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U.S. Supreme Court blocks IRA Medicare price negotiation challenges
The U.S. Supreme Court declined to take up multiple biopharma challenges to the Inflation Reduction Act’s Medicare drug price negotiation program, dealing another blow to brand manufacturers...
Oncology immunotherapy failure plus strategic dealmaking at Regeneron
Regeneron’s melanoma immunotherapy program stumbled in a late-stage test: the company said a fianlimab plus Libtayo regimen failed to improve outcomes versus Keytruda in a phase 3 setting, adding...
Cell and gene therapy trial operations in China with global data reuse
Dark Horse Consulting and KunTuo Research and Development announced a memorandum of understanding aimed at helping sponsors advance cell and gene therapy trials in China while enabling reuse of...
AI for clinical decision support in radiotherapy planning
An international trial led by University College London and the London School of Hygiene & Tropical Medicine reported that an AI system can improve radiotherapy planning for cervical and prostate...
Cancer detection and screening lift with cfDNA liquid biopsy
Delfi Diagnostics reported that its cell-free DNA liquid biopsy test, FirstLook Lung, increased lung cancer screening uptake by nearly threefold in a cluster-randomized interventional FIRSTLUNG...
Neurodevelopmental precision target discovery in Fragile X syndrome
UCLA Health researchers identified EPAC2 as a potential therapeutic target for Fragile X syndrome in preclinical work published in Neuron. The study, led by Carlos Portera-Cailliau and colleagues,...
Rare disease and neuroscience innovation via new CAR T in CD94-positive lymphomas
MD Anderson received FDA IND clearance to start a phase I trial of JV-394, a CD94-targeted CAR T therapy for patients with relapsed or refractory CD94-positive T/natural killer cell lymphomas. The...
China and dealmaking: early-stage risk shifts and licensing-driven growth
A JPMorgan analysis reported that biopharma licensing reached $82.7 billion in announced deal value in Q1 2026, while upfront cash represented only about 6% of total deal value—suggesting partners...
Clinical oncology: Merck’s TROP2 ADC posts endometrial survival win
Merck’s sacituzumab tirumotecan (sac-TMT) cleared a major late-stage hurdle in advanced endometrial cancer, becoming the first TROP2 antibody–drug conjugate to show an overall survival and...
Regulatory action: FDA approves AstraZeneca aldosterone synthase inhibitor for hypertension
The FDA approved AstraZeneca’s baxdrostat as Baxfendy, positioning it as the first drug in a new class of aldosterone synthase inhibitors for hypertension patients not adequately controlled on...
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...