Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating. Now, though, that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? After all, the world — such as it is — continues to spin. So to nudge it in a better direction, we are relying, as always, on a cuppa stimulation. Our choice today is blueberry hibiscus. Of course, you are welcome to join us. Meanwhile, here are a few items of interest. Best of luck accomplishing your goals, and we hope you conquer the world. And, of course, do keep in touch. …
Vaxcyte disclosed that its experimental pneumococcal vaccine hit the primary endpoints in a Phase 3 clinical trial, setting up a competition with Pfizer and Merck, STAT writes. Vaxcyte’s shot, VAX-31, is designed to protect against 31 serotypes, or strains, of bacteria that can cause pneumococcal disease, including pneumonia, compared to 20 strains for Pfizer’s Prevnar and 21 strains for Merck’s Capvaxive. The company needs two more trials to deliver results before it can file for approval: a study looking at VAX-31 administered alongside an influenza vaccine and a study in adults who previously received a different pneumococcal shot.
The U.S. Food and Drug Administration has extended its review of an experimental hemophilia A drug from Novo Nordisk due to ongoing remediation work at a manufacturing facility, Reuters notes. Novo had submitted the application for the drug, called denecimig, in September 2025 and was expecting an FDA decision in the third quarter of 2026. While the regulator has not yet set a new timeline for its decision, Novo said the FDA did not raise any concerns regarding the safety or effectiveness data from the drug’s clinical trials. Novo added that the manufacturing site issues do not impact any of its other medicines currently on the market.
Continue to STAT+ to read the full story…
