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BioCentury | Mar 20, 2025
Regulation
Amvuttra’s label expansion lifts Alnylam toward five-year goals
Non-GAAP profitability in sight as RNAi therapeutic adds cardiomyopathy indication alongside previous amyloidosis approval
BioCentury | Mar 19, 2025
Management Tracks
CFO Brian Stephenson exits Bridgebio
Plus: CEO Edward Kayne steps down at Stoke, and updates from Collegium, Pyxis, Recursion and Tonix
BioCentury | Mar 14, 2025
Data Byte
Ten PDUFA dates on FDA’s March agenda
Upcoming decisions include a label expansion for Alnylam’s Amvuttra, a new siRNA therapy for hemophilia, and more
BioCentury | Feb 28, 2025
Product Development
Intellia: Balancing in vivo risk with validated targets
Sticking with genetic targets validated by Alnylam and Ionis gave Intellia confidence to take CRISPR in vivo
BioCentury | Feb 25, 2025
Product Development
Indication selection: Lessons learned from the CRISPR-Cas9 story
Founding CEOs of gene editing companies discuss their pipeline strategies and lessons learned
BioCentury | Jan 28, 2025
Distillery Therapeutics
Placenta-targeting LNP delivering VEGF mRNA for preeclampsia
BioCentury | Jan 18, 2025
Product Development
2025 catalysts: New modality showdowns
Genetic therapies compete in the same indications, as degraders come of age
BioCentury | Jan 6, 2025
Regulation
2024 Approvals: Where are the new modalities?
Last year’s new drug approvals by FDA reflect the continued focus on best-in-class drug development
BioCentury | Dec 14, 2024
Data Byte
BridgeBio, Geron follow U.S. approvals with nods from EMA’s CHMP
November meeting highlights also include a pair of firsts for rare genetic diseases, and label expansions for eight approved drugs
BioCentury | Dec 11, 2024
Data Byte
November’s FDA approvals include Autolus’ CD19 CAR T
Plus: BridgeBio’s Attruby approved for ATTR-CM, PTC’s gene therapy for AADC deficiency, and Gilead withdrew Trodelvy for urothelial cancer
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