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All the top Biotech & Pharma news in one daily newsletter.

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✅ The Good News ✅

THE GOOD
Approvals & Labels

AstraZeneca's Ultomiris (ravulizumab) wins FDA accelerated approval for immunoglobulin A nephropathy, its fifth indication
Antibody, autoimmune, monoclonal antibody, IgA nephropathy, complement inhibition, C5 inhibitor - Read more

Novartis wins EU label expansion for Cosentyx (secukinumab) in polymyalgia rheumatica, first IL-17A inhibitor approved based on Ph3 data
Antibody, autoimmune, monoclonal antibody, polymyalgia rheumatica, IL-17A inhibitor, secukinumab - Read more

THE GOOD
Business Development & Partnerships

Celltrion licenses Kaigene's KG013 autoimmune antibody for up to $580.5M
Licensing deal, autoimmune, antibody, milestone payments, royalties - Read more

ViiV Healthcare, Axmed partner to expand HIV medicine access across 50+ middle-income countries
Distribution agreement, infectious disease, digital health, commercialization, access to medicines - Read more

Georgiamune, Menarini Group ink exclusive global license for GIM-621, $45M upfront, $1.1B potential
Licensing deal, oncology, small molecule, immuno-oncology, milestone payments, royalties - Read more

PerturbAI, OpenAI deploy 2,000 AI agents to mine brain CRISPR data for drug target discovery
Research collaboration, AI/ML, drug discovery, neurological, rare disease - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Sitryx Therapeutics reports positive Ph1b results for (SYX-5219) targeting PKM2 in moderate to severe atopic dermatitis
Small molecule, autoimmune, PKM2 modulator, atopic dermatitis, immune metabolism - Read more

THE GOOD
Earnings & Finances

Roche's Vabysmo hits $1.38B quarterly sales, meets analyst expectations after prolonged growth slowdown
Bispecific antibody, ophthalmology, revenue impact, competitive - Read more

THE GOOD
Fundraises

Rezera plans IPO, advancing NLRP3 inhibitor ruvonoflast toward phase 3 PAD approval
Cardiovascular, small molecule, NLRP3 inhibitor, clinical-stage, anti-inflammatory - Read more

Arcus Biosciences prices $250M public offering of common stock for cancer and immune disease treatments
Oncology, autoimmune, small molecule, clinical-stage - Read more

Sinopia Biosciences receives $2.5M NIH SBIR Phase II grant, advancing AI-powered metabolomics drug discovery
AI/ML platform, drug discovery, metabolomics, multi-omics, preclinical - Read more

Arctic Therapeutics closes oversubscribed $21.5M financing to advance AT-002 and AT-003 pipeline assets
Clinical-stage, rare disease, neurological, autoimmune, small molecule - Read more

THE GOOD
Investments

Esteve CDMO invests $80M to relocate and expand China manufacturing operations for global growth
Small molecule, CDMO, operational, major transaction - Read more

THE GOOD
Mergers & Acquisitions

Hologic acquires Reveal Genomics to expand genomic breast cancer diagnostic oncology portfolio
Genomic diagnostics, oncology, strategic, major transaction - Read more

THE GOOD
Regulatory

FDA accepts Biohaven's Vyglxia (troriluzole) resubmission for spinocerebellar ataxia with advisory committee meeting planned
Small molecule, neurological, spinocerebellar ataxia, real-world evidence, glutamate modulator - Read more

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❌ The Bad News ❌

THE BAD
Clinical Trials

AbbVie's (lutikizumab) meets Ph3 primary endpoint in hidradenitis suppurativa but falls short of efficacy expectations
Antibody, autoimmune, monoclonal antibody, hidradenitis suppurativa, IL-1α/IL-1β target - Read more

THE BAD
Layoffs

Pfizer cuts hundreds of jobs across U.S. and European manufacturing plants in latest cost-savings effort
Manufacturing, biologics, cost reduction, operational - Read more

THE BAD
Regulatory

Otsuka hit with 11 UK marketing code breaches over off-label Lupkynis promotion at sponsored symposium
Small molecule, autoimmune, regulatory, operational - Read more

FDA issues warning letter to Baxter over repeated GMP failures, citing inadequate management oversight at multiple sites
Small molecule, infectious disease, operational, regulatory - Read more

THE BAD
Strategic Plans

Roche discontinues (RG6540) CD19xCD20 off-the-shelf CAR T Ph1 trials in autoimmune diseases and B cell malignancies
Cell therapy, autoimmune, CAR-T, multiple sclerosis, systemic lupus erythematosus, CD19/CD20 target - Read more

You’re all caught up on the latest Pharma & Biotech News!

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