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Immutep trial halted for futility – stock collapses
Immutep disclosed that an independent data monitoring committee recommended stopping its Phase III TACTI-004 trial of eftilagimod alfa (efti) in first-line non-small-cell lung cancer for futility,...
FDA tentatively clears Lutathera generic – patent fight ahead
The FDA issued a tentative approval for Lantheus’ ANDA for PNT2003, a generic version of Novartis’ radioligand therapy Lutathera (lutetium Lu 177 dotatate), while Novartis continues active patent...
New HER2 ADC posts robust responses in urothelial cancer
Phase 2 data presented at ASCO Genitourinary show disitamab vedotin (DV), a HER2‑targeting antibody‑drug conjugate, produced confirmed overall response rates above 50% in both HER2‑positive and...
Cadonilimab combo improves outcomes in advanced cervical cancer
COMPASSION‑16 Phase 3 results indicate that adding cadonilimab, a bispecific PD‑1/CTLA‑4 inhibitor, to first‑line chemotherapy with or without bevacizumab improves clinical outcomes in advanced...
Ultragenyx gene therapy clears key Phase 3 bar for OTC deficiency
Ultragenyx announced that its gene therapy candidate for ornithine transcarbamylase (OTC) deficiency met one of two primary endpoints in a Phase 3 study enrolling 37 patients. The result...
Multi‑cytokine scaffold produces longer‑lived CAR‑T cells
Researchers at Albert Einstein College of Medicine reported a manufacturing strategy using an engineered protein scaffold (HCW9206) that fuses IL‑7, IL‑15 and IL‑21 to generate CAR‑T cells...
Genetic code expansion: five noncanonical amino acids in one protein
A synthetic biology group demonstrated simultaneous incorporation of five distinct noncanonical amino acids into a single protein in mammalian cells, significantly expanding the capability to...
AI plus autonomous lab cuts cycle time for biological discovery
OpenAI and Ginkgo Bioworks reported a collaboration showing how AI models integrated with an autonomous laboratory can design and iterate real biology experiments at substantially higher speed....
FDA drafts guidance to ease biosimilar testing — competition could accelerate
The FDA released draft guidance that would, in some cases, lower the data requirements for biosimilar development by allowing use of comparator product data from outside the U.S. The agency said...
Orphan drug market set to surge past $400B by 2032
Evaluate’s 2026 Orphan Drugs Report forecasts global orphan drug sales will exceed $400 billion by 2032, driven by high‑value gene and cell therapies, extended uses of existing orphan brands, and...
Immutep’s phase III shock: efti trial stopped for futility
Immutep’s Phase III TACTI-004 trial of eftilagimod alfa (efti) in first-line non‑small‑cell lung cancer was halted after an independent data monitoring committee recommended stopping for futility....
Ultragenyx gene therapy clears major Phase 3 endpoint in OTC deficiency
Ultragenyx reported that its gene therapy candidate met a key primary endpoint in a Phase 3 trial for ornithine transcarbamylase (OTC) deficiency, a rare urea cycle disorder. The company disclosed...
Lantheus wins tentative FDA ANDA for Lutathera rival amid patent war
The FDA issued tentative approval for Lantheus’ ANDA for PNT2003, an asserted generic equivalent to Novartis’ radioligand Lutathera (lutetium Lu 177 dotatate), even as Novartis pursues multiple...
GSK wins expanded FDA clearance for RSV vaccine Arexvy
GSK secured broader FDA clearance for its respiratory syncytial virus (RSV) vaccine Arexvy, expanding approved indications and potentially boosting uptake after an initially sluggish launch. The...
China approves first commercial brain‑computer implant for spinal injuries
China granted commercial approval to Neuracle Medical Technology’s invasive brain‑computer interface (BCI) for people with spinal cord injuries, the first national clearance worldwide for a BCI...
Genetic code expanded: five noncanonical amino acids incorporated in a single mammalian protein
Researchers reported a method enabling the simultaneous incorporation of up to five distinct noncanonical amino acids (ncAAs) into a single protein in mammalian cells—an advance that broadens the...
Src appears on tumor surface — antibody therapies get a new target
UCSF researchers discovered that Src kinase, historically considered an intracellular oncogenic driver, can be presented on the exterior membrane of tumor cells through an autophagolysosomal...
Trispecific macrophage engager enhances solid‑tumor killing
A logic‑gated trispecific engager designed to direct macrophages against solid tumor cells showed enhanced antitumor activity in preclinical models. Published in Nature Biotechnology, the work...
Amino acid supplement boosts LNP delivery for mRNA and CRISPR in vivo
A team at the Biohub reported that co‑administering a three‑amino‑acid cocktail with lipid nanoparticles (LNPs) markedly improved in vivo mRNA delivery and CRISPR editing efficiency in preclinical...
Bacterial strain breakthrough could unblock doxorubicin production bottleneck
An international consortium engineered a bacterial strain that overcomes decades‑old biosynthetic constraints in the production of doxorubicin, a cornerstone anthracycline chemotherapy. The...