Tags : BLA

BMS and bluebird bio Report the US FDA’s Acceptance of

Shots: The US FDA has accepted the PR of BLA for idecabtagene vicleucel to treat adult patients with MM prior treated with at least three therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 Ab. The anticipated PDUFA date is Mar 27, 2021 The BLA is based on a P-II KarMMa study assessing […]Read More

UCB Reports the FDA’s and EMA’s Acceptance of BLA and

Shots: The marketing application submissions are based on three P-III studies- BE VIVID, BE READY, BE SURE assessing the safety and efficacy of bimekizumab in adult patients with mod. to sev. chronic PsO All 3 P-III studies met their 1EPs, demonstrating that bimekizumab achieved superior skin clearance @16wks. vs PBO and Humira (adalimumab) as measured […]Read More

LEO Reports the US FDA’s Acceptance of BLA for Tralokinumab

Shots: The BLA submission is based on P-III ECZTRA 1 & 2 studies assessing tralokinumab (300mg, SC) as monothx. vs PBO in 804 & 794 adults with mod. to sev. AD who were candidates for systemic therapy for 52wks. respectively The submission also follows the P-III ECZTRA 3 study assesses the safety and efficacy of […]Read More

Biogen and Eisai Complete the Submission of BLA to the

Shots: The completed submission followed ongoing collaboration with the FDA and includes clinical data from the P-III EMERGE and ENGAGE studies along with the P-Ib PRIME study. Additionally, Biogen has requested Priority Review The P-III EMERGE study met its 1EPs in patients treated with a high dose showed a reduction of clinical decline from baseline […]Read More

Mallinckrodt Reports Completion of BLA Submission to the US FDA

Shots: In Apr 2020, Mallinckrodt’s Stratatech initiated StrataGraft’s BLA submission process which is a regenerative skin tissue therapy to develop therapies for deep partial-thickness thermal burns in adults The BLA submission is based on P-III STRATA2016 clinical trial published in Journal of Burn Care & Research and is supported by STRATA2011 clinical trial (Published in […]Read More

Y-mAbs Reports the US FDA’s Acceptance of Priority Review for

Shots: The US FDA has accepted the Danyelza’s BLA for PR to treat patients with relapsed/refractory high-risk neuroblastoma with its anticipated PDUFA date as Nov 30, 2020 The company divulges in its BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application If approved, Danyelza […]Read More

Fresenius Kabi Reports the US FDA’s Acceptance of BLA for

Shots: The BLA submission is based on analytical, PK/ PD, safety and immunogenicity data from two clinical studies that demonstrated equivalent PK/ PD profile to Neulasta, similar immunogenicity & comparable safety profile in healthy volunteers The BLA represents Fresenius Kabi’s first biosimilar candidate submitted to the FDA. Additionally, Fresenius Kabi also received EMA’s acceptance for […]Read More

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

Shots: The BLA is supported by PALM clinical study conducted in the Democratic Republic of Congo. In Aug’2019, the trial was stopped early when preliminary results demonstrated that REGN-EB showed superiority over ZMapp REGN-EB3 demonstrated superior efficacy as compared to ZMapp across multiple measures, including reduced mortality and fewer days until the Ebola virus was […]Read More

Y-mAbs Reports the Submission of Naxitamab’s BLA to the US

Shots: Y-mAbs has submitted the BLA the US FDA under the FDA’s Rolling Review process for naxitamab following the market closure on Mar 31, 2020 The BLA submission is based on two P-II studies, 201 and 12-230 assessing the safety & efficacy of the therapy, which the company expects to present at a venue later […]Read More