The News in a Nutshell
The News in a Nutshell
CellSeed Europe has withdrawn its application to the European Medicines Agency for the marketing authorization of OraNera (previously known as...
Join thousands of industry professionals who rely on Scrip for daily insights
Already a subscriber?
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.
CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
The updated US FDA label modifies dose titration based on TRAILBLAZER-ALZ 6, a study that showed a more gradual rise in dosing levels reduced ARIA-E incidence without reducing amyloid clearance.
Joshi joins the parent company of Citeline, which houses flagship publications Scrip and Pink Sheet, to focus on AI, business harmonization and long-term growth.
The UK firm's chronic obstructive pulmonary drug Ohtuvayre has been enjoying a stellar launch.
