Bio News

Replimune’s melanoma treatment RP1 received a 10-3 favorable vote on efficacy from an FDA advisory committee. The company claimed a response rate of 33.6%, but the FDA countered that the rate fell to 15.7% when noninjected lesions were excluded. The FDA will decide whether to approve the treatment by Aug. 2.

BIOBOOK TEAM
biobookmedia@biobook.co.krParagon Spin-Off Velaris Goes Public Through Reverse Merger With Alaunos
Syndax halts development of Niktimvo for pulmonary fibrosis; shares plunge 17%
BioNTech’s mRNA Cancer Vaccine Misses Primary Endpoint for Progression-Free Survival in Phase 3 Trial
Roche Signs $1.6 Billion Deal With China’s Rona for ALK7 Obesity Drug
Formycon and Zydus’ Keytruda Biosimilar Is First to Be Accepted for FDA Review
Pfizer Signs $500 Million Protein Degrader Deal With Enodia