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German court blocks Merck’s subcutaneous Keytruda — Halozyme gains legal edge
A German court has ordered a halt to the sale of Merck’s subcutaneous formulation of Keytruda after ruling in favor of Halozyme in a broader patent dispute. The decision stops commercial...
Encoded links Dravet program to pivotal trial — ETX101 posts 78% seizure drop
Encoded Therapeutics reported phase 1/2 data for its Dravet syndrome gene therapy ETX101 showing a 78% reduction in seizures, a result the company said supports its plan to launch a pivotal study...
ACIP scraps universal hepatitis B birth dose: parents to consult with clinicians
An Advisory Committee on Immunization Practices (ACIP) vote shifted U.S. guidance away from a universal hepatitis B birth dose for newborns whose mothers test negative. The panel voted 8–3 to...
Freenome to public markets via $330M SPAC... PIPE backs commercialization plans
Bay Area liquid‑biopsy developer Freenome agreed to go public through a $330 million SPAC merger with Perceptive Capital Solutions Corp., backed by a roughly $240 million PIPE from investors...
Natera buys Foresight for $275M — folds phased‑variant MRD into Signatera
Natera agreed to acquire Foresight Diagnostics for $275 million upfront plus up to $175 million in contingent payments to integrate Foresight’s PhaseED‑Seq phased‑variant ctDNA technology into...
MRD shows promise as surrogate endpoint in AML trials — ASH dataset suggests predictiveness
Researchers presenting at the American Society of Hematology reported pooled prospective data indicating that minimal residual disease (MRD)‑negative status before consolidation treatment...
Vertex’s CRISPR therapy hits early milestone in children — label expansion in play
Vertex reported that Casgevy (exa‑cel), its CRISPR‑based gene editing therapy, met an early clinical goal in pediatric patients with sickle cell disease and transfusion‑dependent beta‑thalassemia....
Bristol Myers wins expanded Breyanzi label: marginal zone lymphoma added
Bristol Myers Squibb announced FDA approval to expand Breyanzi’s (lisocabtagene maraleucel) indication to include third‑line marginal zone lymphoma, making it the first CAR‑T therapy cleared for...
Praxis halts pivotal epilepsy study early for efficacy — stock jumps
Praxis Precision Medicines stopped its pivotal EMBOLD Phase 2/3 study of relutrigine in developmental and epileptic encephalopathies early after an interim analysis showed robust efficacy....
Encoded links ETX101 to 78% seizure reduction — pivotal Dravet trial planned
Encoded Therapeutics tied its ETX101 gene therapy for Dravet syndrome to a 78% reduction in seizures in Phase 1/2 data and signaled readiness to move into a pivotal study next year. The company...
Ginkgo wins $47M DOE contract to automate phenotyping at PNNL
Ginkgo Bioworks secured a four‑year, $47 million contract to design, build, and integrate an automated microbial phenotyping platform for Pacific Northwest National Laboratory’s Environmental...
Paradigm buys Flatiron’s clinical research arm: trials embedded into OncoEMR
Paradigm Health acquired Flatiron Health’s clinical research business and entered a multiyear collaboration to integrate Paradigm’s trial‑support infrastructure into Flatiron’s OncoEMR oncology...
ACIP scraps universal Hep B birth dose — newborn schedule shifted
A federal vaccine advisory panel voted to remove the longstanding recommendation that all newborns receive the hepatitis B vaccine within hours of birth. The Advisory Committee on Immunization...
FDA churn intensifies — Pazdur exits, Høeg named acting CDER chief
The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) saw another leadership shift as longtime oncology regulator Peter (Pat) Pazdur resigned and Tracy Beth Høeg...
Freenome heads for public markets — $330M SPAC deal clears path to 2026 launch
Bay Area cancer-detection developer Freenome agreed to go public via a $330 million SPAC merger, securing roughly $240 million in committed PIPE financing from healthcare investors such as...
Vertex’s Casgevy shows promise in kids — pediatric label expansion in view
Vertex Pharmaceuticals reported early data showing its CRISPR-based gene-editing therapy Casgevy achieved key efficacy goals in children with sickle cell disease and transfusion-dependent...
Praxis halts trial early — relutrigine posts strong efficacy in rare epilepsy
Praxis Precision Medicines stopped its Phase 2/3 EMBOLD study early after an interim analysis showed significant efficacy of relutrigine, a sodium-channel modulator for developmental and epileptic...
Bristol Myers expands Breyanzi use — first CAR-T approved for marginal zone lymphoma
Bristol Myers Squibb announced U.S. approval expanding its CAR-T therapy Breyanzi to include third-line treatment for marginal zone lymphoma, a rare indolent non-Hodgkin lymphoma. The approval...
Ginkgo wins $47M DOE contract — automating phenotyping at PNNL
Ginkgo Bioworks secured a four-year, $47 million contract to design and integrate an automated phenotyping platform for Pacific Northwest National Laboratory (PNNL). The scope covers automation of...
Natera buys Foresight — $275M upfront to bolster MRD and lymphoma reach
Natera agreed to acquire Foresight Diagnostics for $275 million upfront plus up to $175 million in milestone earnouts to integrate Foresight’s PhasED-Seq phased-variant ctDNA technology into...