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THE GOOD
Approvals & Labels

Health Canada approves Pfizer/BioNTech's COMIRNATY LP.8.1 variant vaccine for COVID-19 in ages 6 Months+
Vaccine, infectious disease, mRNA vaccine, COVID-19, Omicron variant, pediatric population - Read more

EU approves Madrigal's Rezdiffra, first thyroid receptor-β therapy for non-cirrhotic metabolic dysfunction-associated steatohepatitis with fibrosis
Small molecule, metabolic, thyroid hormone receptor agonist, metabolic dysfunction-associated steatohepatitis (MASH), liver fibrosis - Read more

Health Canada approves Novo Nordisk's Ozempic (semaglutide) for chronic kidney disease in type 2 diabetes patients
Small molecule, metabolic, GLP-1 receptor agonist, type 2 diabetes, chronic kidney disease, cardio-renal protection - Read more

THE GOOD
Business Development & Partnerships

Halda, VantAI partner on "hold-and-kill" RIPTAC drug targets for cancer therapy in potential $1B collaboration
Research collaboration, oncology, AI/ML, small molecule, immunology, milestone payments - Read more

Santhera, Uniphar partner for AGAMREE distribution in five GCC countries for Duchenne muscular dystrophy treatment
Distribution agreement, rare disease, commercialization, Middle East - Read more

BioMedX, Novo Nordisk partner on novel oral peptide delivery formulations to extend gut retention and improve absorption
Research collaboration, drug delivery, peptide therapeutics, oral formulation, R&D, gastrointestinal - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Celldex's Ph2 study: Barzolvolimab meets mast cell endpoint in eosinophilic esophagitis but misses clinical outcomes
Antibody, autoimmune, monoclonal antibody, eosinophilic esophagitis, mast cell depletion, KIT-targeting - Read more

THE GOOD
Earnings & Finances

Leo Pharma reports strong US sales growth from Adbry, with Anzupgo launch boosting 2025 outlook
JAK inhibitor, dermatology, financial growth, strategic transformation, market expansion - Read more

THE GOOD
Fundraises

Convoke raises $8.6M seed funding for AI operating system to accelerate biopharma development
AI/ML platform, software platform, biopharma, platform-enabled, data analytics - Read more

CorriXR Therapeutics raises $1M state investment, advancing solid tumor gene editing treatments
Oncology, gene therapy, solid tumors, platform technology, preclinical - Read more

Sensorium raises $25M Series A extension for plant-derived anxiety drug trial
Neurological, small molecule, plant-derived, anxiety, platform technology, clinical-stage - Read more [Paywall]

Axelyf raises $2.6M seed funding, developing RNA delivery with lipid nanoparticle tech
Platform technology, lipid nanoparticle delivery, RNA therapeutics, AI/ML platform, preclinical - Read more

NovaBay Pharmaceuticals secures $6M investment from David Lazar
Equity investment, acquisition, C-suite changes, financing - Read more

THE GOOD
Lawsuits

Amgen's ChemoCentryx wins investor lawsuit alleging fraud about Tavneos safety data; drug now generating $256M annually
Small molecule, autoimmune, rare disease, legal, financial, regulatory - Read more

THE GOOD
Market Reports

Pfizer, Regeneron, and Bristol Myers Squibb lead US pharma giants in Q2 sales recovery after Q1 declines
Pharmaceutical industry, financial, revenue impact, strategic, competitive - Read more

THE GOOD
Product Launches

Bayer launches Mexican-popular Aspirina pain reliever in US, targeting Hispanic consumers
NSAID, pain management, consumer health, product launch, market expansion, diversity strategy - Read more

THE GOOD
Regulatory

FDA releases draft guidance for optimizing oncology therapeutic radiopharmaceutical dosages during clinical development
Radiopharmaceutical therapy, oncology, regulatory, clinical development - Read more

THE BAD
Approvals & Labels

FDA rejects PTC Therapeutics' vatiquinone for Friedreich's ataxia, citing insufficient efficacy evidence in Ph3 trial
Small molecule, neurological, Friedreich's ataxia, rare disease, failed clinical trial, mitochondrial dysfunction - Read more

THE BAD
Clinical Trials

Viking Therapeutics' GLP-1/GIP obesity pill VK2735 shows 12% weight loss in Ph2, disappointing investors and cratering stock
Small molecule, metabolic, GIP/GLP-1 agonist, obesity, oral therapy - Read more

THE BAD
Layoffs

CSL to cut 15% of workforce, reduce R&D costs and spin out vaccine unit in restructuring plan
Vaccines, infectious disease, operational, cost reduction, strategic restructuring - Read more

Opthea cuts 85% of staff following eye disease drug failures, loses CEO amid financial restructuring
Small molecule, ophthalmology, clinical failure, financial impact, restructuring - Read more

THE BAD
Regulatory

FDA halts BiomX's cystic fibrosis trial due to nebulizer device concerns, not phage therapy itself
Phage therapy, cystic fibrosis, regulatory, operational, delivery device - Read more

THE UGLY
Regulatory

Regenxbio's Hunter syndrome gene therapy faces three-month FDA review delay - from Nov 2025 to Feb 2026
Gene therapy, rare disease, regulatory, Hunter syndrome, orphan drug - Read more

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

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