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All of Us hits 1M participants — national diverse cohort complete
The NIH’s All of Us research program reached its recruitment goal of one million participants, delivering a cohort designed to reflect the diversity of the U.S. population. NIH reported the...
10x braces for modest growth — imaging‑free spatial tools advance
10x Genomics projected up to 4% revenue growth for 2026 and warned that constrained capital spending among customers will continue to pressure instrument revenue, while consumables demand —...
FDA declines to review Moderna flu shot — regulatory uncertainty ripples
The FDA declined to accept Moderna’s mRNA influenza vaccine for review, creating fresh regulatory uncertainty for mRNA platforms beyond COVID‑19 and prompting industry concern about shifting...
Gilead buys Genhouse cancer drug: $80M upfront for global rights
Gilead agreed to acquire global rights to an oral oncology candidate from China‑based Genhouse Bio for $80 million up front, a deal announced as Genhouse pursues a Hong Kong IPO. The transaction...
FDA rejects Disc’s bitopertin: Voucher-backed rare-disease bid fails
The FDA issued a rejection letter for Disc Medicine’s bitopertin, the company’s experimental therapy for porphyria, after questioning the link between the trial’s blood biomarker and meaningful...
PTC pulls Translarna: Two-decade Duchenne bid stalls
PTC Therapeutics announced it will not pursue FDA approval for Translarna (ataluren) in Duchenne muscular dystrophy after regulators signaled the submitted data were unlikely to meet the agency’s...
FDA balks at Moderna flu: Review refused – industry on edge
The FDA declined to accept Moderna’s application for its mRNA influenza vaccine, an unexpected regulatory rebuff that has rippled through biotech markets. STAT’s reporting captured industry...
NIAID shifts focus: 'Biodefense' and pandemic preparedness deprioritized
Internal communication obtained by Nature shows the National Institute of Allergy and Infectious Diseases (NIAID) has directed staff to remove references to 'biodefense' and 'pandemic...
Lyell launches head-to-head CAR‑T trial: First-of-its-kind test
Lyell Immunopharma opened a randomized, head-to-head CAR‑T trial that will pit its experimental product directly against marketed cell therapies. The trial is notable for testing a next-generation...
Australia launches first pediatric mRNA brain-cancer trial
Australia began the Paedneo‑Vax trial, the first multisite pediatric study testing individualized mRNA vaccines for aggressive childhood brain tumors. The trial is funded by Providence...
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...