Just as the U.S. mpox public health emergency declaration is about to end, the FDA is releasing a draft guidance on developing drugs and biologics to treat infections caused by the virus.
The U.S. Department of Health and Human Services received low marks on its latest Government Accountability Office (GAO) report card for its oversight of high-risk research involving potential pandemic pathogens, but legislative fixes might be necessary to ensure that all the gaps are closed.
A year and a half gone, two HIV vaccine studies shut down. That’s the case with the Janssen Pharmaceutical Cos. of Johnson & Johnson as the phase III Mosaico study of its HIV vaccine regimen was not effective in preventing infection compared to placebo. Based on a data and safety monitoring board’s report saying the study was not expected to hit its primary endpoint, Janssen discontinued the clinical trial more than a year ahead of its estimated March 2024 completion date.
Now there are three. Moderna Inc. has posted strong phase III study data on its mRNA respiratory syncytial virus (RSV) vaccine, keeping pace with Pfizer Inc. and GSK plc’s candidates, which have May PDUFA dates. Moderna’s top-line results of the ConquerRSV pivotal efficacy study of mRNA-1345 show the vaccine hit its primary efficacy endpoints of 83.7% against RSV-associated lower respiratory tract disease in older adults.
Following Therapeutic Goods Administration approval of its first-generation donor-derived microbiome-based therapy, Biomictra, for recurrent Clostridioides difficile infection, Australia’s Biomebank is scaling up to meet increasing global demand for fecal microbiota products and is developing a more scalable second-generation synthetic product.
Although strides have been made in the space, biopharma’s hunt for a wider net to cast in vaccines for pneumococcal disease has recruited the likes of Vaxcyte Inc., GSK plc and Merck & Co. Inc., each racing for a candidate with improved valence.
The success of the U.K. COVID-19 genomics consortium in large-scale sequencing, tracking variants of concern, establishing rates of transmissibility and informing public health decision-making during the pandemic, is to be extended to the monitoring of other respiratory viruses.
Raynovent Biotech Co. Ltd. has raised ¥370 million (US$54 million) in a series C round to further develop candidates in the field of respiratory and metabolic diseases. Funds will be used to accelerate clinical trials of lead candidates in its pipeline, as well as to prepare for the commercialization of oral pills to treat COVID-19 and influenza A virus.
After comparing the response to the two types of vaccines for the respiratory syncytial virus (RSV) based on its fusion protein (F), prefusion (pre-F) versus postfusion (post-F) vaccines, scientists at the National Institutes of Health (NIH) and Astrazeneca plc have demonstrated that targeting the pre-F protein led to better protection. No more bets on RSV immunization based on the post-F protein of the virus. Laboratories can now bet all on red for the pre-F technology.
Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, failed to meet the primary endpoint of noninferiority compared to Roche Holding AG’s valganciclovir in the phase III Aurora study for cytomegalovirus (CMV) infection in hematopoietic stem cell transplant recipients. The multicenter, randomized, double-blind, double-dummy, active-controlled study was to form the basis for a future label expansion for the therapy.
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