While Moderna Inc. CEO Stéphane Bancel was the one on the hot seat at a March 22 hearing before the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, biopharma profitability in general, and capitalism itself, came under fire as committee Chair Bernie Sanders (I-Vt.) railed about corporate greed in the sector.
For COVID-19, the limited durability of vaccines requires multiple injections, and their effectiveness is continuously challenged by emerging new spike variants of the virus. The SARS-CoV-2 main protease Mpro plays a role in major polyprotein processing events and is essential for viral replication.
Citing clinical trial data backed by real-world data, members of the U.S. FDA’s Antimicrobial Drugs Advisory Committee voted overwhelmingly, 16-1, March 16 that the overall benefit-risk assessment is favorable for the use of Pfizer Inc.’s Paxlovid to treat mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
Pfizer Inc.’s Paxlovid has become such a part of the COVID-19 treatment scene in the U.S. that it’s easy to forget it’s only authorized for emergency use. That could soon change. The FDA is convening its Antimicrobial Drugs Advisory Committee March 16 to consider Pfizer’s NDA for the co-packaged nirmatrelvir and ritonavir treatment.
Pardes Biosciences Inc. has patented 3C-like proteinase (3CLpro; Mpro; nsp5) (SARS-CoV-2; COVID-19 virus) inhibitors reported to be useful for the treatment of viral infections.
Exevir Bio BV has announced research detailing a novel, highly potent, anti-S2 camelid single-domain antibody, discovered at the VIB-Ugent Center for Medical Biotechnology, and developed as a candidate drug molecule by Exevir as XVR-013.
Researchers from Case Western Reserve University presented data from a study that aimed to investigate gut integrity, oxidized lipids and inflammatory markers associated with the pathogenesis of post-acute sequelae of COVID-19 (PASC).
The FDA’s emergency use authorization (EUA) program for rapid antigen tests for the COVID-19 pandemic is coming to an end, but few rapid antigen test makers have laid out clear plans regarding the post-public health emergency world. Quidelortho Corp. managed to beat the competition to the non-EUA market for these tests with a grant of de novo petition for its Sofia rapid antigen test, which now provides other tests with a predicate device, thus ensuring that this will not be the last such test to reach the U.S. market.
Immorna Biotechnology Co. Ltd. raised nearly $100 million in series A+ and A++ financing rounds to speed up the clinical development and commercialization of its RNA-based therapeutics. Founded in 2019, Immorna develops therapeutics and vaccines based on its RNA platforms, including conventional, self-replicating and circular RNA.
