Keeping Track: New Claims For Tukysa, Brukinsa; US FDA Wants More Patients To Support Donanemab, Pediatric Airsupra Bids
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
You may also be interested in...
Products Targeting Alzheimer's, Duchenne & COVID-19 Among New EU Filings
EU marketing authorization applications have been submitted for a number of new drugs, including Eli Lilly’s donanemab, Italfarmaco's givinostat and Arcturus Therapeutics/CSL’s ARCT-154.
BeiGene’s Brukinsa Set To Take On Imbruvica With CLL Approval
The BTK inhibitor demonstrated superiority to AbbVie/J&J’s Imbruvica for overall response in relapsed/refractory CLL, in addition to hitting a progression-free survival endpoint versus chemotherapy in the first-line.
US FDA Rejects Lilly’s Bid For Donanemab Accelerated Approval In Early Alzheimer’s
More long-term data for donanemab needed, FDA says. Lilly plans to seek traditional approval for its amyloid-clearing antibody after the Phase III TRAILBLAZER-ALZ 2 trial reads out in Q2, but it loses important ground in reimbursement negotiations.