FDA Accepts BLA for Merck’s Monoclonal Antibody for Infant Protection Against RSV
Merck announced this morning that the federal agency accepted the biologics license application (BLA) for clesrovimab (MK-1654), the company’s long-acting monoclonal antibody (mAb) designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season.1 “This regulatory milestone, along with promising results from our pivotal studies demonstrating efficacy in the prevention of […]
Targeting the C Diff Pathogen and Its Immune-Suppressing Toxins
In the next part of our conversation with Joseph Zackular, PhD the discussion centered on C difficile infections, the impact of antibiotics on the microbiome, and emerging approaches to treatment, including vaccines and monoclonal antibodies. One of the key takeaways is the potential of vaccination to prevent severe disease, even in recurrent infections, by overcoming […]
mRNA Vaccine Shows Potential for C difficile Infections
Joseph Zackular, PhD, an assistant professor at the Children’s Hospital of Philadelphia and the University of Pennsylvania, is leading research on Clostridioides difficile (C difficile) and the development of an mRNA vaccine. His recent work has shown promise in reducing mortality and improving outcomes for infections caused by this bacterium. In our recent interview, Zackular […]
Investigational Therapeutic for Recurrent C Difficile Reduces Antibiotic Resistant Genes
During the recent ID Week, Vedanta Biosciences shared data on its completed phase 2 CONSORTIUM study. The company reported its investigational live biotherapeutic product, VE303, an investigational treatment for recurrent C difficile was well tolerated, reduced the odds of C diff recurrence by >80% compared with placebo, colonized the gut well, and led to early […]
Unexplained “Dancing Disease” Affects Women in Uganda
Women in Uganda Image credits: Unsplash Health authorities in Uganda are investigating a mysterious illness, locally referred to as “Dinga Dinga,” a term derived from a local dialect meaning “shaking like dancing.” The disease, which has emerged in Bundibugyo district, is affecting mainly women and girls, leading to symptoms including fever and uncontrollable body shaking. […]
Investigational Hepatitis D Therapy Well-Tolerated, Safe for Chronic Disease at Week 48
Hepatitis D (HDV) only infects people who have hepatitis B. And this form of hepatitis continues to be the most virulent and can quickly decompensate to liver disease. Bulevirtide monotherapy is both safe and well-tolerated in patients with chronic hepatitis delta (CHD) through 48 weeks of use, according to recent findings.1 These findings resulted from a […]
Top 5 Infectious Disease New Stories Week of December 7-13
COVID-19 Therapy Roundtable: Addressing Inpatient Clinical Care In this week’s episode, of our COVID-19 Therapies roundtable, the panel discusses therapies and care for COVID-19 inpatients, focusing on mechanical ventilation, extracorporeal membrane oxygenation (ECMO), and remdesivir. Although hospitalizations have significantly decreased since the height of the pandemic, occasional waves of severe cases still require advanced interventions. […]
nChroma Bio Raises $75M to Advance Epigenetic Editing for Hepatitis B and D Cure
nChroma Bio is a biotechnology company focused on developing safe, precise in vivo genetic therapies Image credits: nChromaBio nChroma Bio was established following the merger of Chroma Medicine and Nvelop Therapeutics, combining expertise in epigenetic editing and non-viral, in vivo delivery systems. The new company announced the closing of an oversubscribed $75 million financing round, […]
Optimal Timing Determined for COVID-19 Vaccination Booster
An annual COVID-19 vaccination booster that precedes the highest anticipated prevalence in a region but is postponed in the event of a breakthrough infection was calculated to provide a 3-4-fold increase in protection from infection over less tailored seasonal recommendations, in a multi-country analysis incorporating longitudinal antibody and reinfection probabilities with regional projections of COVID-19 […]