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.
|Articles|June 11, 2008
Curtis Rosebraugh Appointed Director of the FDA’s Office of Drug Evaluation II
Author(s)BioPharm International Editors
Curtis (Curt) Rosebraugh, MD, has been appointed as the new director of the US Food and Drug Administration’s (FDA) Office of Drug Evaluation II.
Advertisement
Curtis (Curt) Rosebraugh, MD, has been appointed as the new director of the US Food and Drug Administration’s (FDA) Office of Drug Evaluation II. In 2000, Rosebraugh joined the FDA as a medical officer in the Division of Pulmonary and Allergy Drugs Products. From 2003–2005, he served as the deputy director of the Office of Nonprescription Products and was acting director of the Division of Nonprescription Clinical Evaluation in that office. In 2005, he became deputy director of the Office of Drug Evaluation II and became acting director in September 2007.
Advertisement
Related to this article
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.
Novartis has secured an exclusive worldwide license to ABO2203, Abogen's investigational mRNA-encoded CD19xCD3 T-cell engager designed to produce the bispecific inside the body to reset B cells in autoimmune disease. The agreement also includes options on other programs built on Abogen's RNA platform.
The 15-month project could let living cell therapies ship and store at room temperature, cutting cold-chain costs that limit patient access.
A planned phase 3 trial will test the TROP2 ADC and PD-1/VEGF bispecific together in 1st-line triple-negative breast cancer.
Former FDA oncology reviewer Paz Vellanki, MD, PhD, of Precision for Medicine, discusses how CDER's ARC program supports novel end points such as ctDNA for rare diseases and why sponsors should engage FDA early.
Following an FDA meeting, Wave Life Sciences plans a single 2-year registrational trial of WVE-006, its GalNAc-conjugated RNA editing oligonucleotide for alpha-1 antitrypsin deficiency, with a 1-year interim analysis that could support accelerated approval based on biomarkers.
Advertisement
Advertisement