Be it viral, nucleic acid or protein vaccines, recent efforts that led to the first regulatory approvals for not only COVID-19, but also for malaria and respiratory syncytial virus, positioned infectious diseases in the headlines for much of the last four years. But despite that attention, or the threat of future pandemics, or the numerous infectious diseases for which there are no preventable vaccines and very little development activity, the level of private and public funding for biopharma companies working in the space is dismal – at least compared with that of oncology products, according to a new analysis report released by the Biotechnology Innovation Organization (BIO) on Jan. 25.
Researchers at ETH Zurich have identified a proteomic signature that could recognize long COVID six months after acute infection. Biologically, the signature indicated that the complement system remained active in patients with long COVID six months after infection. Translationally, it could lead to a diagnostic test for long COVID, and suggests that targeting the complement system could be a therapeutic approach to prevent or treat the disorder.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Applied, Asklepios, Boston, Curevac, Deciphera, Delta-Fly, Kiromic, Merck, Newron, Orion, Rivus, Verrica.
An FDA culture that discourages scientific disagreement with U.S. administration policies may be a perennial problem regardless of the party in power. That’s one of the between-the-lines takeaways from a Jan. 3 letter the Republican leadership of the House Energy and Commerce Committee sent to FDA Commissioner Robert Califf – along with a stern warning that the agency had better respond in a timely manner.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Therapeutics, Arch, Bridgebio, Inovio, Intensity, Invivyd, Melt, Obi.
Six months out from the World Health Organization ending the global health emergency brought on by the pandemic, there’s no need for the World Trade Organization to expand a five-year intellectual property (IP) waiver for vaccines to COVID-19-related drugs, devices and diagnostics.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adimab, AFT, Alpine Immune, Astellas, Genovior, Hyloris, Immunoscape, Juniper, Linkedup, Mithra, Polaris, Propella, Rafa, Shionogi, Tianti.
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.
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