accepted the BLA for FYB201, a biosimilar referencing Lucentis for review and assigned a target action date for the application for Aug’2022 Following the approval, Coherus will commercialize FYB201 in the US whereas Formycon will participate economically in US sales through its interest in royalties paid by Coherus to Bioeq […]Read More

Regulatory

Eisai Initiates Rolling Submission of BLA to the US FDA

Shots: The submission is based on clinical, biomarker & safety data of Study 201 POC study evaluates lecanemab (10mg/kg, q2w) in 856 patients with MCI due to AD with confirmed presence of amyloid pathology. The BLA is being submitted under accelerated approval The results showed a reduction in brain amyloid by 0.306 SUVr units @18mos. […]Read More

Biosimilars

Formycon and Bioeq Report Submission of BLA to the US

Shots: Formycon and partner Bioeq have submitted a BLA for FYB201 (biosimilar referencing Lucentis) to the FDA Lucentis is a mAb fragment used to treat various types of macular-degenerative diseases and other serious eye diseases. If approved, Coherus will commercialize FYB201 in the US Currently, Formycon has four biosimilars while Coherus also has a biosimilar […]Read More

Regulatory

AstraZeneca and Amgen Report the US FDA’s Acceptance of BLA

Shots: The BLA is based on PATHFINDER clinical program, including P-III NAVIGATOR study evaluating Tezepelumab + SOC vs PBO + SOC in 1,061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe & uncontrolled asthma who receive treatment with medium/high dose ICS + at least 1 additional controller medication with/out OCS The results demonstrated superiority in 1EP […]Read More