IMU Biosciences Ltd. is working to transform society’s understanding of the immune system. The company’s platform maps the immune system at molecular, cellular and system levels, to unlock new insights into immune-related health and diseases, paving the way for clinical applications that could improve patient outcomes.
Detailed data are expected later, but partners Biontech SE and Duality Biologics Co. Ltd. are celebrating a phase III interim analysis readout demonstrating that HER2-targeting antibody-drug conjugate (ADC) trastuzumab pamirtecan hit the primary endpoint of progression-free survival in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy.
Quantum Surgical SAS has secured CE marking for the expanded use of its Epione robotic platform to treat bone tumors and metastases. The regulatory green light allows surgeons to use Epione to treat inoperable tumors which are difficult to reach due to their size or location at an early stage, in a simple and effective way.
The funding is in place for a phase IIb trial of its lead gut microbiome live biotherapeutic, after MRM Health NV closed a €55 million (US$64 million) series B round.
Phase III results from Sanofi SA’s study of amlitelimab in treating atopic dermatitis met the primary and key secondary endpoints, but investors took a step back.
Vicentra BV’s insulin patch pump, Kaleido, will soon reach more patients with diabetes after it raised $85 million in a series D funding round. The company said the Kaleido is among the smallest, lightest, and most precise insulin patch pumps available.
There have been numerous improvements in the treatment of cardiovascular disease since the European Society of Cardiology (ESC) first met in 1950, but unmet medical need remains and the science continues to advance, as delegates heard at the 75th annual meeting in Madrid, Spain, Aug. 29-Sept. 1.
The Danish-German Cardiogenic Shock trial found that men implanted with Johnson & Johnson’s Impella CP after experiencing a heart attack with cardiogenic shock gain 600 days of life, on average, compared to usual care at 10 years. The study demonstrated no benefit for women.
Cyted Health Ltd. raised $44 million in a series B financing round to expand the reach of Endosign, its capsule sponge technology, in the U.S. Endosign is a minimally invasive device used to collect cell samples from the esophagus for the early detection of esophageal diseases, offering the potential to transform early cancer detection and improve health outcomes.
The U.K. Medicines and Healthcare Products Regulatory Agency announced a new pilot program for modifications to clinical trials that allows for automatic approvals of those changes based on the risks those changes present.