Without the COVID-19 pandemic, projected values of biopharma nonprofit collaborations and grants would be 72% and 30% below last year’s levels, although it is impossible to know what deals may have come to fruition in a world absent of the disruptive SARS-CoV-2 virus.
PERTH, Australia – Sydney-based Recce Pharmaceuticals Ltd. completed a placement of AU$27.95 million (US$19.69 million) to advance its synthetic anti-infective pipeline to address antibiotic-resistant superbugs and emerging viral pathogens.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adial, Alexion, Blueprint, Brickell, Cardiol, Daiichi, Eisai, Galapagos, Gilead, Kaken, Neurophth, Olix, Oncoheroes, Rakuten, Remegen, Spirovant, Vertex, Xiangxue.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcellera, Amarna, Clover, Dynavax, Endo, Fulcrum, Grand River Aseptic, GSK, IGM, Immunoprecise, J&J, Janone, Lambdavision, Litevax, Molecular Partners, Novavax, Par, Rockwell, Valo.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apeiron, Beyondspring, BMS, Genfit, Hansa, Marinus, Menarini, Novavax, Radius Rhizen, Uniqure.
LONDON – The U.K. will become the first country to stage a human challenge trial in which volunteers are deliberately infected with SARS-CoV-2, as a fast route to assessing the effectiveness of COVID-19 vaccines, and to build understanding of what an effective immune response looks like. The contract research organization Open Orphan plc said it is in advanced negotiations with the U.K. government and other partners for the studies, which are expected to be formally announced next week.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA stands by plasma EUA; Benzodiazepines to get added warnings; EMA posts draft guidance for registry-based studies; SEC finalizes whistleblower changes; Gilead to pay $97M; Plandai, CEO settle with SEC.
RSS
