Biologically Active Substance
Bristol Myers Squibb Commits Up to $11B+ in Major BioNTech Solid Tumor Bispecific Antibody Deal
Bristol Myers Squibb; BioNTech; BNT327; bispecific antibody; solid tumors; PD-L1; VEGF-A; cancer immunotherapy; partnership; milestone payments
Bristol Myers Squibb Signs $11B Deal With BioNTech for Bispecific Cancer Antibody BNT327, Surpassing Recent Merck and Pfizer Moves
Bristol Myers Squibb; BioNTech; BNT327; bispecific antibody; immuno-oncology; cancer; PD-L1; VEGF-A; solid tumors; biotech partnerships
Sanofi, Regeneron’s IL-33 Drug Fails One of Two COPD Studies, Casting Doubt on FDA Approval Timeline
Sanofi; Regeneron; COPD; itepekimab; IL-33; Phase 3 trials; AERIFY-1; AERIFY-2; FDA approval; clinical trial results
FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval
FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay
Boundless Bio Lays Off 33% of Staff Following Stumble of Lead Program
Boundless Bio; layoffs; biotech; clinical trial; BBI-355; BBI-825; RNR inhibitor; CHK1 inhibitor; combination therapy; solid tumors; pipeline restructuring
About 5% of CBER and CDER Left After FDA Staff Cuts, Analysis Finds
FDA layoffs; CBER; CDER; drug review; biologics; staff cuts; Trump administration; drug approval process
Sanofi Acquires Vigil Neuroscience for $470 Million, Bolstering Alzheimer’s Drug Pipeline
Sanofi; Vigil Neuroscience; acquisition; Alzheimer’s disease; TREM2 agonist; VG-3927; microglia; neurodegenerative disease; Phase 2 trials; biotech deals
FDA Advisory Committee Unanimously Votes Against Expanding Pfizer’s Prostate Cancer Drug Combo
FDA; advisory committee; Pfizer; Talzenna; talazoparib; enzalutamide; prostate cancer; mCRPC; PARP inhibitor; label expansion; unanimous vote
Incyte’s Zynyz Secures FDA Approval for Anal Cancer After Previous Rejection
Incyte; Zynyz; retifanlimab; FDA approval; anal cancer; PD-1 inhibitor; first-line therapy; immunotherapy; clinical trial; POD1UM-303; combination chemotherapy
GSK Acquires Phase III-Ready Liver Drug Efimosfermin for Up to $2B to Enter MASH Arena
GSK; Boston Pharmaceuticals; efimosfermin alfa; Phase III; liver disease; MASH; SLD; drug acquisition; FGF21 analog