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Dealmaking & platform buildout: Regeneron buys Parabilis stake in Helicon tie-up
Regeneron entered a multi-target Helicon partnership with Parabilis Medicines, taking an initial stake and committing $125 million up front with up to about $2.2 billion in additional milestones...
Diagnostics / lung screening: Delfi cfDNA test boosts screening uptake
Delfi Diagnostics reported that its cfDNA-based FirstLook Lung liquid biopsy assay drove roughly a three-fold increase in lung cancer screening rates in a cluster-randomized interventional...
Immuno-oncology: T-cell exhaustion reversal improves myeloma immunotherapies
Researchers from the Icahn School of Medicine at Mount Sinai, Bristol Myers Squibb, and the University of Oxford reported an approach to rejuvenate exhausted T cells and improve outcomes for...
Oncology biomarkers / monitoring: ctDNA guides outcomes in EXTEND trial
MD Anderson researchers reported Phase 2 EXTEND trial findings showing that circulating tumor DNA (ctDNA) testing can improve treatment monitoring in patients receiving metastasis-directed therapy...
Cell therapy: FDA IND clearance enables CD94-targeted CAR T phase I
The University of Texas MD Anderson received IND clearance from the FDA to start a Phase I trial of JV-394, a CD94-targeted CAR T-cell therapy for relapsed or refractory CD94-positive T/NK-cell...
Biotech financing: Violet Therapeutics raises $4.8M seed extension
Violet Therapeutics secured a $4.8 million seed extension to advance its RABID-seq platform, which combines barcoded viral tracing with single-cell RNA sequencing to map interactions between brain...
Regulatory & legal: Supreme Court declines IRA Medicare price negotiation challenges
The U.S. Supreme Court declined to take up lawsuits challenging Medicare prescription drug price negotiations under the Inflation Reduction Act, including petitions tied to AstraZeneca and...
CRO / trial execution: Dark Horse partners with KunTuo for China cell & gene therapy trials and data reuse
Dark Horse Consulting signed an MOU with Beijing-based CRO KunTuo Research and Development to help sponsors run cell and gene therapy trials in China while enabling reuse of data for future...
Oncology immunotherapy failure and dealmaking
Regeneron’s LAG-3 inhibitor fianlimab missed a key efficacy mark in a late-stage melanoma study, failing to beat Keytruda (pembrolizumab) by a statistically significant margin and adding to...
Regulatory pricing: Supreme Court keeps Medicare negotiation intact
The U.S. Supreme Court declined to hear multiple challenges to the Inflation Reduction Act’s (IRA) Medicare prescription drug price negotiation program, including cases brought by major biopharma...
Hypertension drug approval in a new class
The FDA approved AstraZeneca’s baxdrostat (branded Baxfendy), marking the first authorization in a new aldosterone synthase inhibitor class for certain patients with hypertension. AstraZeneca said...
Biopharma funding signals: De-risked deal structures and shifting capital
JPMorgan reported that biopharma dealmaking surged in Q1 2026 even as early-stage venture funding stayed under pressure, with licensing activity carrying a large share of announced value. The...
New translational platform for cell and gene therapy trials in China
Dark Horse Consulting and Beijing-based KunTuo Research and Development announced a memorandum of understanding to streamline cell and gene therapy trial execution in China. The agreement is...
Clinical biomarkers and liquid biopsy to improve screening uptake
Delfi Diagnostics reported clinical utility data for its cfDNA-based FirstLook Lung liquid biopsy assay, showing increased lung cancer screening participation in a cluster-randomized...
Cell therapy innovation: IND clearance for CD94-targeted CAR T
MD Anderson received FDA IND clearance to begin a Phase I trial of JV-394, a CD94-targeted CAR T-cell therapy for patients with relapsed or refractory CD94-positive T/natural killer (NK) cell...
Oncology translational tech: CTC platform adoption for exercise-outcome studies
CelLBxHealth said AdventHealth will use its CelLBxHealth Parsortix circulating tumor cell (CTC) platform in two cancer studies evaluating whether exercise can improve patient outcomes. The ACTION...
Regulatory science: BIO comments on Plausible Mechanism Framework
The Biotechnology Innovation Organization (BIO) submitted written comments supporting the FDA’s proposed “Plausible Mechanism Framework” for individualized or disease-targeted therapies when...
Biotech startup funding: Violet Therapeutics seed extension for RABID-seq mapping
Violet Therapeutics raised $4.8 million in a seed extension financing to advance its RABID-seq platform, which combines barcoded viral tracing with single-cell RNA sequencing to study interactions...
Regulatory – Medicare drug pricing legal fight ends
The U.S. Supreme Court declined to hear multiple biopharma challenges to the Inflation Reduction Act’s Medicare drug price negotiation program, dealing another blow to the brand-drug industry’s...
FDA approval – First-in-class aldosterone synthase inhibitor expands hypertension options
The FDA approved AstraZeneca’s Baxfendy (baxdrostat), a first-in-class aldosterone synthase inhibitor intended for patients with hypertension not adequately controlled on other therapies. FDA...