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All of Us hits 1 million: NIH dataset reaches diversity goal
The NIH’s All of Us research program reached its target of 1 million diverse participants, marking a major milestone for U.S. population‑scale precision-medicine infrastructure. NIH officials...
DNA origami vaccine induces broadly neutralizing HIV antibodies
Researchers at Scripps Research and MIT reported a DNA‑origami‑based vaccine scaffold that elicits broadly neutralizing HIV antibodies in preclinical models. The platform uses DNA nanostructures...
Engineered exosomes carry antibodies: targeted IBD delivery in preclinical models
A Nature Communications paper described engineered exosome nanovesicles that deliver therapeutic antibodies directly to inflamed gastrointestinal tissue, demonstrating targeted activity in...
Biotech financing roundup: Quantx $85M; Anterior $40M to scale AI approvals
Quantx Biosciences closed an $85 million Series B to advance two oral immunology programs—one targeting STAT6 and another IL‑17—into clinical testing, accelerating candidate IND timelines. The...
FDA rejects Disc’s porphyria drug: biomarker link questioned
The FDA formally rejected Disc Medicine’s application for bitopertin, citing uncertainty that the blood-based biomarker used in trials predicts clinical benefit for porphyria patients. The...
FDA refusal rattles Moderna — flu program and guidance clouded
The FDA refused to accept Moderna’s next‑generation mRNA influenza vaccine for review, a regulatory rebuke that the company says clouds its path to break‑even cash flow and forces a...
PTC withdraws Translarna US bid — data won’t meet FDA threshold
PTC Therapeutics withdrew its U.S. filing for Translarna (ataluren) after the FDA signaled the submitted data were unlikely to meet the agency’s threshold for substantial evidence of effectiveness...
Australia launches first pediatric mRNA brain‑cancer trial
Australia opened Paedneo‑Vax, the world’s first multisite pediatric trial testing individualized mRNA cancer vaccines for aggressive childhood brain tumors. Funded by Providence Therapeutics, the...
Lyell opens first‑of‑its‑kind CAR‑T head‑to‑head study
Cell therapy company Lyell Immunopharma initiated a clinical trial that will directly compare its experimental CAR‑T product against marketed CAR‑T therapies, a trial design intended to benchmark...
Gilead buys Genhouse oral cancer drug for $80M up front
Gilead acquired global rights to an oral oncology candidate from China‑based Genhouse Bio, paying $80 million up front. The deal gives Gilead an additional small‑molecule option in its cancer...
Quantx raises $85M to advance oral immunology programs
Quantx Biosciences closed an $85 million Series B to fund IND‑enabling work and human trials for its oral STAT6 and IL‑17 inhibitors. The oversubscribed round will support the company’s push into...
Anterior nets $40M to automate care approvals with AI
Anterior raised $40 million to expand an AI platform that automates administrative clinical review for health plans, enabling near‑real‑time prior authorization and care approvals. The company...
All of Us reaches 1M participants: dataset now representative
The NIH All of Us Research Program announced it achieved its target of 1 million participants, meeting goals to represent the nation’s diversity in genetics and health data. The expanded cohort...
NIAID told to downplay pandemic preparedness: staff ordered to scrub pages
Staff at the U.S. National Institute of Allergy and Infectious Diseases were reportedly instructed to remove references to 'biodefense' and 'pandemic preparedness' from public web pages amid an...
FDA rejects Disc’s porphyria drug: biomarker link questioned
The FDA has refused approval for Disc Medicine’s bitopertin, rejecting the company’s rare‑disease submission over uncertainties that the blood biomarker used as the trial’s efficacy endpoint...
FDA refuses to file Moderna’s flu shot — company says it was blindsided
The FDA issued a refusal‑to‑file for Moderna’s next‑generation mRNA influenza vaccine, prompting sharp pushback from company leaders who say the agency had previously signaled willingness to...
Lyell launches head‑to‑head CAR‑T trial versus marketed therapies
Lyell Immunopharma has opened a first‑of‑its‑kind CAR‑T clinical trial that will test its experimental cell therapy directly against marketed CAR‑T products. The randomized, comparative design...
Vertex’s CRISPR therapy rebounds — Casgevy sales surge
Vertex reported a sharp uptick in sales of Casgevy, its CRISPR‑based, gene‑edited therapy developed with CRISPR Therapeutics, driving a notable improvement in the company’s recent earnings...
Exact Sciences posts 23% Q4 revenue gain — Abbott acquisition heads to vote
Exact Sciences reported fourth‑quarter revenue of $878.4 million, a 23% year‑over‑year increase driven by growth in its cancer‑screening business and precision oncology testing. CEO Kevin Conroy...
BridgeBio’s oral infigratinib matches Voxzogo on height — adds pill option
BridgeBio reported data showing its oral FGFR3 inhibitor infigratinib matched the height outcomes achieved by Voxzogo (vosoritide) in achondroplasia patients, while offering an oral dosing option....