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Specialised Therapeutics' NIKTIMVO (axatilimab) gains Australian TGA approval for chronic graft-versus-host disease based on Ph2 data
Antibody, autoimmune, monoclonal antibody, chronic graft-versus-host disease, CSF-1R inhibitor, stem cell transplant - Read more

FDA approves Guardant Health’s Guardant360 CDx as companion diagnostic for Arvinas and Pfizer's Veppanu (vepdegestrant) in ESR1-mutated advanced breast cancer
Small molecule, cancer, PROTAC, breast cancer, ESR1 mutation, companion diagnostic - Read more

Novelty Nobility, AGC Biologics expand manufacturing partnership to advance bispecific antibody NN4101 for retinal diseases
Manufacturing agreement, Bispecific antibody, Ophthalmology, CDMO, GMP manufacturing - Read more

BioCryst Pharmaceuticals, Neopharmed Gentili license navenibart in Europe for HAE, $70M upfront, $275M milestones
Licensing deal, rare disease, small molecule, milestone payments, royalties, commercialization - Read more

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Takeda's TAK-881 (immunoglobulin 20%) meets Ph2/3 primary endpoint in primary immunodeficiency disease, showing pharmacokinetic comparability to HyQvia
Protein therapy, autoimmune, immunoglobulin, primary immunodeficiency disease, subcutaneous therapy - Read more

Mirum Pharmaceuticals' (volixibat) meets primary endpoint in Ph2b trial for primary sclerosing cholangitis-related pruritus
Small molecule, liver disease, IBAT inhibitor, primary sclerosing cholangitis, cholestatic pruritus - Read more

Lineage Cell Therapeutics' OpRegen (RG6501) Ph1/2a shows durable 3-year vision gains in geographic atrophy secondary to age-related macular degeneration
Cell therapy, eye disease, allogeneic cell therapy, geographic atrophy, age-related macular degeneration, retinal pigment epithelium - Read more

Dr. Falk Pharma and Renexxion's naronapride meets primary endpoint in Ph2b gastroparesis trial
Small molecule, metabolic, gastroparesis, prokinetic, 5-HT4 receptor agonist - Read more

Spur Therapeutics' (avigbagene parvec) Ph1/Ph2 data show bone disease improvements in Gaucher disease type 1 adults
Gene therapy, metabolic, AAV gene therapy, Gaucher disease, GCase, rare disease - Read more

Oncolytics Biotech's (pelareorep) Ph2 shows durable responses in second-line RAS-mutant microsatellite-stable metastatic colorectal cancer
Oncolytic virus, cancer, immunotherapy, colorectal cancer, RAS mutation, combination therapy - Read more

Windward Bio raises $165M crossover round, advancing TSLP-targeting immunology antibody programmes
Immunology, antibody, respiratory, dermatology, clinical-stage - Read more

Odyssey Therapeutics targets $225M IPO to advance inflammatory disease pipeline
Autoimmune, small molecule, inflammatory disease, clinical-stage, protein therapeutics - Read more

Latus Bio raises $97M Series A to advance gene therapies for Huntington's, Batten disease
Gene therapy, neurological, rare disease, Huntington's disease, clinical-stage - Read more

mbiomics raises $12M Series A, advancing microbiome-based therapeutics for severe diseases
Microbiome therapeutics, AI/ML platform, infectious disease, preclinical, live biotherapeutics - Read more

General Proximity receives undisclosed investment to expand induced proximity medicines development
Oncology, induced proximity, small molecule, platform technology, preclinical - Read more

EnteroBiotix raises £19M (25.8M), advancing microbiome therapies for gut health R&D
Microbiome therapeutics, gastrointestinal, clinical-stage, oral therapy - Read more

Amgen adds $300M to Puerto Rico biologics expansion, bringing total U.S. investment pledges near $2B
Biologics, strategic, operational, major transaction - Read more

PCI Pharma Services adds US sterile fill/finish capabilities amid $1B global expansion
Sterile fill/finish, CDMO expansion, strategic, major transaction - Read more

Obesity surpasses oncology as top biopharma pipeline value contributor for first time, per Deloitte analysis
GLP-1 receptor agonist, obesity, competitive, financial - Read more

SCOTUS temporarily restores online mifepristone access after appeals court blocked Danco, GenBioPro distribution
Small molecule, reproductive health, regulatory, operational - Read more

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Vertex Pharmaceuticals, Moderna discontinue (VX-522) Ph1/Ph2 cystic fibrosis program due to tolerability issues with CFTR mRNA therapy
Gene therapy, respiratory disease, mRNA therapy, cystic fibrosis, CFTR protein - Read more

Samsung Biologics estimates $102M financial impact as union strike involving 2,800+ workers continues
CDMO, operational, financial, labor dispute - Read more

Novartis cuts 60 more US headquarters roles in second layoff round at East Hanover site
Rare disease, oncology, cost reduction, operational - Read more

Passage Bio cuts 75% of workforce after FDA rejects single-arm trial design for PBFT02
Gene therapy, neurological, cost reduction, strategic - Read more

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