In the phase 3 SHINE-2 trial, half of pediatric patients who responded to mirikizumab induction were in clinical remission at week 52. Lilly plans to file for a pediatric UC label expansion.
|Articles|January 15, 2002
- BioPharm International-01-01-2002
- Volume 15
- Issue 1
Information Age Audits
by Joseph F. Noferi, Daniel E. Worden, and Edward R. Arling Understanding the reach of 21 CFR Part 11 is the first step to assessing its impact. To protect your company, you need integrated quality audit solutions to evaluate the underlying validation of your electronic data.
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Inside Washington: Biotechnology in the Limelight, the Year Aheadalmost 25 years ago
Your Vested Interests: The War of the Westalmost 25 years ago
Statistics for Laboratory Method Comparison Studiesalmost 25 years ago
From the Editor: Farewell to 2001 . . . Our Biotech Odyssey Continuesalmost 25 years ago
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Guselkumab (Tremfya) sustained perianal fistula healing through 1 year in Crohn disease, with remission climbing to 35% in one FUZION dosing arm.
Roche will take ex-China development of Hansoh’s two preclinical ADCs and multiple programs against Roche-proposed targets once Hansoh completes global phase 1a trials. The deal includes $400 million upfront and more than $15 billion in potential milestones.
Cemiplimab's proposed EU regimen could cut Libtayo infusion visits from every 3 weeks to every 6 weeks, trimming infusion time by up to half.
Opus Genetics reports sustained vision gains with gene therapy, the FDA approves Roche’s Enspryng for at-home treatment of thyroid eye disease, and Estuary Biotherapeutics launches with $103 million to develop gene therapies for polycystic kidney disease.
When large pharmaceutical companies deprioritize drug candidates, smaller developers may license or acquire them, but due diligence, deal structure, and trial planning determine whether a program can move forward.
Interim phase 1/2 data presented at Retina in Rio 2026 showed sustained visual improvements with Opus Genetics’ AAV8 gene therapy OPGx-LCA5 and improved retinal sensitivity with OPGx-BEST1 in inherited retinal diseases.
The FDA approved Roche's satralizumab (Enspryng), an IL-6 receptor-targeting monoclonal antibody, for adults with thyroid eye disease based on the Phase 3 SatraGO-1 and SatraGO-2 trials, giving patients the first at-home subcutaneous treatment option.
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