Even as many in the U.S. are looking for the end of the COVID-19 public health emergency, Health and Human Services (HHS) Secretary Xavier Becerra reinforced expectations April 5 that he will continue the emergency declaration into the summer, if not beyond. When asked during a Senate Finance Committee budget hearing if he saw the emergency ending this summer, Becerra declined to give a date, but reiterated his commitment to give stakeholders at least 60 days’ notice.
Preclinical data on two newly designed mRNA molecules from Sunshine Biopharma Inc., of Montreal, showed they are effective at killing cancer cells grown in culture. Tests were performed on a variety of cancer cells, including multidrug-resistant breast cancer cells, ovarian adenocarcinoma cells and pancreatic cancer cells, while toxicology studies using normal human cells showed that the mRNA molecules had little or no cytotoxic effects.
After COVID-19 reached a pandemic peak in January due to the omicron variant, infections in the U.S. are now hitting the lowest levels since March of 2020. During the past week, there were 195,963 confirmed SARS-CoV-2 infections in the country, according to Johns Hopkins University data. That is 5.5% fewer infections than the same week two years ago and 56% fewer than last year. Deaths are also down to 5,602 for the week, although there were lower points in the spring and summer months of 2020 and 2021.
A phase II/III trial testing Inflarx NV's vilobelimab, a monoclonal antibody the company is developing to control inflammatory response, showed a relative reduction in 28-day all-cause mortality of 23.9% vs. placebo (p=0.094) for mechanically ventilated COVID-19 patients, but missed statistical significance on the measure, the study's primary endpoint.
Adagio Therapeutics Inc. plans to file for emergency use authorization in the second quarter of 2022 for its lead candidate, a monoclonal antibody (MAb) for preventing and treating COVID-19. With plenty of competing vaccines around, the company now thinks it has found the right group to receive it: the immunocompromised.
Results from the phase IIb challenge study with its intranasal immunomodulator for influenza A, REVTx-99a, in healthy volunteers sent Revelation Biosciences Inc. shares (NASDAQ:REVB) into a tailspin, and the stock closed at $1.32, down 82 cents, or 38.3%.
The Drugs Controller General of India has granted Novavax Inc. and the Serum Institute of India Pvt. Ltd. emergency use authorization (EUA) for Novavax’s protein-based COVID-19 vaccine. It was authorized for use in adolescents aged 12 to 18 years. The vaccine will be manufactured and marketed in India by the Serum Institute under the brand name Covovax.
Top-line interim phase I/II data from Icosavax Inc.’s virus-like particle COVID-19 vaccine fell short of company and market expectations. IVX-411, which displays the SARS-CoV-2 receptor binding domain, was found to be immunogenic and well-tolerated, but the level of immune response was lower than anticipated and inconsistent with data on Icosavax’s platform and its preclinical results.
