With the clock ticking down on 2023, the U.S. FDA seems to be scurrying to push final guidances out the door before the new year. This week, the agency has finalized several guidances, ranging from the development of monoclonal antibodies to treat or prevent COVID-19 to the use of real-world data in drug development.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurinia, Cellvax, Chiesi, Iama, Impact, Ocelot, Pfizer, Uvax.
Invivyd Inc.’s VYD-222 produced positive initial top-line results in the ongoing pivotal phase III Canopy study for preventing symptomatic COVID-19. The results could reach a vulnerable population of patients who are immunocompromised and don’t get the same protection as other patients, the company’s CEO, Dave Hering, told BioWorld.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzamend, Ascendis, Astellas, Basilea, Erasca, Geneuro, GSK, Orchard, Revbio, Shuttle, Skye.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adaptimmune, Antengene, CG Oncology, Century, Zhejiang Jingxin, Mymd, Neurocrine, Novartis, Novavax, Optinose, Phathom, PTC, Ractigen, Systimmune.
The Nobel Prize-winning modification that prevents the innate immune system from recognizing injected mRNA as foreign and blocking transcription of the protein it encodes has been found on some occasions to cause ribosomal frameshifting.
In a global first, Japan's Ministry of Health, Labor and Welfare has approved CSL Ltd.’s and Arcturus Therapeutics Inc.’s self-amplifying messenger RNA (sa-mRNA) vaccine (ARCT-154) for COVID-19 in adults. The approval marks the first milestone for a November 2022 licensing deal under which CSL subsidiary CSL Seqirus in-licensed Arcturus’ late-stage sa-mRNA vaccine platform technology.
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