The National Institute of Allergy and Infectious Diseases (NIAID) is set to conduct a phase I trial with Tonix Pharmaceuticals Holding Corp.’s TNX-1800 (recombinant horsepox virus, live vaccine), a vaccine candidate to protect against COVID-19.
The U.S. FDA recently released a guidance for non-invasive remote monitoring devices, which were granted tremendous leniency during the COVID-19 pandemic as a means of reducing the demands on hospitals and doctor’s offices. That policy has been extended for the non-COVID era as part of the agency’s strategic plan to improve health equity by ensuring that access to digital health technologies is enjoyed by diverse American populations in a variety of health care access-challenged geographical areas.
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.”
In a new report from the U.S. International Trade Commission (USITC), concerns about global inequities accessing diagnostics and medicines for COVID-19 reveal that there are varied and divergent opinions on whether the intellectual property (IP) protections that support the development of new medicines may also act as a barrier to access, particularly in developing countries. In December 2022, U.S. Trade Representative Katherine Tai asked the USITC to respond and identify significant data and information gaps.
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.
Scientists at Washington University in St. Louis reported filing patent protection for their breath test that quickly identifies those infected with SARS-CoV-2, requires only one or two breaths to be performed, and provides results in less than a minute.
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.
Due to the continual emergence of SARS-CoV-2 mutants, there is an unmet clinical need for broad-spectrum treatments for COVID-19. A potential target for novel treatments is the S2 subunit of the SARS-CoV-2 spike (S) protein, which has been highly conserved across the different variants of the virus.
