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FDA approvals and PI3K-targeted breast cancer regimen
The FDA approved gedatolisib (Revtorpyk) with fulvestrant, with or without palbociclib, for adults with hormone receptor–positive, HER2-negative advanced breast cancer after progression on...
Oncology treatment sequencing in squamous cell carcinoma of the head and neck
A new randomized Phase II trial, OPTIM, is testing an escalation strategy in recurrent or metastatic squamous cell carcinoma of the head and neck, starting with nivolumab and moving to...
Immunotherapy timing appears to affect survival in advanced cancers
A new analysis in the British Journal of Cancer links the timing of immune checkpoint inhibitor dosing to overall survival in advanced cancer, according to results from a large, single-center...
GM-CSF-free alternative: RENAL RRI-guided blood pressure titration in sepsis
Researchers reported results from a randomized trial in Nature Communications evaluating whether renal resistive index (RRI)–guided mean arterial pressure (MAP) targets improve outcomes for...
New FDA-affecting CMS pricing pressure from midsize biotechs
Midsize biotech companies met with White House and HHS officials to urge changes to pending Centers for Medicare & Medicaid Services (CMS) pricing models, arguing the rules could hinder...
AI-designed gene-editing enzymes broaden CRISPR toolkit
A Science paper describes an AI-designed synthetic TnpB enzyme, SynTnpBs, designed to expand the range of programmable gene-editing options beyond natural references. Researchers report that the...
Venture funding for vaginal health startup Juno Bio
Juno Bio raised $3.8M to advance products in vaginal health, with support from Ada Ventures, Artesian, Entrepreneur First, and the Illumina Accelerator. The round signals continued investor...
Celcuity’s FDA approval met a near-term market reaction
Celcuity’s FDA approval of Revtorpyk for cancer was widely expected, but the stock reportedly dipped after the approval followed by a delayed launch timing into the end of the quarter. The market...
R&D and precision diagnostics: ctDNA-based selection for radium-223 therapy
A study in the July issue of The Journal of Nuclear Medicine reports that circulating tumor DNA (ctDNA) profiling could help select patients likely to benefit from radium-223 (^223Ra)...
Immunometabolic aging mechanism points to EP2 as a druggable target
A Science study from Stanford Medicine links organ aging to a failure of tissue-resident macrophages to clear senescent neutrophils, identifying EP2 signaling as a central regulator of this...
FDA action and market reaction to Celcuity’s Revtorpyk
FDA approved Celcuity’s cancer drug Revtorpyk, but trading signals undershot expectations as the product’s commercial launch timeline slipped into the end of the quarter. The approval was widely...
Regulatory setback and new Phase III attempt for Sarepta’s Elevidys in Europe
Sarepta moved to restart its path in Europe for Duchenne muscular dystrophy gene therapy Elevidys after the EMA declined marketing authorization following inadequate efficacy evidence. The company...
Commercial product failure: GSK halts camlipixant for refractory chronic cough
GSK is stopping work on camlipixant, a P2X3 receptor antagonist acquired from Bellus Health, after mixed Phase III results in adults with refractory chronic cough. Calm-1 met its primary endpoint...
Pancreatic cancer interception: mutant KRAS vaccine hits early clinical milestone
A Phase I trial of a mutant KRAS vaccine for pancreatic cancer prevention reached its first clinical milestone, producing KRAS-specific T-cell responses in 90% of participants in a high-risk...
Deep biology of aging: EP2 signaling in tissue-resident macrophages controls neutrophil clearance
Stanford Medicine researchers reported that organ aging is linked to impaired clearance of senescent neutrophils, driven by EP2 signaling in tissue-resident macrophages. In mice and human cells,...
Duchenne cardioprotection: USF study maps a heart-preserving strategy
A University of South Florida team reported a potential pathway to preserve heart function in Duchenne muscular dystrophy, with results published in Molecular Therapy. The study focused on cardiac...
Diagnostics expansion: Danaher’s Leica to buy Statlab
Leica Biosystems agreed to acquire Statlab Medical Products in a deal intended to broaden Danaher’s diagnostics and anatomical pathology footprint. While financial terms were not disclosed, RBC...
Advisory committee controversy: FDA credibility spotlight on peptides and RP1
BIOCENTURY reported that peptides-related and RP1 advisory committees could test FDA credibility after seven compounding panel members with ties to peptide businesses were identified, while the...
Funding: Braveheart Bio charts Nasdaq debut after Hengrui-licensed HCM asset
Braveheart Bio filed for and is progressing toward Nasdaq debut following a strategy built around BHB-1893, an oral cardiac myosin inhibitor for hypertrophic cardiomyopathy. The company’s asset...
Diagnostics innovation: blood ctDNA better selects prostate cancer patients for radium-223
A study in The Journal of Nuclear Medicine suggested that circulating tumor DNA profiling can improve patient selection for radium-223 (^223Ra) radiopharmaceutical therapy in metastatic...