Key Study Findings and Future Plans
Vaxart, Inc recently published complete data from its Phase 1b trial of its first-generation oral norovirus vaccine, demonstrating encouraging results in elderly adults. The study showed that the vaccine was capable of inducing strong antibody and T-cell responses in adults aged 55-80, a group known to experience weakened immune responses to traditional injectable vaccines. The […]
Cautionary Tale Associated in Trial With Rare Error in Cox Regression
The German company InflaRx has developed an investigational therapy, vilobelimab, which is being studied for SARS-CoV-2-induced acute respiratory distress syndrome (ARDS). Vilobelimab is a first-in-class monoclonal antihuman complement factor C5a antibody. In one of its trials, the FDA recommended that the company use a site stratification adjustment. “We had the FDA recommending us to do […]
Vaxart Phase 1b Trial Shows 100% Increase in Serum Anti-VP1 IgA in Elderly Adults with Oral Norovirus Vaccine
Image credits: Vaxart Inc Vaxart, Inc announced the publication of complete data from its Phase 1b trial of its first-generation oral pill norovirus vaccine candidate in elderly adults. The trial demonstrated the vaccine’s ability to induce strong antibody and T-cell responses in adults aged 55-80, a population known to experience age-related declines in immune responses […]
Texas Outbreak Increases, Northeast Reports Cases, CDC Deployed to Help
On Tuesday, the Texas Department of State Health Services provided an update on the measles outbreak in there. Authorities reported there were 159 cases have been identified with 22 of the patients being hospitalized in western counties in the state. Gaines county has reported the highest number of cases with 107. There has been 1 […]
Invivyd’s Monoclonal Antibody Neutralizes Against Dominant COVID-19 Strain
Invivyd’s Chief Scientific Officer Robert Allen, PhDImage credit: Invivyd Today, Waltham, Mass.-based biopharmaceutical company,Invivyd, announced its monoclonal antibody, pemivibart (Pemgarda), continued to demonstrate neutralizing activity against the dominant strain of COVID-19, LP81. The variant did not generate any meaningful change to the neutralization activity of pemivibart or VYD2311, the company’s next generation COVID-19 monoclonal antibody […]
FDA Pauses BioNTech’s Malaria Vaccine Trial Amid Broader Vaccine Challenges
The FDA has paused BioNTech’s Phase I/IIa trial of its experimental malaria vaccine, BNT165e, due to unspecified concerns, the company confirmed in an SEC filing on Monday. BioNTech is working with the FDA to address the agency’s requests, though specific details have not been disclosed. Both parties are collaborating to determine the next steps for […]
Ivermectin Does Not Reach Primary Endpoint in Burkina Faso Malaria Trial
A large clinical trial in Burkina Faso found that repeated high-dose ivermectin mass drug administration (MDA) did not significantly reduce malaria incidence in children when integrated with seasonal malaria chemoprevention (SMC). The study, published in The Lancet, evaluated ivermectin’s safety and efficacy in killing malaria-carrying mosquitoes that feed on treated individuals. Despite its safety and […]
Global Guideline on Candidiasis, Part II: Treatments
Oliver Cornely Image credits: CECAD Cologne A new global guideline for management of candidiasis includes treatment recommendations for several clinical circumstances including prophylaxis for at-risk patients, and targeting particular sites of infection.1 The guideline was developed by the European Confederation for Medical Mycology (ECMM) in collaboration with the American Society of Microbiology(ASM) and the International […]
Insights from Phase 3 Trial in Burkina Faso on Ivermectin’s Role in Malaria Control
A large clinical trial in Burkina Faso found that repeated high-dose ivermectin mass drug administration (MDA) did not significantly reduce malaria incidence in children when integrated with seasonal malaria chemoprevention (SMC). The study, published in The Lancet, evaluated ivermectin’s safety and efficacy in killing malaria-carrying mosquitoes that feed on treated individuals. While mosquito survival decreased […]
Synthetic Gel Shows Utility Across ABSSSI, Company Sees Other Indications
Skin and soft tissue infections, which include acute bacterial skin and skin structure infections (ABSSSI), continue to be challenging. It has been estimated to cause 3.4 million emergency department visits1 and cost roughly $4.5 billion in the US.2 One of the ongoing challenges in treating these troublesome infections is multidrug resistance especially with gram-negative pathogens. Looking […]
