All the top Biotech & Pharma news in one daily newsletter.
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✅ The Good News ✅
THE GOOD
Approvals & Labels
FDA approves Merck KGaA's Pimjetmi (pimicotinib) targeting CSF-1R for tenosynovial giant cell tumour following Ph3 data
Small molecule, cancer, CSF-1R inhibitor, tenosynovial giant cell tumour, rare disease - Read more
THE GOOD
Business Development & Partnerships
Start Center for Cancer Research, IFO partner to open early-phase oncology trial site in Italy
Research collaboration, oncology, early-phase trials, clinical trial site - Read more
BioNTech acquires Scholar Rock's FDA priority review voucher for $205M to accelerate oncology pipeline
Priority review voucher, oncology, bispecific antibody, antibody-drug conjugate, co-development - Read more
PharmaLogic acquires Lantheus' CDMO business and New Jersey plant for undisclosed sum
Acquisition, radiopharmaceuticals, manufacturing, CDMO, theranostics - Read more
Vor Bio licenses RemeGen's RC298 long-acting BAFF/APRIL inhibitor for $10M upfront, $346M total
Licensing deal, autoimmune, biologics, milestone payments, equity investment - Read more
Pfizer secures $1.5B financing from Blackstone Life Sciences to fund obesity drug berobenatide development through 2028
Equity investment, obesity, small molecule, milestone payments, commercialization - Read more
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✅ More Good News ✅
THE GOOD
Clinical Trials
Amgen shares Ph3 data for (dazodalibep) targeting CD40L in systemic Sjögren's disease, showing strong ESSDAI improvements
Protein therapy, autoimmune, fusion protein, Sjögren's disease, CD40L antagonist - Read more
Beeline Medicines' (afimetoran) Ph2 data show 30-point advantage over placebo in systemic lupus erythematosus
Small molecule, autoimmune, TLR7/8 inhibitor, systemic lupus erythematosus, corticosteroid-sparing - Read more
THE GOOD
Earnings & Finances
Lundbeck raises full-year revenue and earnings forecasts after Vyepti-driven Q3 beat
Monoclonal antibody, neurological, revenue impact, financial - Read more
THE GOOD
Fundraises
Neurosterix raises $105M Series B to advance oral schizophrenia candidate into mid-stage trials
Neuropsychiatric, small molecule, schizophrenia, allosteric modulator, clinical-stage - Read more
VectorY Therapeutics raises €74.5M ($83.5M) in new financing to advance neurodegenerative gene-delivered antibody pipeline
Gene therapy, neurological, antibody, ALS, neurodegenerative, clinical-stage - Read more
Eli Radiopharma raises $60M Series A to advance radiopharmaceutical assets into clinical development
Radiopharmaceuticals, oncology, neurological, preclinical, diagnostics - Read more
THE GOOD
Investments
Cancer Research UK launches £8M ($10.6M) AI co-scientist project to accelerate cancer research discoveries
Agentic AI, oncology, operational, investment - Read more
THE GOOD
Mergers & Acquisitions
Valo Health merges with Montai Therapeutics under Valo brand to advance AI-driven drug pipeline
AI drug discovery, oncology, autoimmune, major transaction - Read more
THE GOOD
Product Launches
Sandoz launches Ranluspec ranibizumab biosimilar in Europe for affordable retinal disease treatment
Biosimilar, ophthalmology, strategic, competitive - Read more
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❌ The Bad News ❌
THE BAD
Earnings & Finances
Legend Biotech shares drop 16% after cautious Carvykti 2027 sales outlook overshadows Q3 profit
CAR-T, oncology, financial, competitive - Read more
THE BAD
Layoffs
Capricor Therapeutics cuts 10% of workforce as FDA decision on DMD cell therapy deramiocel approaches
Cell therapy, rare disease, regulatory, cost reduction - Read more
THE BAD
Market Reports
Harvard analysis warns US pressure to raise German drug prices would increase costs in both countries
Drug pricing policy, pharmaceutical industry, financial, regulatory, competitive - Read more
THE BAD
Regulatory
Eugia, unit of Aurobindo, recalls vancomycin antibiotic lot over glass particle contamination concerns
Small molecule, infectious disease, operational, safety recall - Read more
FDA quietly pauses controversial Commissioner's National Priority Voucher speedy drug review pilot program
FDA review program, small molecule, regulatory, operational - Read more
FDA warns Chongqing Qiancan Technology, Tianjin Healthcare Medical Technology over record-request refusals, issues import alerts
API manufacturing, compounding, regulatory, operational - Read more
THE BAD
Strategic Plans
Kyverna drops next-gen KYV-102 CAR-T program to focus on miv-cel autoimmune approval
CAR-T, autoimmune, strategic, pipeline - Read more
You’re all caught up on the latest Pharma & Biotech News!
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