Get the Daily Brief
Latest Biotech News
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,...
Personalis ctDNA MRD assay predicts immunotherapy response across solid tumors
A Phase I study published in Clinical Cancer Research demonstrated that Personalis’ NeXT Personal whole‑genome, tumor‑informed circulating tumor DNA (ctDNA) assay predicts early immunotherapy...
Harbour Biomed inks big antibody pact with Bristol Myers — $90M up front, $1B+ upside
Harbour Biomed closed a multiyear research and development deal with Bristol Myers Squibb centered on multispecific antibody programs, receiving roughly $90 million upfront with potential...
pTau217 blood test goes large — ALZpath study and Siemens licensing deal
ALZpath announced the first large‑scale study using a pTau217 blood assay (Simoa® ALZpath pTau217) to detect Alzheimer’s disease early and at population scale. The study represents a landmark...
Chai Discovery raises $130M to scale AI‑first antibody design
Chai Discovery closed a $130 million Series B to expand commercialization and R&D of Chai‑2, its generative AI platform for de novo antibody design. The company reported preprints showing...
FDA clears GSK’s twice‑yearly asthma drug – dosing cut to two injections a year
The FDA 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 follows positive SWIFT‑1 and...
ctDNA drop predicts checkpoint benefit – Personalis assay validated
A Phase I study published in Clinical Cancer Research demonstrates that Personalis’ NeXT Personal MRD assay—an individualized whole‑genome sequencing ctDNA test—accurately predicts immunotherapy...
Peanut patch passes pivotal trial – DBV to file BLA after Phase III win
DBV Technologies reported positive top‑line results from Vitesse, a pivotal Phase III trial of the Viaskin peanut epicutaneous immunotherapy patch in children aged 4–7. The trial met its primary...
FDA eases real‑world evidence rules – devices first, drugs next
The U.S. Food and Drug Administration announced a shift to less restrictive use of real‑world evidence (RWE) in regulatory submissions, starting with new device premarket guidance that relaxes the...
Addition Therapeutics emerges with $106M and an all‑RNA gene‑insertion platform
Addition Therapeutics surfaced from stealth with a sizeable financing and a novel RNA‑mediated insertion platform. The startup raised $106.5M to advance its PRINT (Precise RNA‑Mediated Insertion...
Chai Discovery nets $130M Series B – AI designs therapeutic antibodies
AI antibody designer Chai Discovery closed a $130M Series B to scale its Chai‑2 generative platform for de novo antibody and full‑length mAb design. Chai reported double‑digit experimental success...
Harbour Biomed inks big antibody deals – BMS pact tops $1B in milestones
Harbour Biomed closed a multiyear discovery and development collaboration with Bristol Myers Squibb for multispecific antibodies, receiving roughly $90M upfront and potential milestones exceeding...
FDA warning letter lands on Novo Nordisk over acquired Catalent plant – manufacturing in focus
The FDA issued a warning letter to Novo Nordisk concerning the Bloomington, Indiana manufacturing facility it acquired from Catalent last year. The agency is asking Novo Nordisk to perform...
Norgine secures Europe rights to Vir’s hepatitis D combo – regional license signed
Norgine signed an exclusive licensing agreement to commercialize Vir Biotechnology’s experimental chronic hepatitis D combination—tobevibart plus elebsiran—in Europe, Australia and New Zealand....
Valinor raises $13M seed to use multi‑omics and ML to improve trial design
AI biotech Valinor closed a $13M seed round to develop a multiomics‑powered machine learning platform designed to improve clinical trial design and patient selection. The San Francisco startup...