DUBLIN – Ose Immunotherapeutics SA finds itself in the difficult place of hitting the primary endpoint of the first part of a phase III trial of Tedopi, a therapeutic vaccine, in non-small-cell lung cancer (NSCLC) while having to terminate the study without completing the crucial second part.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytosorbents, Enlightenvue, Qiagen, Siemens Healthineers.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affimed, Applied, Celularity, Fera, Nicox, Pfizer, Pharmamar, Seattle Genetics.
An artificial intelligence-based system can accurately detect COVID-19 using thoracic CT scans in patients with respiratory symptoms, according to a preprint study published on arXiv.org. The system can also help monitor patients with the disease. Other teams have employed AI to speed diagnosis and develop clarity on the signature appearance of the disease in the lungs of symptomatic patients.
Cerus Corp., of Concord, Calif., is teaming up with several collaborators in its home state, with an eye toward optimizing convalescent plasma therapy for COVID-19 patients.
Charleston, S.C.-based startup ABM Respiratory Care has received U.S. FDA clearance for its first product, an airway clearance system known as Biwaze Cough. The portable device helps to remove secretions for people who are unable to cough or clear away secretions effectively on their own due to injury or disease.