Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerus, Ortho Clinical Diagnostics, Profound Medical.
The latest global regulatory news, changes and updates affecting biopharma, including: Pandemic not the time for trade restrictions; Longer-term vaccine follow-up crucial; Labeling update advised for chloroquines; FDA stands up new DDT path; FDA drafts DDI guidance; MHRA continues Brexit updates; FDA debars three.
Just ahead of the U.S. celebration of Thanksgiving, the FDA granted an accelerated approval for Danyelza (naxitamab), a new therapy for certain adults and children with relapsed or refractory high-risk neuroblastoma. The antibody, which Y-mabs Therapeutics Inc. initially sublicensed via a deal with Mabvax Therapeutics Inc. in 2018, is approved for use in combination with granulocyte macrophage colony-stimulating factor. The regulator had assigned the BLA a Nov. 30 PDUFA date.<
LONDON – Long-awaited guidance on the EU regulation for in vitro diagnostics (IVD) that comes into force in May 2022 arrived as the industry increased its calls for implementation to be postponed, citing the extent to which the COVID-19 pandemic has derailed work on bringing products into compliance with the new rules.
Kantaro Biosciences LLC, a joint venture between the Mount Sinai Health System and RenalytixAI, has received emergency use authorization from the U.S. FDA for its semi-quantitative SARS-CoV-2 IgG antibody test kit. Known as COVID-Seroklir, the test determines the presence and precise level of IgG antibodies. It has demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acarix, Applied DNA, Co-Diagnostics, Corticometrics, Kantaro, Rapidrona.
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