Survodutide advances metabolic disease treatment, while biosimilar capacity expands, FDA delays hemophilia review, and lupus data support next steps.
|Articles|November 15, 2002
- BioPharm International-11-01-2002
- Volume 15
- Issue 11
You Have Failed . . . A Case Study in Warning Letter Remediation
by Joseph Noferi, Edward R. Arling, Ralph L. Dillon, and Mikael Blomqvist, Pharmacia An FDA Warning Letter can be a business disaster. This case study tracks a company from receipt of an FD 483 ? that did not find contamination, but only the potential for contamination ? to 18 months later when the facility received a clean bill of health. What it did to get there ? and what it learned ? may keep your site from losing its operating freedom.
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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
Survival Guide to FDA Inspections: Part 3, Responding to ObservationsAdvertisement
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Litifilimab extended skin responses through 52 weeks in phase 2 AMETHYST data in cutaneous lupus erythematosus, with phase 3 results expected in 2027.
Manufacturing remediation, not efficacy or safety data, is delaying US approval of Novo's h+emophilia A therapy denecimig.
Doubled drug substance capacity at Alvotech's Reykjavik, Iceland, site aims to secure steady US supply of the Humira biosimilar Simlandi.
The glucagon/GLP-1 dual agonist hit both weight loss endpoints in phase 3, though gastrointestinal discontinuations and competitor data temper the readout.
CaseBioscience joins an ARPA-H effort to develop room-temperature cell therapy preservation, Novartis licenses an mRNA-encoded T-cell engager from Abogen, and AstraZeneca, Daiichi Sankyo, and Summit plan to combine Datroway with ivonescimab.
LumaLex Law's Dustin Robinson explains why retatrutide compounding remains illegal regardless of the Seventh Circuit's pending classification ruling.
Artiva Biotherapeutics will present data on AlloNK, an allogeneic, non-genetically modified NK cell therapy given with rituximab, in refractory rheumatoid arthritis, Sjögren disease and systemic sclerosis at ACR Convergence 2026, ahead of a planned phase 3 trial in rheumatoid arthritis.
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