Get the Daily Brief
Latest Biotech News
FDA formalizes one pivotal‑trial default — policy shift in NEJM perspective
Top FDA officials published a New England Journal of Medicine perspective declaring that a single well‑controlled trial will be the regulator’s new default for drug approvals, replacing the...
Grail’s Galleri falls short: UK study misses primary endpoint
Grail reported that its multi‑cancer blood test showed encouraging signals but did not meet the primary endpoint in a major UK study carried out with the National Health Service, sending the...
Element unveils Vitari sequencer — 30× genome for about $100
Element Biosciences introduced Vitari, a high‑throughput sequencing platform that the company says delivers roughly 3 terabytes of data per paired‑end 150 bp run in 36 hours and can sequence a 30×...
Merck taps Mayo Clinic data and AI to accelerate target discovery
Merck struck a collaboration with Mayo Clinic to combine Mayo’s clinical and genomic datasets and analytic tools with Merck’s AI‑enabled virtual cell technologies to accelerate drug discovery...
Lilly pays $100M for CSL’s IL‑6 antibody rights — deal splits indications
Eli Lilly paid CSL $100 million upfront to license rights to clazakizumab, an IL‑6 monoclonal antibody, in indications outside CSL’s retained program. CSL will keep rights for a Phase 3 program...
Altesa raises $75M to reposition vapendavir for COPD exacerbations
Altesa BioSciences closed a $75 million Series B, led by Forbion with participation from Sanofi and others, to fund a Phase 2b trial of vapendavir — an oral antiviral that blocks rhinovirus entry...
Stanford’s intranasal vaccine protects mice against viruses, bacteria and allergens
Stanford researchers, led by Bali Pulendran, reported a preclinical intranasal vaccine that elicited broad mucosal protection in mice against multiple respiratory viruses (including SARS‑CoV‑2),...
FDA pivots to one pivotal trial — NEJM authors formalize new default
FDA Commissioner Marty Makary and CBER Director Vinay Prasad published a New England Journal of Medicine perspective formalizing a new regulatory default: one well‑controlled pivotal trial can...
FDA reverses course on Moderna flu shot — agency accepts revised filing
The FDA reversed an earlier refusal and agreed to review Moderna’s mRNA seasonal influenza vaccine mRNA‑1010 after a Type A meeting, assigning a target action date of Aug. 5. The agency will...
Novartis inks up‑to‑$1.8B macrocycle pact — Unnatural Products deal
Novartis began a research-and-license collaboration with Unnatural Products to apply UNP’s AI‑guided macrocyclic peptide platform to cardiovascular targets, with total deal value up to $1.8...
Korsana raises $175M — new Alzheimer’s antibody startup emerges
Korsana Biosciences launched with $175 million in venture backing to develop KRSA‑028, an amyloid‑targeting monoclonal antibody engineered to penetrate the blood‑brain barrier. Investors include...
Grail’s Galleri misses primary goal in UK study — shares plunge
Grail reported that its multi‑cancer blood test showed promising signals but failed to meet the primary endpoint in a large UK study conducted with the NHS. The company noted some encouraging...
Stanford unveils nasal 'universal' vaccine — broad lung protection in mice
Stanford Medicine researchers, led by Bali Pulendran, published preclinical data in Science describing an intranasal vaccine that protected mice from diverse respiratory viruses, bacteria and...
M‑PACT: methylation classifier identifies pediatric brain tumors from CSF
An international team led by St. Jude’s Children’s Research Hospital and Heidelberg’s Hopp Children’s Cancer Center reported M‑PACT, a methylation‑based predictive algorithm that classifies...
Electronic mesh implants drive islet maturation — 'cyborg' pancreatic organoids
Researchers at the Perelman School of Medicine (Penn) and Harvard reported in Science that an ultrathin, flexible electronic mesh implanted into developing pancreatic organoids recorded...
Plasma p‑tau217 ‘clocks’ forecast Alzheimer’s symptom onset within 3–4 years
Washington University researchers developed clock models based on plasma p‑tau217 to estimate the timing of symptomatic Alzheimer’s disease onset with a margin of error of roughly three to four...
Element unveils Vitari sequencer — 3Tb runs, $100 30X genome claim
Element Biosciences launched Vitari, its first high‑throughput sequencing platform, promising up to 3 terabytes per paired‑end 150 bp run in 36 hours and the ability to sequence a 30X human genome...
Novartis bets $1.8B on macrocycles: Unnatural Products deal
Novartis signed a multi-element discovery and licensing collaboration with Unnatural Products (UNP) to apply UNP’s AI‑guided macrocyclic peptide platform to cardiovascular targets. The agreement...
FDA pivots: single pivotal trial becomes new default
Top FDA officials authored a New England Journal of Medicine perspective establishing a single well‑controlled clinical trial as the agency’s new default for approvals, while urging sponsors to...
FDA reverses: will review Moderna’s mRNA flu shot
The FDA reversed a prior refusal and agreed to review Moderna’s mRNA seasonal influenza vaccine mRNA‑1010, assigning a PDUFA date of Aug. 5, 2026. Regulators and Moderna negotiated an amended...