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The Good News

THE GOOD
Approvals & Labels

FDA approves Vertex Pharmaceuticals' Casgevy (exagamglogene autotemcel) label expansion for pediatric sickle cell disease and transfusion-dependent beta thalassemia
Gene therapy, blood disorders, CRISPR, sickle cell disease, beta thalassemia, pediatric population - Read more

Novartis secures European Commission approval for Itvisma for 5q spinal muscular atrophy in patients aged two and older
Gene therapy, neurological, spinal muscular atrophy, SMN1 gene replacement, pediatric and adult patients - Read more

THE GOOD
Business Development & Partnerships

Takeda, Insilico Medicine partner on AI drug discovery using Pharma.AI platform, $600M deal, $60M upfront
Licensing deal, AI/ML, drug discovery, milestone payments, royalties - Read more

Lonza expands partnership with unnamed U.S. drugmaker, adds biologics programs, multi-billion Swiss francs potential
Manufacturing agreement, antibody-drug conjugate, biologics, CDMO, milestone payments - Read more

Regenxbio doses first patient in Ph2b/3 trial of surabgene lomparvovec for diabetic retinopathy, triggering $100M AbbVie milestone
Gene therapy, metabolic, diabetic retinopathy, AAV vector, one-time treatment - Read more

Zimmer Biomet acquires Pacira BioSciences' iovera cold-therapy pain device for up to $140M
Acquisition, medical devices, pain management, milestone payments, commercialization - Read more

AstraZeneca, CSPC Pharmaceutical Group partner on siRNA kidney disease therapies, $30M upfront, $1.77B total
Licensing deal, renal disease, AI/ML, siRNA, milestone payments, royalties - Read more

Fosun Wanbang Pharmaceutical, Junshi Biosciences sign psoriasis deal, $32M upfront, $166M milestones
Licensing deal, autoimmune, antibody, milestone payments, royalties - Read more

Mankind Pharma, Denovo Sciences partner on AI-led drug discovery to accelerate therapy development
Research collaboration, AI/ML, drug discovery, R&D - Read more

Ribo, Madrigal Pharmaceuticals achieve first siRNA candidate drug nomination milestone in MASH partnership
Co-development, metabolic disease, siRNA, milestone payments, RNA therapeutics - Read more

Nona Biosciences, Lonza collaborate to develop single-domain antibody BBB-crossing technology for CNS diseases
Research collaboration, neurological, antibody, drug discovery, licensing deal - Read more

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More Good News

THE GOOD
Clinical Trials

Roche's (divarasib) beats Amgen's Lumakras and BMS's Krazati in Ph3 KRAS G12C-mutated non-small cell lung cancer trial
Small molecule, cancer, KRAS G12C inhibitor, non-small cell lung cancer, KRAS mutation - Read more

Can-Fite BioPharma's (namodenoson) Ph2a yields positive survival data in advanced pancreatic ductal adenocarcinoma
Small molecule, cancer, adenosine receptor antagonist, pancreatic ductal adenocarcinoma, combination therapy, Wnt/β-catenin signaling - Read more

Otsuka's VOYXACT (sibeprenlimab-szsi) Ph3 data show kidney function improvement in immunoglobulin A nephropathy, supporting traditional FDA approval
Antibody, autoimmune, monoclonal antibody, IgA nephropathy, APRIL inhibitor, kidney disease - Read more

THE GOOD
Fundraises

BridgeBio attracts $1B in convertible preferred equity from Sixth Street, HealthCare Royalty for drug launches
Rare disease, small molecule, clinical-stage, cardiovascular - Read more

Elicio Therapeutics prices $15M registered direct offering for KRAS-driven cancer immunotherapy development
Clinical-stage, oncology, immunotherapy, cancer vaccine, KRAS - Read more

THE GOOD
Mergers & Acquisitions

GNI Group acquires Ayumi Pharmaceutical for ~JPY 44.8B ($275.5M), completing its global four-region biopharma strategy
Small molecule, pain management, major transaction, strategic - Read more

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The Bad News

THE BAD
Regulatory

FDA issues warning letter to Sanofi's Genzyme Ireland unit over manufacturing violations tied to Altuviiio
Recombinant protein, hemophilia, manufacturing, operational - Read more

THE BAD
Strategic Plans

Merck & Co. discontinues Ph2 MK-1167 (MK-1167) alpha-7 nicotinic acetylcholine receptor trial in Alzheimer's disease after interim futility
Small molecule, neurological, positive allosteric modulator, Alzheimer's disease, alpha-7 nicotinic acetylcholine receptor - Read more

Angitia Biopharmaceuticals terminates Ph3 trial of (AGA111) for degenerative disc disease in lumbar interbody fusion
Protein therapy, musculoskeletal, degenerative disc disease, spinal fusion, bone disorders - Read more

👹 The Ugly News 👹

THE UGLY
No Ugly News Today!

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