Alexion’s ravulizumab won accelerated approval to reduce proteinuria in adults with IgA nephropathy after the Phase 3 I CAN trial showed a 43.4% placebo-adjusted reduction at Week 34.
|Articles|November 5, 2013
FDA Releases Pulmonary Tuberculosis Guidance
Author(s)BioPharm International Editors
FDA releases guidance on pulmonary tuberculosis drugs.
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FDA has released a draft guidance,
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Nuravax will test AV-1959R in a 160-adult phase 2 trial to see whether the amyloid vaccine can prevent Alzheimer disease before symptoms begin.
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.
Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains where cold-chain planning still breaks down and why biopharma supply chain leaders should use AI to act on data sooner, with humans making the final call.
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.
AVT29, a proposed aflibercept biosimilar to Eylea 8 mg, could extend retinal disease treatment intervals to 16 weeks, versus 8 weeks today.
Nathan Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
The FDA grants accelerated approval to Ultomiris for IgA nephropathy, Alcon acquires Neurotech and its MacTel cell therapy for $550 million, and BioNTech and Bristol Myers Squibb add Trodelvy to a phase 3 trial in triple-negative breast cancer.
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