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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...
GSK wins FDA nod – twice‑yearly asthma biologic
The FDA cleared GSK’s depemokimab (Exdensur) as an add‑on maintenance therapy for patients aged 12 and older with severe eosinophilic asthma. The agency’s approval follows positive SWIFT‑1 and...
DBV rebounds: Viaskin patch clears Phase III in kids
DBV Technologies reported that its Viaskin peanut allergy patch met the primary endpoint in the pivotal Vitesse Phase III trial in children aged 4–7, with 46.6% responders on active treatment...
Personalis MRD assay flags immunotherapy responders – study
A multicenter study published in Clinical Cancer Research shows Personalis’ NeXT Personal whole‑genome, tumor‑informed MRD assay predicted early immunotherapy responses and survival across...
Addition emerges with PRINT tech — deep pockets follow
Addition Therapeutics unveiled its PRINT gene‑insertion platform after emerging from stealth with major backing and a plan to develop insertional gene therapies for chronic and rare disease. The...
BMS bets on Harbour’s antibody engine – big upfront, big upside
Bristol Myers Squibb struck a multiyear collaboration with Harbour BioMed aimed at multispecific antibody discovery and development, a deal that includes about $90 million up front and could...
Yarrow/RTW grabs China antibody for autoimmune thyroid disease
RTW‑backed Yarrow Bioscience licensed ex‑China rights to GS‑098, a thyroid‑stimulating hormone receptor (TSHR) antibody developed by Shanghai Scizeng/GenSci, in a deal that could reach $1.37...