
Roche's Vabysmo hits $1.38B quarterly sales, meets analyst expectations after prolonged growth slowdown | Gif: fallontonight on Giphy
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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