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THE GOOD
Approvals & Labels

Regeneron's Eylea HD wins FDA approval for retinal vein occlusion macular edema and monthly dosing expansion
Protein therapy, ophthalmology, anti-VEGF, macular edema, retinal vein occlusion - Read more

Alvotech and Advanz Pharma's Gobivaz (golimumab) wins Europe approval as first Simponi biosimilar for autoimmune diseases
Antibody, autoimmune, biosimilar, golimumab, rheumatoid arthritis - Read more

Alexion's Koselugo (selumetinib) wins FDA approval for adults with neurofibromatosis type 1 following Ph3 success
Small molecule, rare disease, MEK inhibitor, neurofibromatosis type 1, plexiform neurofibromas - Read more

Poolbeg Pharma receives European patent for POLB 001 influenza treatment, strengthening IP portfolio
Small molecule, oncology, strategic, intellectual property - Read more

THE GOOD
Business Development & Partnerships

Antheia, TAPI partner to commercialize biosynthetic APIs using fermentation expertise and European manufacturing
Manufacturing agreement, biosynthetic API, fermentation technology, commercialization - Read more

GSK, Flagship's Quotient Therapeutics and ProFound Therapeutics partner on respiratory, liver disease targets, $7B potential deal value
Research collaboration, respiratory diseases, drug discovery, protein therapeutics, milestone payments - Read more

Merck KGaA, Valo Health partner on Parkinson's target discovery using AI platform, $3B potential biobucks
Research collaboration, neurological, AI/ML, milestone payments - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Pfizer's mRNA influenza vaccine shows 34.5% greater efficacy than standard shot in Ph3 trial
mRNA vaccine, infectious disease, influenza, phase 3 trial, vaccine efficacy - Read more

THE GOOD
Company Launches

Cassidy Bio launches with $8M seed funding to develop AI-driven gene editing platform
Gene editing, strategic, investment, operational - Read more

THE GOOD
Earnings & Finances

Novartis raises peak sales forecasts for cancer drugs Kisqali and Scemblix to $14B combined
Small molecule, oncology, financial, revenue impact - Read more

THE GOOD
Fundraises

Moderna secures $1.5B loan facility, targeting breakeven by 2028 amid pipeline reevaluation
mRNA platform, vaccines, oncology, rare disease, infectious disease - Read more

Aspen Neuroscience raises $115M Series C for Parkinson's cell therapy development
Neurological, cell therapy, autologous stem cells, Parkinson's disease, clinical-stage - Read more

FibroBiologics raises $4M registered direct offering, fibroblast-based therapeutics for chronic diseases
Cell therapy, chronic diseases, clinical-stage, fibroblast-based therapeutics - Read more

SciNeuro receives MJFF grant, advancing LRRK2-targeted ASO therapy for Parkinson's disease
Neurological, antisense oligonucleotide, Parkinson's disease, preclinical - Read more

SeraGene Therapeutics receives undisclosed investment, developing siRNA therapies for coagulation disorders
Rare disease, gene therapy, preclinical, blood disorders - Read more

THE GOOD
Lawsuits

Pfizer, Tris Pharma settle $41.5M Texas lawsuit over alleged ADHD drug quality fraud
Small molecule, neurological, regulatory, operational, major transaction - Read more

THE GOOD
Mergers & Acquisitions

Abbott acquires cancer test-maker Exact Sciences for $21 billion, expanding into oncology diagnostics market
Diagnostic testing, oncology, strategic, major transaction - Read more

THE GOOD
Regulatory

FDA breakthrough designations show 94% priority review rate, 72% approval success study finds
Multiple modalities, oncology, regulatory, strategic - Read more

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THE BAD
Clinical Trials

Contineum Therapeutics' PIPE-307 (M1 antagonist) fails Ph2 trial for relapsing-remitting multiple sclerosis treatment
Small molecule, autoimmune, multiple sclerosis, M1 antagonist, relapsing-remitting multiple sclerosis - Read more

THE BAD
Layoffs

Ensoma cuts 37 jobs, half its workforce, transitioning from platform research to clinical development focus
Cell therapy, rare disease, operational, cost reduction - Read more

Applied Therapeutics cuts 46% of staff, explores strategic alternatives as rare disease drug approval stalls
Small molecule, rare disease, cost reduction, operational - Read more

THE BAD
Strategic Plans

Moderna discontinues three mRNA programs including herpes vaccine amid pipeline restructuring efforts
mRNA vaccine, infectious disease, operational, cost reduction - Read more

THE UGLY
Regulatory

CDC updates website questioning vaccine-autism safety, undermining longtime position that vaccines don't cause autism
Vaccine, autism, regulatory, operational, strategic - Read more

FDA issues warning letter to Cdymax for API testing failures, investigation shortfalls at Bangalore facility
Active pharmaceutical ingredient, regulatory, operational, manufacturing quality - Read more

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

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