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
Shots: SciClone has submitted the BLA for Danyelza to treat pediatric patients aged >1 yr. and adult patients with r/r high-risk neuroblastoma to NMPA in China If approved, the therapy will be available in the China imminently. The therapy was approved under accelerated approval based on ORR and DoR while the continued approval for the […]Read More
Shots: The BLA submission is based on results from the P-III Archway study involves assessing PDS with ranibizumab, refilled @6mos. at fixed intervals, vs ranibizumab (0.5mg, monthly IVT) in 418 patients with nAMD, prior treated with VEGF therapy Results: 98.4% of PDS patients were able to go 6mos. without needing additional treatment & achieved vision […]Read More
Shots: The US FDA has accepted for review the BLA for bevacizumab, pursuant to section 351(k) pathway of the Public Health Service Act, and with anticipated BsUFA date in the Q2’22 Amneal and mAbxience reported that data supports the bio similarity of its Alymsys to the reference, Avastin. The company expects its initial biosimilar portfolio […]Read More
Shots: The BLA submission is based on P-III UNITY-CLL trial evaluating ublituximab + Ukoniq (U2) vs obinutuzumab + chlorambucil in a ratio (1:1) in 420 patients with treatment-naive and r/r CLL. The 1EP of the study was PFS The trial is being conducted under a SPA agreement with the US FDA. The FDA also notified […]Read More
Shots: The submission is based on PATHFINDER clinical program including P-III NAVIGATOR that involves assessing Tezepelumab + SOC vs PBO + SOC in 1061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe and uncontrolled asthma The study demonstrated 56% reduction in AAER @52wks. in the overall population. The study also met 1EPs in the subgroup of […]Read More
Shots: The companies confirm the planned timeline for resubmission of the BLA for FYB201 following a successful pre-BLA interaction with the US FDA In Nov’2020, the initial submission strategy of FYB201 (biosimilar referencing Lucentis) has been adjusted as part of a simplification of the approval procedure The BLA-submission is expected to be filed with the […]Read More
Shots: The US FDA has accepted the PR of BLA for TicoVac to prevent TBE in patients aged ≥1year with an anticipated PDUFA date in Aug 2021. If approved, the vaccine may help reduce the risk of TBE for people traveling to endemic areas The BLA is based on clinical trials that assess TicoVac across […]Read More
Shots: The US FDA has accepted the BLA under the 351(k) for CHS-1420 with an anticipated BsUFA date as Dec’2021 The company plans to launch the CHS-1420 in the US on or after Jul 01, 2023 as per the terms of an agreement with AbbVie Coherus collaborated with Junshi in Feb’2021 to in-license toripalimab in […]Read More
Shots: The BLA submission is based on data from P-III clinical comparison study that demonstrated BAT1706 is highly similar to reference bevacizumab in clinical efficacy, safety, and immunogenicity. The anticipated BsUFA date is Nov 27, 2021 The BLA seeks approval of BAT1706 for mCC in combination with fluorouracil-based CT, 1L treatment for nsq. NSCLC, recurrent […]Read More
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