The latest global regulatory news, changes and updates affecting biopharma, including: WHO maps end of the road for some tropical diseases; MHRA updates import licensing guidance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alzecure, Apollomics, Bavarian Nordic, Halozyme, Janssen, Mycovia, Neonmind, Valeo, Vasomune.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA warning letter to company promoting test kits.
Varian Medical Systems Inc. has invested $10 million in and inked a collaboration agreement with Cota Inc., a Boston-based curator of oncology clinical data. The radiation oncology company will now offer its customers access to Cota’s oncology real-world analytics and data curation services, which aggregate electronic health record (EHR) data to yield meaningful insights.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angiocrine, Bioxcel, Gyroscope, Inventiva, Sebela, Sorrento, Surface.