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Latest From Celltrion
Celltrion has received a positive opinion from the EMA’s CHMP for its Vegzelma bevacizumab biosimilar rival to Avastin, setting up the Korean firm to enter a competitive European market that already includes several bevacizumab biosimilars.
Keeping Track: Pediatric Approvals, Seres Starts C Diff Submission, And BMS Pulls Reblozyl sBLA Before Possible CRL
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
A few cases of COVID-19 relapse have Twitter abuzz about the need for data on Paxlovid’s effectiveness, particularly against the Omicron variant and in vaccinated individuals. Despite regulatory approval in India, the drug has not yet been included in treatment guidelines and a debate on recommended dosage now complicates matters
Celltrion has secured a US launch date for its higher-strength adalimumab biosimilar, Yuflyma, through a settlement with AbbVie. However, the company will face a number of other Humira rivals in 2023.