Current Editions
Amendment seeks disengagement with Chinese biotechs, attempts to address concerns that killed Biosecure
Politics, Policy & Law
Can the long-time neuropsych company couple its new management with a pivot to rare disease to climb back up the market cap tiers?
Product Development
Orforglipron delivers 11.5% placebo-adjusted weight loss, clean safety profile for first-in-class small molecule GLP-1R agonist
Product Development
Product Development
Five discontinuations include two assets tied to recent M&A deals
Emerging Company Profile
Netherlands-based newco aims to extend the concept beyond patients with homologous recombination deficiency
Guest Commentary
The agency must act with urgency and not be trapped by standards that can only be met in large indications
Data Byte
41% of deals analyzed by BioCentury involved a first-in-class asset
Twice the approvals of any other other month this year, bringing tally to 22
Despite some recent delays, median response time is one day before PDUFA
Discovery & Translation
BioCentury’s roundup of translational innovations also includes a new immunotherapy target and a strategy for programmable protein activation
Regulation
It will take FDA at least 24 months to review a dataset of 12 patients. Stealth doesn’t know if it can stay in business that long
Politics, Policy & Law
Haystack Project calls for Congress to reduce regulatory barriers to developing drugs for very rare, heterogeneous conditions
Finance
Plus: Public raises for Assembly, Sana and Shattuck
Management Tracks
A founding core member of the Broad Institute, David Altshuler will step aside next year
Biopharma Stock Performers
Use BioCentury's interactive dashboard to view top-performing biopharma stocks for the day and the week.
Product Development
Politics, Policy & Law
Management Tracks
BioCentury ISSN 1097-7201