The COVID-19 pandemic encouraged a lot of things, including shoddy product quality, but a recent FDA warning letter suggests that the associated need for tests also encouraged a few operations that had less than a full commitment to quality management.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bavarian Nordic, Biocytogen, Biogen, Curis, Daiichi, Jaguar, Moderna, Novavax, Okyo, Outlook, Sanofi, Sobi, Stemcyte, Takeda, Y-mabs.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, Aristea, Clover, Connect, Cybin, Forge, Hemostemix, Janssen, Jounce, Journey, Poxel, Sangamo, Vascular.
Right on cue, the U.S. FDA authorized bivalent COVID-19 vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE to be given as boosters at least two months following a primary vaccine series or a previous booster. “These updated boosters present us with an opportunity to get ahead of the next wave of COVID-19,” FDA Commissioner Robert Califf said, following the Aug. 31 announcement.
Hansoh Healthtech Co. Ltd., part of Jiangsu Hansoh Pharmaceutical Group Co. Ltd., has acquired exclusive worldwide rights to develop and commercialize an oral SARS-CoV-2 3C-like protease inhibitor from Beijing Huayi Health Drug Discovery Institute, also known as the Global Health Drug Discovery Institute (GHDDI). The deal includes ¥12 million (US$1.8 million) up front and up to ¥1.68 billion in potential milestone payments, plus tiered royalties on net sales.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bluebird, Innovent, Moderna, Pfizer, Pharmazz, Plus, Polpharma, Tracon.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aivita, Alnylam, Beyondspring, Fusion, Kinarus, Redcloud, Sirnaomics, Reneo, Valneva.
Immunoprecise Antibodies Ltd.'s Polytope TATX-03 antibody combination therapy has been shown to neutralize SARS-CoV-2 variants of concern, including the omicron BA.5 subvariant, in an authentic virus assay.
Stemcyte Inc. has received IND approval from the FDA for a phase II trial using umbilical cord blood stem cell therapy for post-COVID syndrome, or long COVID.
RSS
