Immunologic Factor
Servier Pays $210M Upfront for Ex-US Rights to Ideaya’s PKC Inhibitor Darovasertib
Servier; Ideaya Biosciences; darovasertib; protein kinase C inhibitor; PKC inhibitor; uveal melanoma; oncology licensing deal; clinical trials; milestone payments; royalties
Vinay Prasad Details New Approach to COVID-19 Vaccine Approvals in Recent FDA Memos
Vinay Prasad; COVID-19 vaccine; FDA; vaccine approval; children; Spikevax; regulatory decisions; vaccine safety; evidence; risk-benefit analysis
Zymeworks Halts Development of ZW171 T-cell Engager After Phase 1 Trial Assesses Benefit-Risk Profile
Zymeworks; ZW171; T-cell engager; mesothelin; cancer; clinical trial; drug development; benefit-risk profile; dose-limiting toxicity
Zenas BioPharma Secures $300M Royalty Deal for Obexelimab FDA Approvals
Zenas BioPharma; Royalty Pharma; Obexelimab; autoimmune diseases; IgG4-Related Disease; Systemic Lupus Erythematosus; FDA approval; royalty agreement; Phase 3 INDIGO trial; funding
J&J Halts Phase 2a Rheumatoid Arthritis Program for Imaavy (Nipocalimab) after Lackluster Results
Johnson & Johnson; Imaavy; nipocalimab; rheumatoid arthritis; Phase 2a trial; DAISY study; clinical trial failure; anti-TNFα therapy; autoimmune diseases
FDA Approves Updated COVID-19 Shots from Pfizer, Moderna, Novavax with New Restrictions
FDA; COVID-19 vaccine; Pfizer; Moderna; Novavax; vaccine restrictions; high-risk groups; 2025-2026 booster; LP.8.1 sublineage
Outlook Therapeutics Faces New FDA Setback for First Ophthalmic Avastin Formulation
Outlook Therapeutics; Avastin; bevacizumab; Lytenava; wet AMD; FDA rejection; NORSE EIGHT; BLA resubmission; ophthalmic formulation; clinical trial
Vinay Prasad Explains FDA’s Revocation of Pfizer’s Covid Vaccine EUA for Children
FDA; Pfizer; COVID-19 vaccine; emergency use authorization (EUA); children; Vinay Prasad; vaccine policy; risk-benefit analysis
CDC Staff and Medical Organization Liaisons Barred from New ACIP Covid-19 Working Group
CDC; ACIP; Covid-19; working group; staff exclusion; medical groups barred; vaccine policy; Robert F. Kennedy Jr.
Novartis Pays $30M Upfront to Leqembi Creator BioArctic for Access to Blood-Brain Barrier Technology
Novartis; BioArctic; BrainTransporter platform; blood-brain barrier; neurodegeneration; Leqembi; partnership; antibody; milestone payments; royalties