As COVID-19 vaccine development continues, the U.S. FDA is releasing a revised version of its 2020 guidance, “Development and licensure of vaccines to prevent COVID-19.”
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4SC, Ardelyx, Astrazeneca, Bio4t2, Brainstorm, Caribou, Celularity, Hyloris, Intellia, Mirum, Novavax, Orasis, Sage, Tiziana, UCB, Ymabs.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ayala, Basilea, Beam, Biosight, Eli Lilly, Geneuro, Gigagen, Gilead, Gravitas, Mablink, Microvascular, Oxford Nanopore, Pfizer, Qnovia, Seagen.
Researchers from Generate Biomedicines Inc. have detailed the discovery and preclinical characterization of GB-0669, a spike S2-targeted monoclonal antibody (MAb) being developed for the prophylaxis of SARS-CoV-2 infection. Machine learning models were used to identify MAbs targeting the conserved S2 stem helix and RBD class IV region of spike.
The official end of the COVID-19 public health emergency in the U.S. in May did not mark the end of interest and investment in the area. In the shifting landscape, attention has pivoted to new markets, emerging strains, boosters, and the commercialization and distribution of COVID-19 vaccines and therapies.
In a study published in Nature on Oct. 11, coinciding with the beginning of IDWeek 2023 in Boston, researchers from Harvard Medical School described EVEscape, a method for anticipating the movements of SARS‑CoV‑2 by predicting potential mutations likely to escape current vaccines and treatments.
The vagaries of the COVID-19 market and the uncertainties of pandemic fatigue are hitting some biopharma companies in the pocketbook, at least for now. Due to lower-than-expected revenues from its COVID-19 Comirnaty vaccine and antiviral Paxlovid (nirmatrelvir/ritonavir), Pfizer Inc. reduced its 2023 revenue guidance by $9 billion after hours Oct. 13, saying it now anticipates full-year 2023 revenues to range from $58 billion to $61 billion – down from its previous guidance range of $67 billion to $70 billion.
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