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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...
Immutep’s LAG‑3 gamble fails: stock plunges after Phase III futility
Immutep disclosed that an independent data monitoring committee recommended stopping the Phase III TACTI‑004 study of eftilagimod alfa (efti) in first‑line non‑small‑cell lung cancer for futility....
Cadonilimab combo extends benefit in advanced cervical cancer – Phase III
COMPASSION‑16 Phase III results show cadonilimab combined with chemotherapy, with or without bevacizumab, improves outcomes as first‑line treatment for advanced cervical cancer, the sponsors...
Ultragenyx gene therapy clears key bar: late‑stage endpoint met in OTC study
Ultragenyx reported that its gene therapy candidate for ornithine transcarbamylase (OTC) deficiency met one of two primary endpoints in a Phase III trial, marking a pivotal clinical advance for a...
Sana cell therapy shows persistent insulin production: 14‑month follow‑up
Sana Biotechnology reported that an investigational allogeneic cell therapy continued producing insulin in a single Type 1 diabetes patient at 14‑month follow‑up with no new safety signals. The...
Senolytic strategy stalls pancreatic cancer’s growth in preclinical models – new avenue
Researchers reported that a senolytic therapeutic approach targeting senescent cells in the tumor microenvironment produced tumor control in preclinical pancreatic ductal adenocarcinoma (PDAC)...
Engineered bacteria break decades‑old doxorubicin bottleneck: scalable biosynthesis
An international team engineered a bacterial strain that overcomes long‑standing biosynthetic bottlenecks in doxorubicin production, the consortium reported in Nature Communications. The...
Src appears on tumor surfaces: antibody therapies gain a new target
UCSF scientists discovered extracellular membrane‑associated Src (eSrc) on the surface of multiple tumor types and demonstrated that antibodies targeting eSrc shrink tumors in mouse models, the...
Modular cytokine scaffold lengthens CAR‑T persistence – Science Advances
Researchers at Albert Einstein College of Medicine reported a manufacturing approach that uses a tricytokine fusion scaffold (IL‑7/IL‑15/IL‑21) to generate CAR‑T cells enriched for long‑lived T...
PSMA PET reduces need for prostate biopsies: PRIMARY2 shows diagnostic impact
The PRIMARY2 clinical trial demonstrated that PSMA PET/CT imaging can markedly lower the number of invasive prostate biopsies in men with suspected cancer after inconclusive or reassuring MRI, the...
FDA draft eases biosimilar testing: agency proposes lower barriers for approvals
The U.S. Food and Drug Administration issued draft guidance designed to simplify biosimilar development by allowing, in certain cases, reliance on comparator product data generated outside the...
Immutep’s LAG‑3 miss: Phase III stopped, stock tanks
Immutep disclosed that its Phase III TACTI‑004 trial of eftilagimod alfa (efti) in first‑line non‑small‑cell lung cancer was halted for futility after an independent data monitoring committee...
Ultragenyx hits co‑primary endpoint: gene therapy advances in urea‑cycle disease
Ultragenyx reported that its AAV‑based gene therapy achieved one of two co‑primary endpoints in a Phase III study for ornithine transcarbamylase (OTC) deficiency, a rare urea cycle disorder. The...