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Demonstration of Major Therapeutic Advantage From a Review of EU Conditional Marketing Authorizations in Oncology and Hematology.
Clin Pharmacol Ther
January 2025
European Medicines Agency, Amsterdam, The Netherlands.
In the EU, conditional marketing authorization is a pragmatic tool for early approval of a medicine that fulfills an unmet medical need. In the pharmaceutical legislation, an unmet medical need means that a condition lacks a satisfactory method for diagnosis, prevention, or treatment. If such satisfactory methods exist, the new medicinal product must hold a major therapeutic advantage for those affected, meaning that it must demonstrate an improvement in efficacy or safety over existing methods or, in exceptional cases, a major improvement in patient care.
View Article and Find Full Text PDFTypical Atrial Flutter: A Practical Review.
J Cardiovasc Electrophysiol
January 2025
Cardiology Division, Geneva University Hospitals, Geneva, Switzerland.
Typical atrial flutter (AFL), defined as cavotricuspid isthmus (CTI)-dependent macro-re-entrant atrial tachycardia, often causes debilitating symptoms, and is associated with increased incidence of atrial fibrillation, stroke, heart failure, and death. Typical AFL occurs in patients with atrial remodeling and shares risk factors with atrial fibrillation. It is also common in patients with a history of prior heart surgery or catheter ablation.
View Article and Find Full Text PDFExploration of the feasibility of clinical application of phage treatment for multidrug-resistant -induced pulmonary infection.
Emerg Microbes Infect
January 2025
Department of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Shenzhen Third People's Hospital, Shenzhen, Guangdong Province 518112, China.
() commonly induces refractory infection due to its multidrug-resistant nature. To date, there have been no reports on the application of phage treatment for infection. This study was conducted to explore the feasibility of phage application in treating refractory infection by collaborating with a 59-year-old male patient with a pulmonary infection of multidrug-resistant Our experiments included three domains: ) selection of the appropriate phage, ) verification of the efficacy and safety of the selected phage, ) confirmation of phage-bacteria interactions.
View Article and Find Full Text PDFEnhanced safety and efficacy profile of CD40 antibody upon encapsulation in pHe-triggered membrane-adhesive nanoliposomes.
Nanomedicine (Lond)
January 2025
Department of Pharmaceutical Sciences, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, MI, USA.
Aim: To develop pH (pHe)-triggered membrane adhesive nanoliposome (pHTANL) of CD40a to enhance anti-tumor activity in pancreatic cancer while reducing systemic toxicity.
Materials And Methods: A small library of nanoliposomes (NL) with various lipid compositions were synthesized to prepare pH (pHe)-triggered membrane adhesive nanoliposome (pHTANL). Physical and functional characterization of pHTANL-CD40a was performed via dynamic light scattering (DLS), Transmission Electron Microscopy (TEM), confocal microscopy, and flow cytometry.
Safety and clinical efficacy of neoadjuvant chemoradiation therapy with immunotherapy for organ preservation in ultra-low rectal cancer: preliminary results of the CHOICE-I trial: a prospective cohort study.
Int J Surg
January 2025
Department of Colorectal Surgery.
Objective: To explore the safety and efficacy of neoadjuvant chemoradiotherapy (nCRT) combined with a PD-1 antibody in improving complete clinical response (cCR) and organ preservation in patients with ultra-low rectal cancer.
Methods: This was a prospective phase II, single-arm, open-label trial. Patients with confirmed pMMR status T1-3aN0-1M0 retcal adenocarcinoma were included.
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