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Pfizer and Astellas Expand Xtandi Label With New Survival Benefits in Early Prostate Cancer
Pfizer and Astellas have announced encouraging phase 3 data from the EMBARK trial demonstrating that Xtandi (enzalutamide), in combination with leuprolide, significantly improves overall survival...
Center for Pediatric CRISPR Therapies Funded to Advance Ultra-Rare Disease Gene Editing
The Chan Zuckerberg Initiative (CZI) and Innovative Genomics Institute (IGI) have jointly funded the creation of the Center for Pediatric CRISPR Cures, aiming to develop personalized CRISPR-based...
AI Advances in Protein and Cell Modeling Enhance Drug Discovery and Biological Insights
Researchers are leveraging artificial intelligence to revolutionize protein modeling and cellular behavior predictions, significantly accelerating drug discovery. Microsoft Research has unveiled...
Cell Therapy Setback: FDA Rejects Capricor’s Duchenne Muscular Dystrophy Treatment
The FDA has issued a Complete Response Letter (CRL) rejecting Capricor Therapeutics’ marketing application for deramiocel, a cell therapy targeting cardiomyopathy in Duchenne muscular dystrophy...
Innovative Diagnostic and Therapeutic Technologies Emerge Across Cancer, Allergy, and Obesity
Several novel biotechnological advancements signal progress in diagnostics and treatments spanning oncology, immunology, and metabolic disorders. University of Chicago spinout OrisDx is preparing...
Continuous Biomanufacturing and AI Innovations Drive Efficiency in Drug Development
The biomanufacturing sector is witnessing shifts towards continuous production models promising higher yields, lower costs, and environmental benefits. Companies like Enzene Biosciences employ...
Merck's Blockbuster Respiratory Buyout Spurs Growth
Merck & Co. announced a $10 billion acquisition of London-based Verona Pharma, gaining the inhaled COPD drug Ohtuvayre, a first-in-class dual inhibitor combining bronchodilator and...
AbbVie Secures Trispecific Antibody Targeting Multiple Myeloma
AbbVie inked a sizable $700 million upfront deal for rights to ISB-2001, an early-stage trispecific antibody developed by IGI Therapeutics designed to bind three targets on multiple myeloma cells....
FDA Unveils Complete Response Letters to Boost Transparency
In a historic policy shift, the FDA released more than 200 complete response letters (CRLs) issued from 2020 to 2024 concerning drug application rejections. The letters, although redacted and...
AI-Powered Protein Design Targets Drug-Resistant Bacteria
Australian scientists at Monash University have leveraged artificial intelligence to design novel proteins that inhibit membrane transporters essential for antibiotic-resistant Escherichia coli....
Radiopharmaceutical Sector Attracts Major Funding Rounds
European radiopharma companies are raising substantial capital with funding rounds exceeding $75 million. Notably, Nuclidium AG secured $99 million to advance copper isotope-based diagnostic and...
AI and Biotech Collaborate on Accelerated Drug Discovery
Revolution Medicines formed a multi-year collaboration with AI-driven drug discovery company Iambic Therapeutics to advance oncology target discovery using AI models. Iambic will train its...
Simplified IVF Brings First Births in Mobile Lab in South Africa
In a breakthrough for reproductive health access, the first babies—Milayah and Rossouw—were born following IVF procedures conducted in a mobile laboratory designed to deliver simplified,...
Novel Cancer Enzyme Inhibition Discovered from Sea Cucumber Sugar
Researchers identified a unique sugar molecule from the sea cucumber Holothuria floridana that potently inhibits sulfatase-2 (Sulf-2), an enzyme facilitating cancer cell invasion. Structural...
New CRISPR Center to Accelerate Pediatric Gene Editing Therapies
The Chan Zuckerberg Initiative and Innovative Genomics Institute launched the Center for Pediatric CRISPR Cures, backed by a $20 million grant. The Center aims to extend personalized CRISPR gene...
Early Clinical Success for Prader-Willi Drug and Rare Obesity Oral Agent
Soleno Therapeutics reported preliminary second quarter sales of $31 to $33 million for its Prader-Willi syndrome drug Vykat XR, surpassing analyst expectations despite a high annual price point....
Merck Expands Respiratory Portfolio With $10B Verona Acquisition
Merck & Co. has agreed to acquire Verona Pharma for approximately $10 billion, adding the inhaled dual inhibitor Ohtuvayre to its respiratory pipeline. Ohtuvayre, approved by the FDA in 2024 for...
AbbVie Invests $700M in Trispecific Antibody for Multiple Myeloma
AbbVie has agreed to pay $700 million upfront to IGI Therapeutics for licensing rights to ISB-2001, a trispecific antibody candidate targeting multiple myeloma. The antibody engages three...
FDA Implements Partial Transparency With Release of Drug Rejection Letters
The U.S. Food and Drug Administration published an initial batch of over 200 complete response letters (CRLs) detailing application deficiencies from drug approval processes between 2020 and 2024....
AI and Protein Design Propel New Advances Against Resistant Bacteria and Drug Discovery
Australian researchers used artificial intelligence to design de novo proteins that inhibit the growth of antibiotic-resistant bacteria such as Escherichia coli by blocking hemoglobin transporters...