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Thermo Fisher, Datavant partner to link RWD across 80,000 sites
Thermo Fisher Scientific’s PPD clinical research unit struck a strategic partnership with Datavant to enable privacy‑preserving linkage of real‑world data across more than 350 RWD partners and...
PacBio posts Q4 beat; consumables record and SPRQ‑Nx planned
Pacific Biosciences reported Q4 revenue of $44.6 million, up 14% year‑over‑year, driven by record consumables sales and growth in clinical market adoption. PacBio shipped 21 Revio instruments and...
Microbiotica’s oral live biotic induces remission in UC phase Ib – 12 of 19 patients
Microbiotica announced positive Phase Ib results for MB‑310, an orally administered live biotherapeutic for ulcerative colitis. In the randomized study, 12 of 19 treated patients achieved clinical...
Ribbon launches cell‑free long‑DNA program – early access for therapeutic makers
Ribbon Bio rolled out an early‑access program for a cell‑free version of its MiroSynth long‑DNA platform, offering synthetic linear DNA molecules up to ~11 kb with reported accuracy above 90% and...
FDA refuses to review Moderna flu vaccine — rare refusal-to-file
The FDA issued a refusal-to-file (RTF) letter for Moderna’s mRNA seasonal influenza application, stopping formal review of mRNA-1010 despite no direct safety or efficacy findings cited in the...
FDA’s vaccines chief overrules staff — regulators tighten vaccine gatekeeping
Internal dissent at the FDA surfaced after agency leadership, led by Vinay Prasad, overruled vaccine-review teams on Moderna’s submission—actions that industry sources say changed the outcome of a...
BridgeBio’s infigratinib clears Phase 3 — approval path on deck
BridgeBio reported positive top-line results from the global Phase 3 Propel 3 trial of oral infigratinib in children with achondroplasia, meeting the primary endpoint of increased annualized...
Madrigal inks $60M Ribo deal — siRNAs added to MASH arsenal
Madrigal Pharmaceuticals signed an exclusive licensing agreement with Suzhou Ribo Life Science and Ribocure for six preclinical siRNA programs targeting metabolic dysfunction-associated...
CareDx plans AlloHeme launch — assay spots relapse with 41-day lead
CareDx disclosed validation results for AlloHeme, its allogeneic hematopoietic cell transplant (HCT) surveillance cfDNA assay, from the observational ACROBAT study: sensitivity 85%, specificity...
PacBio posts revenue beat; long‑read push gains clinical traction
Pacific Biosciences reported Q4 revenue of $44.6 million, a 14% year‑over‑year increase that beat Street estimates, and full‑year 2025 revenue of $160.0 million. The company flagged record...
Ribbon opens early access to cell‑free long‑DNA — GMP‑friendly supply for CGT
Ribbon Bio launched an early‑access program for its cell‑free manufacturing of long synthetic DNA, offering linear molecules up to ~11 kb with reported accuracy above 90% and average ~95% for...
Thermo Fisher links PPD to Datavant — real‑world data linkage expanded
Thermo Fisher Scientific’s PPD clinical research unit struck a strategic partnership with Datavant to enable privacy-preserving tokenized linkage of de‑identified research datasets with real‑world...
Quantx raises $85M to start trials — oral STAT6 and IL‑17 programs
Quantx Biosciences closed an oversubscribed $85 million Series B to advance two oral immunology programs into the clinic: a STAT6 small‑molecule inhibitor and an IL‑17 oral inhibitor. The company...
Microbiotica’s live microbiome shows phase Ib remission signal in UC
Microbiotica reported positive Phase Ib data for MB‑310, an oral live biotherapeutic for ulcerative colitis: 12 of 19 treated patients achieved clinical remission versus 3 of 10 on placebo, with...
FDA refuses to review Moderna flu shot — agency cites trial design
The U.S. Food and Drug Administration issued a rare refusal-to-file for Moderna’s mRNA influenza vaccine (mRNA-1010), citing deficiencies in the pivotal trial’s comparator and overall study...
BridgeBio's oral dwarfism drug clears pivotal test — FDA filing planned
BridgeBio reported positive top-line results from Propel 3, a global Phase 3 trial of oral infigratinib in children with achondroplasia, meeting the primary endpoint for annualized height velocity...
Madrigal bets big on siRNA — $60M upfront, $4.4B potential deal with Ribo
Madrigal Pharmaceuticals struck a licensing and development agreement with Suzhou Ribo Life Science (Ribocure) to license six preclinical siRNA programs targeting metabolic dysfunction-associated...
CareDx’s AlloHeme flags relapse weeks early — high sensitivity and specificity
CareDx presented validation data from the observational ACROBAT study showing its AlloHeme cell‑free DNA assay for allogeneic hematopoietic cell transplant (HCT) surveillance achieved 85%...
Seres pauses lead program and trims workforce — microbiome strategy shifts
Microbiome specialist Seres Therapeutics announced a strategic reboot that pauses its flagship program and cuts about 30% of staff, refocusing resources toward earlier-stage immunology research....
Ribbon Bio launches cell‑free long‑DNA service — clinics and gene therapy makers targeted
Ribbon Bio opened an early‑access program for its new cell‑free long DNA manufacturing process, offering linear constructs up to ~11 kb with reported average accuracy near 95% and guaranteed...