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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....
Quantx raises $85M to advance oral immunology drugs into trials
Quantx Biosciences closed an oversubscribed $85 million Series B to accelerate two oral immunology candidates: a STAT6 small‑molecule inhibitor and an oral IL‑17 inhibitor. The company plans to...
Anterior grabs $40M — AI to speed payer approvals to minutes
Anterior raised $40 million to expand its AI platform that automates administrative clinical workflows for health plans, with the stated goal of compressing care‑approval cycles from weeks to...
Australia launches world‑first pediatric individualized mRNA brain‑cancer trial
Australia has launched Paedneo‑Vax, the first multisite pediatric trial testing individualized mRNA vaccines for aggressive childhood brain tumors. Funded by Providence Therapeutics, the...
Nektar, Evommune post positive Phase II readouts in atopic dermatitis
Nektar Therapeutics and Evommune reported positive Phase II results in atopic dermatitis, delivering data that supported upbeat investor reactions and subsequent financings covered in BioCentury’s...
FDA rejects Disc’s porphyria drug — biomarker link questioned
The FDA rejected Disc Medicine’s experimental porphyria therapy bitopertin, citing uncertainties about the blood-based biomarker used as the efficacy endpoint. The agency said the surrogate...
FDA refuse-to-file blindsides Moderna — flu program under scrutiny
The FDA issued a refuse-to-file letter for Moderna’s mRNA influenza vaccine, asserting concerns about trial design and the choice of comparator, and declined to proceed with a formal review....
Infigratinib phase III clears bar — BridgeBio adds oral option for achondroplasia
BridgeBio reported positive top-line results from its global phase III Propel 3 trial of oral infigratinib in children with achondroplasia, meeting growth and body-composition endpoints. The drug,...
All of Us reaches 1 million participants — diversity milestone for precision medicine
NIH’s All of Us research program has reached its target of collecting genetic and health-related data from one million Americans, the agency announced. The dataset aims to represent the country's...