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Regulatory - peptide compounding expands after FDA panel votes
An FDA advisory panel narrowly recommended expanding compounding of certain unapproved peptides, including support for epitalon while rejecting compounding of emideltide, in tightly contested...
Regulatory - EU CHMP backs orphan drugs and rejects an FDA-approved therapy
The EMA’s CHMP backed two orphan drug orphan indications while issuing a negative opinion on a therapy already approved in the U.S., underscoring continued divergence between FDA and European...
Pipeline - Amgen fights FDA dispute for Tavneos with fresh analysis
Amgen submitted a new analysis to the FDA intended to support maintaining Tavneos (avacopan) on the market amid an ongoing regulatory dispute over the rare disease product. The company said the...
Clinical evidence - CAR-T genetic “red flags” tied to toxicity risk
A new genetic analysis of Kite Pharma’s Yescarta CAR-T trial cohorts identified patient DNA signatures linked to toxicity risk and pointed to specific mutations that may predict severe adverse...
Clinical evidence - Alzheimer’s biology gains clarity via 3D genome single-cell maps
A single-cell multiomics study connected genome 3D architecture changes to disrupted gene regulation in Alzheimer’s disease, offering a mechanistic layer beyond standard...
Drug development - Oral antiviral candidate blocks transmission in a ferret measles-like model
A preclinical study reported that the oral viral polymerase inhibitor GHP-88310 blocked contact-mediated and airborne transmission in a ferret model of measles-like disease. Published in Nature...
Corporate - CRISPR IPO push continues as Scribe raises about $129M
Scribe Therapeutics priced an upsized initial public offering to raise about $129 million, extending a strong biotech IPO run and giving the CRISPR-focused developer fresh funding for early...
Cell therapy innovation - iPSC-derived allogeneic γδ T cells suppress colorectal tumors preclinically
Kobe University researchers reported off-the-shelf iPSC-derived allogeneic gamma delta (γδ) T cells that suppressed colorectal cancer growth in mouse xenograft models, pointing to a more scalable...
CDMO deal - ABL Diagnostics to buy Texcell for €2.9M
ABL Diagnostics won French commercial court clearance to acquire Texcell in a €2.9 million deal, expanding its viral safety and bioassay service capabilities. The transaction covers payment for...
Med-tech/biotech - Medtronic expands chronic pain portfolio via Viaverte and SPR acquisition
Medtronic launched its Viaverte basivertebral nerve ablation system and completed the acquisition of SPR Therapeutics, broadening its chronic pain offering across the care continuum. The...
Regulatory and policy pressure on peptide compounding
An FDA advisory panel narrowly recommended broader use of certain unapproved peptides, setting up a politically charged decision on whether to expand compounding access. The votes followed...
Large-scale gene-editing trial death spotlights oversight gaps
A Science and Retraction Watch investigation revisited the fatal outcome of an experimental gene-editing intervention in China, where a 6-year-old girl died after receiving a brain-directed base...
CRISPR funding and IPO momentum returns
Scribe Therapeutics priced a roughly $129 million IPO, bringing a CRISPR-focused in vivo platform targeting cardiovascular and metabolic disease onto the Nasdaq under the ticker SCTX. The company...
Big drug and developer pivot: Sanofi abandons atopic dermatitis filings
Sanofi halted plans to seek approval of amlitelimab in atopic dermatitis, concluding the OX40-ligand antibody would not deliver meaningful improvement over existing standard of care. The move...
CAR-T toxicity biology points to patient DNA signatures
A new Science Immunology analysis of patients treated with Kite Pharma’s Yescarta (axi-cel) identified genetic signatures associated with toxicity risk. Led by Mark Leick of Massachusetts General...
New drug efficacy readouts: retatrutide edges toward BLA
Eli Lilly reported additional late-stage results for retatrutide, advancing its “triple-G” obesity program toward an FDA biologics license application. New Phase 3 data in trials spanning obesity...
Pipeline science: off-the-shelf iPSC-derived allogeneic T cells for solid tumors
Kobe University researchers reported preclinical efficacy for mass-produced iPSC-derived allogeneic gamma delta T cells in colorectal cancer. In mouse colorectal cancer xenograft models, the...
Translational platform: AI and software integration for biotech datasets
Pythia Biosciences and Lexogen announced a partnership to integrate Lexogen’s RNA sequencing services into Pythia’s Data Universe platform. The collaboration targets a common constraint in public...
Med-tech dealmaking and chronic pain expansion
Medtronic launched its Viaverte basivertebral nerve ablation system and completed the acquisition of SPR Therapeutics, extending its chronic pain offering across the pain care continuum. The...
Biomanufacturing and M&A: Samsung Biologics moves into peptide CDMO with PolyPeptide bid
Samsung Biologics proposed an all-cash tender offer of about $1.8 billion to acquire PolyPeptide Group, positioning the acquisition as a modality expansion into peptide therapeutics. The deal...