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CRISPR approval in hereditary angioedema
The FDA has approved Intellia Therapeutics’ in vivo CRISPR medicine for hereditary angioedema (HAE), delivering regulatory clearance following a Phase 3 trial and positioning lonvoguran ziclumeran...
Large pharma licensing: Abogen mRNA T-cell engager for autoimmune disease
Novartis struck a major licensing deal with Abogen Biosciences to bring an mRNA-encoded CD19xCD3 T-cell engager into its autoimmune pipeline, with the arrangement valued at up to $7.8...
Regulatory science shift: FDA FARS update to address aging and longevity
The FDA plans to update its Focus Areas of Regulatory Science (FARS) framework to highlight aging and longevity medicine, according to comments from the agency’s chief scientist at the Aging...
Clinical fail impacting development plans: Aviceda shuts down after Phase 2 miss
Aviceda Therapeutics is winding down after a Phase 2 failure tied to its eye-disease drug development strategy, according to a source familiar with the company’s decision-making. The company had...
Heart failure funding round for oral calcium-sensitizing agent
AnaCardio raised €62.5 million (about $70.5 million) in a Series B to advance its oral therapy AC01 in Phase IIb development for chronic advanced heart failure with reduced ejection fraction...
Immunology deal expansion: Sanofi and Regeneron deepen long-acting antibody pipeline
Sanofi and Regeneron expanded their long-running immunology partnership, adding four next-generation long-acting antibody programs aimed at the Dupixent (dupilumab) target space. The deal...
Clinical efficacy signal: Pfizer’s tilrekimig posts strong Phase 2 eczema clearance
Pfizer said its trispecific antibody tilrekimig met its primary goal in a mid-stage trial in atopic dermatitis, producing stronger skin clearance than placebo across multiple doses at 16...
Oncology imaging and biomarker AI: PSMA PET tracer finds prostate-to-liver cancer crossover use
A prospective pilot study in Italy found that gallium-68 PSMA-11 PET/MR and PET imaging can highlight blood vessels in liver cancer, extending the utility of a prostate cancer-targeted tracer into...
Clinical pipeline attrition and portfolio risk: Lilly reduces investment in Foghorn synthetic lethality program
Eli Lilly is ending its collaboration with Foghorn Therapeutics on a synthetic lethality program and cutting Foghorn’s headcount by about 40%, according to reporting on the partnership...
Biotech innovation funding: Parakeet Health raises $10M for automated patient outreach
Parakeet Health raised $10 million to expand its conversational agent platform that automates patient outreach, including calling, texting, and emailing patients to schedule and manage...
Big pharma strikes major RNA deal for autoimmune T-cell engager
Novartis moved to lock in an early RNA immunotherapy pipeline by licensing Abogen Biosciences’ in vivo autoimmune T-cell engager ABO2203 in a deal worth up to $7.8 billion, including $575 million...
Phase 2 readout lifts Pfizer into stronger eczema competition
Pfizer reported mid-stage efficacy for tilrekimig (a trispecific antibody targeting IL-4, IL-13 and TSLP) in a Phase 2 trial in moderate-to-severe atopic dermatitis. In the latest disclosed...
CRISPR therapy secures FDA BLA approval for hereditary angioedema
The FDA approved Intellia Therapeutics’ one-time in vivo CRISPR medicine lonvoguran ziclumeran (lonvo-z) for hereditary angioedema, clearing a key regulatory step after successful Phase 3 results....
New Biotech funding: AnaCardio pushes oral HFrEF drug to Phase IIb
AnaCardio secured a €62.5 million ($70.5 million) Series B to advance AC01, its oral calcium-sensitizing contractile agent for chronic advanced heart failure with reduced ejection fraction. The...
Immuno-oncology fails to deliver expected T-cell boost in melanoma
A clinical trial combining an IDO1 inhibitor with a therapeutic melanoma vaccine did not boost tumor-fighting T cells as intended, according to the disclosed trial results led by Craig L....
Clinical study challenges use of home AI for pediatric sleep apnea screening
A scoping review argues that AI tools for diagnosing obstructive sleep apnea from snoring-related signals still lack sufficient evidence for clinical readiness. The coverage links the limitation...
AI pathology partnerships push NSCLC companion diagnostic programs forward
CellCarta and Imagene AI expanded their partnership to coordinate AI-powered biomarker and companion diagnostic (CDx) programs through development and regulatory readiness for non-small cell lung...
Hospital bedside innovation: tiny drug-eluting implant cuts glaucoma drops in real-world data
A real-world study published in Advances in Therapy reports that a tiny drug-eluting implant placed during a short glaucoma procedure can halve the need for traditional eyedrop therapy. The...
Precision immunology: Gut microbes may shape response via regulatory B cells
A review in Cancer Immunology, Immunotherapy highlights evidence that gut microbiota can prime regulatory B cells that influence outcomes to checkpoint inhibitor therapy. The article argues that...
Platform capability: Talus Bio releases structure-free AI model for unstructured proteome binding
Talus Bioscience released Ptarmigan-1, described as a structure-free AI model designed to predict small-molecule binding sites across the entire human proteome, including proteins that are...