University of Antwerp

FRIDAY, Feb. 27, 2026 -- Perioperative enfortumab vedotin plus pembrolizumab and surgery lead to significantly better outcomes among patients with muscle-invasive bladder cancer who are ineligible for cisplatin -based chemotherapy compared with surgery alone, according to a study published online Feb. 18 in the New England Journal of Medicine . Christof Vulsteke, M.D., Ph.D., from Antwerp University in Belgium, and colleagues assessed whether perioperative therapy may improve outcomes among patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. The analysis included 344 participants randomly assigned to perioperative (neoadjuvant and adjuvant) enfortumab vedotin-pembrolizumab (170 patients) or surgery alone (control; 174 patients). The researchers found that at two years, estimated event-free survival was 74.7 percent in the enfortumab vedotin-pembrolizumab group versus 39.4 percent in the control group (hazard ratio for an event or death, 0.40). Estimated overall survival was 79.7 and 63.1 percent, respectively (hazard ratio for death, 0.50). A pathological complete response was achieved in 57.1 percent in the enfortumab vedotin-pembrolizumab group and 8.6 percent in the control group. All participants in the enfortumab vedotin-pembrolizumab group experienced adverse events (grade ≥3, 71.3 percent; grade ≥3 drug-related, 45.5 percent), as did 64.8 percent of patients in the control group (grade ≥3, 45.9 percent). "On the basis of this trial, the Food and Drug Administration approved neoadjuvant followed by adjuvant enfortumab vedotin plus pembrolizumab after cystectomy as a new treatment option for adults with muscle-invasive bladder cancer who are ineligible for cisplatin," the authors write. Several authors disclosed ties to pharmaceutical companies, including Merck Sharp and Dohme, which manufactures pembrolizumab and funded the study. Abstract/Full Text (subscription or payment may be required) Editorial (subscription or payment may be required)

COPENHAGEN, Denmark I June 26, 2025 I Bavarian Nordic A/S (OMX: BAVA) announced today the initiation of the first of two clinical trials designed to support approval and use of the MVA-BN ® mpox/smallpox vaccine in vulnerable populations: infants under 2 years of age and pregnant and breastfeeding women The first participants have been vaccinated in a study ( NCT06844487 ), evaluating the safety and immunogenicity of MVA-BN in 344 infants aged 4-24 months. Recruitment has also started in a second study ( NCT06844500 ), which is planned to enrol 359 women (pregnant or breastfeeding), also to be evaluated for safety and immunogenicity of MVA-BN. Both studies are conducted in the Democratic Republic of Congo (DRC), the epicentre of the ongoing mpox outbreak, where infants and pregnant women remain highly vulnerable to mpox. Paul Chaplin, President & CEO of Bavarian Nordic , said: “ Through partnerships we have made significant advances already by expanding access to our mpox vaccine for children and adolescents. These new studies will fill the gap by providing important data about the use of MVA-BN in infants and pregnant women, and we applaud the study partners as well as the funding partners, EDCTP3 and CEPI for supporting this important work which could help support a label expansion for MVA-BN to include the most vulnerable populations. ” Both studies are part of the PregInPoxVac research project, led by the University of Antwerp and the University of Kinshasa. The project is further supported by partners in Kenya (ACE Research) and Italy (Penta Foundation), funded by the European Union Global Health EDCTP3, the Coalition for Epidemic Preparedness Innovations (CEPI), and Bavarian Nordic. In addition, Bavarian Nordic is sponsoring a trial of MVA-BN in children aged 2-11 years, which has received funding support from CEPI. Topline results from this trial ( NCT06549530 ) are anticipated in the third quarter of 2025. Once full results become available, these could potentially support regulatory approval of MVA-BN for younger children. About the mpox vaccine MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is the only non-replicating mpox vaccine approved in the U.S., Switzerland, Singapore and Mexico (marketed as JYNNEOS ® ), Canada (marketed as IMVAMUNE ® ), and the EU/EAA and United Kingdom (marketed as IMVANEX ® ). Originally developed as a smallpox vaccine in collaboration with the U.S. government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines, MVA-BN has been indicated for use in the general population in individuals considered at risk for smallpox or mpox infection. About Bavarian Nordic Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit www.bavarian-nordic.com . SOURCE: Bavarian Nordic

TUESDAY, April 8, 2025 -- A non-intoxicating extract of cannabis appears to help children and teenagers with autism, a new study says. Cannabidiol (CBD) enhanced social responsiveness, reduced disruptive behavior and alleviated anxiety among kids with autism, researchers reported today at the European Congress of Psychiatry in Madrid. “The global population prevalence of autism spectrum disorder diagnosis amongst children and adolescents is growing, but many treatment pathways are not effective,” lead researcher Dr. Lara Branco , a psychiatrist at the University of São Paulo in Brazil, said in a news release. “It is promising to see the effect of CBD cannabis extract on the study participants,” she continued. For the study, researchers pooled data from three previous clinical trials looking into the use of CBD extracts to treat 276 children with autism. Their average age was 10-1/2 years old. Cannabidiol is the second most prevalent active ingredient in marijuana, according to Harvard Medical School. Unlike THC, CBD does not cause intoxication, but researchers believe it can produce health benefits by acting upon cannabinoid receptors throughout the brain and body. The new results show that CBD does indeed appear to have a calming effect on children with autism, helping them become more responsive to others and less anxious. CBD also appeared to improve kids’ sleep quality, although those results were not statistically significant. “ASD can be extremely frustrating for all involved; parents of children and adolescents with the disorder, the treating clinicians, and of course the children and adolescents themselves,” European Psychiatric Association President Dr. Geert Dom said in a news release. “A large part of this frustration is down to finding a viable treatment option that works to reduce symptoms,” added Dom, a professor of psychiatry at the University of Antwerp in Belgium. “It is with delight that we see the results of this meta-analysis and we hope to see further research into this so we can move towards a solution to the unmet need within this community." Branco, however, emphasized that more research into CBD is needed before it can be considered as a treatment for autism. “There still needs to be considerable focus on further research with larger trials to clarify its efficacy and safety in managing ASD,” she said. Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed journal. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.