Novavax Seeks Full FDA Approval for COVID-19 Vaccine

In our recent interview with Novavax’s Chief Medical Officer, Robert Walker, MD, he discussed the company’s progress in obtaining full licensure for their COVID-19 vaccine. He said, “We’ve submitted a Biologics License Application (BLA) to the FDA to seek full licensure for our vaccine, which is currently available under Emergency Use Authorization (EUA). The PDUFA […]

New Meta-Analysis Highlights Most Effective Treatments for Clostridioides difficile Infection

A recent systematic review and network meta-analysis has examined the effectiveness of various treatments for Clostridioides difficile infection (CDI), a major cause of healthcare-associated diarrhea with significant morbidity and mortality. The study, led by researcher Dániel Steve Bednárik, consultant physcian and gastroenterologist, and his team, analyzed 73 randomized controlled trials (RCTs) evaluating 28 different CDI […]

Novavax’s Updated COVID-19 Vaccine Demonstrates Enhanced Immune Response in Recent Study

Interim results from a Phase 2/3 study of the Novavax COVID-19 vaccine, NVX-CoV2601, demonstrate significant improvements in immune response, suggesting its potential as an effective booster for adults in the U.S. The study, which was conducted between September 2023 and January 2024, showed that NVX-CoV2601, based on a recombinant spike protein from the Omicron XBB.1.5 […]

Harnessing the Power of AI in the Fight Against Antimicrobial Resistance

Image credit: Tara Winstead, Pexels Much of the conversations around artificial intelligence (AI) as of late has been in the realm of what are the promise and perils it could bring. Can it increase the risk of bioterrorism or help us combat disease?1 In the midst of this, sits the growing threat of antimicrobial resistance […]

Azole Fungicides in Agriculture Linked to Rising Resistance in Aspergillus fumigatus

Dominique L Monnet, PharmD, PhD Image credits: LinkedIn The European Food Safety Authority (EFSA) and several European agencies have assessed the impact of non-medical uses of azole fungicides on the emergence of azole-resistant Aspergillus species. Their review highlights concerns over environmental exposure to azoles, which may contribute to resistance in Aspergillus, particularly A fumigatus.1 According […]

Carbapenem Resistant Enterobacterales Poses a Significant Threat

Yesterday, the European Center for Disease Prevention and Control (ECDC) published an assessment warning the public that the probability of carbapenem-resistant Enterobacterales (CRE) was spreading in the European Union/European Economic Area (EU/EEA) countries was high. The last update of ECDC’s rapid risk assessment on CRE was published in 2019. ECDC said the epidemiological situation has […]

Invivyd Tracks SARS-CoV-2 Evolution, Prepares for Future Variants

Invivyd, Inc announced that its pipeline candidate, VYD2311, demonstrated promising neutralizing activity against the dominant SARS-CoV-2 variant XEC. This result aligns with earlier findings for the variant KP.3.1.1, further supporting the effectiveness of Invivyd’s monoclonal antibodies, including PEMGARDA™ (pemivibart). Both antibodies are designed to provide long-term protection against SARS-CoV-2 despite viral mutations. Invivyd has submitted […]

Levofloxacin Protects TB Contacts in Meta-Analysis but not RCTs

Image credit: Anna Shvets An extended course of daily levofloxacin was found effective in preventing household contacts of persons with multidrug-resistant tuberculosis (TB) from developing the disease, in a meta-analysis of a controlled trial with adults and another with children.1-3 The statistically significant separation from placebo in the meta-analysis did not occur, however, in the […]