The FDA grants accelerated approval to dostarlimab for rectal cancer, Lilly reports one-year remission data for pediatric ulcerative colitis, and Johnson & Johnson shares longer-term fistula remission results for Tremfya.
|Articles|November 1, 2012
- BioPharm International-11-01-2012
- Volume 25
- Issue 11
BioPharm International, November 2012 Issue (PDF)
Biosimilars : New Guidelines Set for Monoclonal Antibodies
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The Transformation to Process-Centered Organizationalmost 14 years ago
Considerations for Scale-Up of Stem-Cell Culturesalmost 14 years ago
Creating a Holistic Procurement Systemalmost 14 years ago
Product Characterization: A Primeralmost 14 years ago
A 25-Year Retrospective on Protein Recovery through Membrane Filtersalmost 14 years ago
Assay Development and Method Validation Essentialsalmost 14 years ago
Discovery Pipeline: Improved Delivery of RNA Vaccinesalmost 14 years ago
How to Manage Effective Leadership when Change is the Only Constantalmost 14 years ago
Product Analysis Key to Biosimilar DevelopmentAdvertisement
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Accelerated approval for dostarlimab-gxly (Jemperli) pairs a single-arm phase 2 dataset with an FDA-authorized biomarker test and confirmatory requirements.
BMS's Dr Nathan Pennell outlines how biomarker testing barriers and trial diversity affect patient access to targeted oncology drugs.
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.
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.
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