All the top Biotech & Pharma news in one daily newsletter.
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✅ The Good News ✅
THE GOOD
Approvals & Labels
GSK's Jideytro (zidesamtinib) wins FDA approval for ROS1-positive metastatic non-small cell lung cancer
Small molecule, cancer, kinase inhibitor, non-small cell lung cancer, ROS1 mutation - Read more
Takeda China wins NMPA approval for Orzeyful (oveporexton), first OX2R agonist treating narcolepsy type 1, based on Ph3 data
Small molecule, neurological, orexin receptor agonist, narcolepsy type 1, orexin deficiency - Read more
Haisco Pharmaceutical's Ciprocopan (ciprocopan succinate) wins NMPA approval for paroxysmal nocturnal hemoglobinuria as first oral complement factor B inhibitor
Small molecule, hematological disease, complement inhibitor, paroxysmal nocturnal hemoglobinuria, complement factor B - Read more
AstraZeneca's Etcamah (camizestrant) wins EU approval for oestrogen receptor-positive, HER2-negative advanced breast cancer after Ph3 success
Small molecule, cancer, oral SERD, breast cancer, ESR1 mutation, CDK4/6 inhibitor - Read more
THE GOOD
Business Development & Partnerships
Nona Biosciences, Medical University of Vienna collaborate on fully human antibody development for infectious diseases
Research collaboration, infectious disease, antibody, drug discovery- Read more
Arcus Biosciences, AVEO Oncology partner to evaluate casdatifan plus tivozanib in advanced kidney cancer
Clinical supply agreement, oncology, small molecule, co-development - Read more
Arcus Biosciences, Summit Therapeutics collaborate to evaluate casdatifan plus ivonescimab combination in kidney cancer
Clinical trial collaboration, oncology, small molecule, antibody, renal cell carcinoma - Read more
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✅ More Good News ✅
THE GOOD
Clinical Trials
J&J's Tecvayli (teclistamab) and Talvey (talquetamab) combo cuts multiple myeloma progression risk 89% in Ph3
Antibody, cancer, bispecific antibody, multiple myeloma, BCMA, GPRC5D - Read more
Eli Lilly's (retatrutide) hits Ph3 primary endpoints with 22.6% weight loss in obesity with cardiovascular disease
Small molecule, metabolic, GLP-1 receptor agonist, obesity, type 2 diabetes, cardiovascular risk - Read more
Arrowhead Pharmaceuticals' (plozasiran) Ph3 trials show up to 81% triglyceride reduction in severe hypertriglyceridemia patients
Small molecule, metabolic, siRNA, hypertriglyceridemia, triglyceride reduction, acute pancreatitis - Read more
Summit Therapeutics, Akeso's (ivonescimab) Ph3 Western data show 24% lower death risk in EGFR-mutated non-small cell lung cancer
Antibody, cancer, bispecific antibody, non-small cell lung cancer, PD-1/VEGF, EGFR mutation - Read more
THE GOOD
Fundraises
Mentari Therapeutics raises $200M private placement to advance migraine prevention biologics pipeline
Migraine, biologics, neurological, clinical-stage - Read more
Tikva Allocell closes $8M Series A to advance EBV-specific T-cell therapy for solid tumors
Cell therapy, oncology, allogeneic, solid tumors, preclinical - Read more
Transcripta Bio raises $24M in funding for AI-powered neurological drug discovery expansion
AI-driven, neurological, rare disease, drug discovery, transcriptomics - Read more
THE GOOD
Investments
BeOne Medicines commits $300M to New Jersey manufacturing expansion, adding small molecule capabilities and 120 jobs
Small molecule, oncology, operational, major transaction - Read more
THE GOOD
Politics & Policy
NIH leads $1.2B Bio Genesis Mission to halve biomedical discovery timelines using AI
Artificial intelligence, chronic disease, drug discovery, major investment - Read more
THE GOOD
Regulatory
FDA Modernization Act 3.0 passes House, directing agency to update animal testing regulations
Preclinical testing, drug development, regulatory, operational - Read more
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❌ The Bad News ❌
THE BAD
Earnings & Finances
Roche Diagnostics posts muted 3% sales growth in H1 2026 amid China pricing reform headwinds
Diagnostics, healthcare pricing reform, financial, operational - Read more
Roche reports Vabysmo US sales slump returns, offset by reduced biosimilar headwinds and pipeline hopes
Small molecule, ophthalmology, oncology, revenue impact, competitive- Read more
THE BAD
Layoffs
Clinuvel Pharmaceuticals relocates headquarters to US, cuts up to 20% of workforce in strategic restructuring
Small molecule, rare disease, operational, cost reduction, strategic - Read more
THE BAD
Regulatory
FDA flags Sanofi emails for misleadingly promoting Beyfortus as broad RSV preventative, demands immediate action
Monoclonal antibody, infectious disease, regulatory, operational - Read more
FDA issues warning letters to Almon Healthcare and Shimoga Chemicals over data, sanitation violations
Small molecule, infertility, operational, regulatory - Read more
THE BAD
Strategic Plans
Roche drops RG6382 TCE for lupus but confirms continued autoimmune cell therapy development plans
T-cell engager, autoimmune, strategic, pipeline - Read more
You’re all caught up on the latest Pharma & Biotech News!
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