There has been some interesting news from the clinic over the past week across biotech and medical devices. Here are some highlights that I found.
Moderna plants new solid tumor trials for cancer vaccine, weeds PD-1 work after review. Much of Moderna’s focus is on nabbing FDA approval for a respiratory syncytial virus vaccine, a decision expected in a matter of weeks. But clinical investments are also pouring into a late-stage cancer treatment.
Senseonics gets FDA clearance to pair CGM implant with insulin pumps. Analysts said the designation and planned one-year sensor could help Senseonics’ device appeal to more patients.
Cardinal Health receives FDA warning letter over unapproved syringes. The agency has recently increased scrutiny of plastic syringes made in China because of safety concerns, including blocking imports from two Chinese manufacturers.
Labcorp nets companion diagnostic approval for Pfizer’s hemophilia B gene therapy Beqvez
The FDA has handed a groundbreaking green light to the Apple Watch, allowing its atrial fibrillation tracking features to be employed in clinical studies. The watch’s sensor and software marked the first digital health product to be qualified under the agency’s Medical Device Development Tools program
GE HealthCare aims to provide neuroscientists and researchers with a clearer view into the human mind, by using a specialized, “premium” MRI machine to help explore the brain’s structure and function. The technology will help overcome the limitations that come with employing full-body machines for neuroscience imaging, especially when it comes to studying degenerative conditions such as Alzheimer’s disease as well as brain cancers and psychiatric disorders.
Calliditas Therapeutics‘ survival data salvage midphase cancer trial after primary endpoint miss. The Swedish biotech fell at the first obstacle on that timeworn path, seeing no change in tumor size, but bounced back up with early evidence of an effect on progression-free (PFS) and overall survival (OS).