Tags : Acceptance

Regulatory

Regeneron Reports the US FDA’s Acceptance of Priority Review for

Shots: The US FDA has accepted for priority review a BLA for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals The BLA is based on P-III study assessing efficacy & safety of REGEN-COV to treat non-hospitalized patients already infected with SARS-CoV-2, and to prevent symptomatic infection in […]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

Agios Reports the US FDA’s Acceptance of NDA and Priority

Shots: The NDA & MAA submissions are based on ongoing 2 studies i.e., ACTIVATE & ACTIVATE-T evaluates safety, tolerability & efficacy of mitapivat vs PBO in patients with PKD Results: 40% of patients achieved a hemoglobin response, 33% reduction in transfusion burden @ 24wks. fixed dose period & safety profile was consistent with previously reported […]Read More