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Liver mRNA reprogramming restores aged T cells — transient fix
Two independent reports show transient hepatic expression of key trophic factors via mRNA delivery can rejuvenate aged T cell populations and enhance vaccine and cancer immunotherapy responses in...
Personalis’ ctDNA MRD test predicts immunotherapy response across tumors
A Phase I study published in Clinical Cancer Research found that Personalis’ tumor‑informed whole‑genome ctDNA assay (NeXT Personal) predicts immunotherapy outcomes across metastatic solid tumors....
FDA eases RWE rules: devices first, drugs to follow
The U.S. Food and Drug Administration signaled a less restrictive stance on real‑world evidence (RWE) by issuing guidance that premarket device applications need not include identifiable...
Moderna taps CEPI to prop up H5 pandemic‑flu Phase 3
Moderna secured backing from the Coalition for Epidemic Preparedness Innovations (CEPI) to underwrite its Phase 3 study of an H5 pandemic influenza vaccine after U.S. government support was...
FDA clears GSK twice‑yearly asthma shot — Exdensur approved
The U.S. Food and Drug Administration approved GSK’s depemokimab (brand name Exdensur) as an add‑on maintenance therapy for patients aged 12 and older with severe eosinophilic asthma. The approval...
Peanut patch wins pivotal test: DBV plans U.S. filing after Phase III
DBV Technologies reported positive top‑line results from its pivotal Phase III Vitesse trial of the Viaskin peanut patch in children aged 4–7. The trial met its primary endpoint: 46.6% of treated...
Addition emerges from stealth — $106M for RNA ‘jumping‑gene’ therapies
Addition Therapeutics announced a $106.5 million financing and detailed its Precise RNA‑Mediated Insertion of Transgenes (PRINT) platform, an all‑RNA, lipid nanoparticle‑based approach to insert...
Orum pockets $100M — antibody‑degrader conjugates target AML
Orum Therapeutics closed about $100 million to advance a pipeline that fuses antibody targeting with protein‑degrader payloads. The company is pivoting toward ORM‑1153, a CD123‑targeting...
Chai Discovery raises $130M to scale AI antibody design
Chai Discovery closed a $130 million Series B to commercialize Chai‑2, its generative AI platform for de novo antibody design. The company published preprints showing multi‑target successes and...
Harbour Biomed inks BMS pact — up to $1.1B for multispecific antibody programs
Harbour Biomed signed a multiyear collaboration with Bristol Myers Squibb that includes roughly $90 million up front and potential milestones exceeding $1 billion to discover and develop...
ctDNA dynamics predict immunotherapy response; lymph fluid shows MRD promise
Two separate studies strengthened circulating‑tumor‑DNA (ctDNA) as a clinical biomarker. A Phase I study using Personalis’ NeXT Personal MRD assay found that early declines in tumor‑informed ctDNA...
FDA signals looser standards for real‑world evidence in reviews
The FDA announced a policy shift Dec. 15 to ease requirements for real‑world evidence (RWE) used in device premarket applications — specifically, the agency will not require identifiable...
CDC pivots on hepatitis B birth dose — universal guidance replaced with individualized approach
The U.S. Centers for Disease Control and Prevention adopted new Advisory Committee on Immunization Practices recommendations that end the universal hepatitis B birth‑dose policy that had been in...
Link Cell raises $60M — J&J backs CAR‑T spinout focused on solid tumors
Link Cell Therapies launched with a $60 million Series A to develop next‑generation CAR‑T therapeutics against solid tumors and announced strategic backing tied to Johnson & Johnson. The startup...
FDA clears GSK’s twice‑yearly asthma drug — dosing shift for biologics
The FDA approved GSK’s depemokimab (brand name Exdensur) as an add‑on maintenance therapy for patients 12 and older with severe eosinophilic asthma. The approval, built on the SWIFT‑1 and SWIFT‑2...
Peanut patch rebounds — DBV’s Viaskin posts pivotal Phase 3 win
DBV Technologies reported positive top‑line results from the pivotal Vitesse Phase 3 trial of its Viaskin peanut patch in children aged 4–7, meeting the trial’s primary endpoint. The trial...
Addition emerges with PRINT: all‑RNA LNP gene insertion platform
Addition Therapeutics unveiled its Precise RNA‑Mediated Insertion of Transgenes (PRINT) platform, an all‑RNA, lipid‑nanoparticle (LNP) approach to genomic insertion based on retrotransposon...
Orum banks ₩146bn (~$100M) to advance degrader‑antibody conjugates
Orum Therapeutics closed a financing of roughly 146 billion Korean won (about $100 million) to advance a pipeline that merges antibody targeting with protein‑degrader payloads. The company plans...
FDA signals looser rules for real‑world evidence — device and drug paths open
The U.S. FDA announced a policy shift reducing constraints on the use of real‑world evidence (RWE) in regulatory submissions, starting with new device premarket guidance that will accept...
CDC ends universal hepatitis B birth‑dose guidance — adopts individualized schedule
The U.S. Centers for Disease Control and Prevention adopted new ACIP recommendations that remove the longstanding universal hepatitis B birth‑dose guidance, shifting to an individualized,...