New research has pinpointed gene signatures that determine what immune responses will be activated in the development of sepsis, pointing to novel targets and opening the way for the stratification of clinical trials and for patients to be treated on the basis of their immune response, rather than their symptoms.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Belite, Revive.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Almirall, Astrazeneca, Bioarctic, Eisai, Entos, GC, GSK, Moderna, Novel, Roche, Santhera, Shattuck.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, 4Moving, Actinium, Arcturus, Eli Lilly, Genentech, Longboard, Moderna, Oculis, Pacylex, Prokidney, Sellas, Skye, Surrozen, Tharimmune, Vertex.
Moderna Inc. is gearing up to meet with regulators on the next steps for mRNA-1083, the first combination vaccine for influenza and COVID-19 to succeed in phase III testing, not only demonstrating noninferiority to individually licensed competitor vaccines but also eliciting statistically significant higher immune responses.
Although consensus was not reached on the World Health Organization’s pandemic agreement, the World Health Assembly recognized the progress made by member states to develop a pandemic agreement and to strengthen International Health Regulations (IHR, 2005) during the 77th World Health Assembly meeting held May 27 to June 1 in Geneva.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astellas, Biogen, Bristol Myers Squibb, Calliditas, Catalyst, Larimar, Invivyd, Minoryx, Pharming, Regeneron, Sanofi, Sifi, SN.
The U.S. Trade Representative (USTR) once again called out the usual cast of characters in this year’s Special 301 Report for not playing by the rules when it comes to protecting intellectual property. And once again, industry asked the USTR to go further by placing new players on the list.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Achieve, Astrazeneca, Bayer, BMS, Hutchmed, Inventiva, Marinus, Recce.
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