Keeping Track: After COVID Delays, US FDA Approvals At Last For Daxxify, Rolvedon (But A CRL For Alvotech)
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Merck Reports Good News/Bad News In Latest Keytruda Readouts
With successful Phase III data, Merck will look to add biliary tract cancer to Keytruda’s label, but it will discontinue a Phase III study in prostate cancer after an interim analysis showed no survival benefit.
The Quality Lowdown: No Longer Stoppered By Pandemic, US FDA Finds Serious Problems
Some filling lines and API plants fared poorly in post-pandemic inspections, with shortfalls identified in sterility assurance and impurity control. Zhejiang Tianyu and System Kosmetik got warning letters. Alvotech, Cipla and Aurobindo got Form 483 reports posted on the FDA website.
Alvotech Bullish As Facility Deficiencies Hold Up Humira Biosimilar Again
Already approved in the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland, and Canada, Alvotech’s AVT02 high-concentration biosimilar to Humira (adalimumab) will not be greenlit by the USFDA until the Icelandic firm resolved manufacturing deficiencies.