Today’s biopharma news highlights how new data could reduce treatment burden, improve excipient information sharing, and shape future options for patients with difficult-to-treat cancers.
|Articles|November 15, 2002
- BioPharm International-11-01-2002
- Volume 15
- Issue 11
Survival Guide to FDA Inspections: Part 3, Responding to Observations
Author(s)Massoud Lavian, Paul W. Allen
by Massoud Lavian and Paul W. Allen, Clarkston Consulting
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Articles in this issue
almost 24 years ago
Inside Washington: Major Changes Ahead for FDAalmost 24 years ago
Bioinformatics Databases ? Questions of Copyrightalmost 24 years ago
European Editor's Report ? An Industry Comes of Agealmost 24 years ago
Guest Editorial: Back to the Beginningalmost 24 years ago
You Have Failed . . . A Case Study in Warning Letter RemediationAdvertisement
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Daiichi Sankyo and Merck pulled ifinatamab deruxtecan's FDA filing in small cell lung cancer after a 187-patient trial fell short.
IPEC’s EIP user guide streamlines information exchange and response times while increasing accuracy through standardization.
Insulin efsitora alfa-gobe (Onswik) cuts injections from 365 to 52 a year for adults with type 2 diabetes, per its new FDA approval.
Genentech is paying Earendil Labs $55 million upfront in a deal worth over $1.5 billion to develop bispecific antibodies for hard-to-treat cancers.
Acuitas CEO Dr Thomas Madden and NanoVation co-founder and president Dr Dominik Witzigmann discuss how LNP engineering is expanding genetic medicine applications to traditionally undruggable targets.
Guselkumab eased spinal pain, stiffness, and MRI-confirmed spinal inflammation in a 411-patient trial of psoriatic arthritis with axial involvement.
AstraZeneca's sBLA for durvalumab combined with neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer, based on the Phase 3 VOLGA trial, has a PDUFA date expected in the fourth quarter of 2026.
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