
FDA accepts Replimune's RP1 resubmission for advanced melanoma, sets early August decision after two prior rejections | Gif: fallontonight on Giphy
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✅ The Good News ✅
THE GOOD
Approvals & Labels
Henlius' Hetronifly (serplulimab) gains European Commission approval for squamous non-small cell lung cancer first-line treatment
Antibody, cancer, monoclonal antibody, non-small cell lung cancer, PD-1 inhibitor, combination therapy - Read more
THE GOOD
Business Development & Partnerships
Komodo Health, Alnylam Pharmaceuticals expand strategic partnership to scale Marmot AI analytics platform enterprise-wide
Strategic partnership, AI/ML, data analytics, RNAi therapeutics, commercialization - Read more
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✅ More Good News ✅
THE GOOD
Clinical Trials
Epicrispr Biotechnologies’ (EPI-321) DUX4 silencer boosts muscle in facioscapulohumeral muscular dystrophy patients in Ph1/2 trial
Gene therapy, neurological, epigenetic silencing, facioscapulohumeral muscular dystrophy, DUX4 target - Read more
Abbisko Therapeutics' ABSK061 and ABSK043 (FGFR2/3 and PD-L1 inhibitors) show 90% objective response rate in Ph2 gastric cancer trial
Small molecule, cancer, FGFR inhibitor, gastric cancer, PD-L1, combination therapy - Read more
THE GOOD
Fundraises
Definium Therapeutics raises $805M upsized public offering, advancing psychiatric and neurological disorder treatments
Neurological, psychiatric disorders, small molecule, clinical-stage - Read more
LigaChem Biosciences Inc. raises 500B KRW (323K) via convertible bonds, advancing ADC pipeline and next-generation platforms
Antibody-drug conjugate, oncology, clinical-stage, platform technology - Read more
Artivila Biopharma raises $12.8M Series A, advancing AI-driven drug discovery platform
AI-driven, drug discovery, clinical-stage, platform technology - Read more
Optimeos Life Sciences receives undisclosed investment from Hatch BioFund, expanding nanoparticle drug delivery operations
Nanoparticle platform, drug delivery, rare disease, gene therapy, RNA/DNA therapeutics - Read more
Nuvation Bio prices upsized $250M convertible notes offering, debt repayment and corporate purposes
Oncology, small molecule, clinical-stage - Read more
THE GOOD
Lawsuits
Bayer wins Supreme Court ruling overturning $1.25M Roundup cancer verdict, shares surge 19%
Oncology, competitive, revenue impact - Read more
THE GOOD
Regulatory
FDA accepts Replimune's RP1 resubmission for advanced melanoma, sets early August decision after two prior rejections
Oncolytic virus, cancer, immunotherapy, melanoma, accelerated approval - Read more
THE GOOD
Strategic Plans
Moderna maps three-wave R&D roadmap at Science Day, targeting 2028 break-even with 7+ products
mRNA vaccine, oncology, rare disease, respiratory disease, strategic, financial - Read more
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❌ The Bad News ❌
THE BAD
Layoffs
Biogen cuts staff, halts most Apellis research programs one month after $5.6B acquisition
Small molecule, rare disease, major transaction, cost reduction - Read more
THE BAD
Regulatory
Amgen's Tavneos loses EU endorsement over data integrity concerns ahead of FDA hearing
Small molecule, rare disease, regulatory, competitive - Read more
Sanofi faces formal EU antitrust probe over campaign allegedly disparaging CSL Seqirus' flu vaccine Fluad
Vaccine, infectious disease, regulatory, competitive, antitrust - Read more
👹 The Ugly News 👹
THE UGLY
No Ugly News Today!
You’re all caught up on the latest Pharma & Biotech News!
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