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Regulatory decisions on compounding unapproved peptides
An FDA advisory panel moved to expand access to several unapproved peptides, in a politically charged vote that health secretary Robert F. Kennedy Jr. has linked to increased availability of...
Sanofi pivots away from amlitelimab in atopic dermatitis
Sanofi said it will stop seeking approval for amlitelimab in atopic dermatitis, citing that the OX40-ligand antibody would not meaningfully improve care for patients with moderate to severe...
EU CHMP endorses orphan drug Minoryx; rejects Zevra’s NPC therapy
The EMA’s CHMP issued positive opinions for two orphan drugs, including Minoryx’s cALD therapy after a prior rejection, while also delivering a setback to Zevra Therapeutics. CHMP backed Minoryx’s...
New evidence sharpens CAR-T safety genetics in Yescarta (axi-cel)
A new analysis of patients treated with Kite’s Yescarta (axi-cel) identified genetic signatures linked to toxicity risk, published in Science Immunology. Researchers led by Mark Leick at...
Biotech IPO window stays hot as Scribe prices $129M
Scribe Therapeutics priced an upsized CRISPR-focused IPO, raising about $129 million gross as it begins trading on Nasdaq under ticker SCTX. The company’s initial clinical strategy centers on in...
Oral antiviral candidate blocks measles-like transmission in ferrets
Researchers reported in Nature Microbiology that the oral viral polymerase inhibitor GHP-88310 blocked both contact-mediated and airborne transmission of a measles-like virus in ferrets. The work,...
Biopharma funding: Transcripta raises $24M for neuro pipeline
Transcripta Bio raised $24 million since its Series A to advance IND-enabling work across its neuro pipeline. The funding supports clinical preparation in autism spectrum disorder and...
Deal and platform moves: Dassault to buy Arisglobal up to $2B
Dassault Systèmes agreed to acquire Arisglobal for up to $2 billion, strengthening its life sciences software strategy. The deal combines Arisglobal’s AI-enabled safety and regulatory intelligence...
Gene regulation science: NIH 4D Nucleome expands multi-omics maps
NIH’s 4D Nucleome program delivered new single-cell multi-omics insights across health and disease, with eight papers published across Science and Science Advances on July 23. The studies connect...
Cardiovascular royalty deal targets ATTR-CM amyloid depleter cliramitug
Royalty Pharma agreed to invest in Neurimmune’s cliramitug, paying $125 million upfront for a 3% to 4% royalty plus additional payments tied to development and regulatory milestones. cliramitug is...
Gene-editing pushes and emerging risk
A fatal CRISPR-based gene-editing case in China has raised fresh questions about ethics and oversight after a young patient died following an experimental, brain-directed base-editing treatment,...
FDA compounding peptides—panel stance narrows, access expands pressure
An FDA advisory panel narrowly endorsed expanding access to certain compounded peptides, recommending broader manufacturing of four peptides—while closely weighing safety evidence, according to...
EU regulator adds orphan drug support, blocks therapy
The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued positive opinions for two orphan drugs, while rejecting an application involving an FDA-approved NPC therapy. In the...
CAR-T biomarker work aims to predict toxicity
A new analysis of Kite Pharma’s Yescarta (axi-cel) trial data identified genetic signatures associated with toxicity risk, with findings published in Science Immunology. Researchers led by Mark...
Obesity pipeline advances—Lilly retatrutide clears more Phase 3 hurdles
Eli Lilly added additional late-stage results for retatrutide, reporting top-line outcomes from two Phase 3 obesity studies that include serious type 2 diabetes and cardiovascular complications....
Drug development capital—Scribe Therapeutics launches in vivo CRISPR push
Scribe Therapeutics priced an upsized initial public offering to raise roughly $129 million, extending a busy IPO pipeline for biotech and bringing the CRISPR developer to Nasdaq under ticker...
Funding and launches—Transcripta Bio pushes neuro pipeline toward IND
Transcripta Bio raised $24 million since its Series A to advance IND-enabling studies across its neuro pipeline, targeting autism spectrum disorder (ASD) and facioscapulohumeral muscular...
Regenerative and off-the-shelf cell therapy progress for colorectal cancer
Researchers at Kobe University reported preclinical results for off-the-shelf iPSC-derived gamma delta (γδ) T cells targeting colorectal cancer. In mouse xenograft models using patient-derived...
CDMO and manufacturing consolidation—ABL Diagnostics buys Texcell
ABL Diagnostics won clearance to acquire Texcell, a viral safety and bioassay services provider spun out of the Pasteur Institute, in a €2.9 million deal. The transaction includes asset and...
Oral antiviral candidate blocks measles-like transmission in animals
A new oral antiviral candidate, GHP-88310, blocked transmission of a measles-like virus in a ferret model, according to results published in Nature Microbiology. The study, led from Georgia State...