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FDA and Industry Leaders Engage on PDUFA and Pricing Policies
Key regulatory discussions are underway focusing on the Prescription Drug User Fee Act (PDUFA) reauthorization and Medicare drug pricing policies. FDA leaders, along with industry representatives...
Pfizer-Part D Drug Pricing Deal Sparks Industry Debate
Pfizer's recent 'most favored nation' deal with the U.S. government on Medicare Part D drug pricing marks a critical precedent for future presidential negotiations impacting drug costs. Despite...
Jazz Pharmaceuticals and Roche Win FDA Nod for Lung Cancer Combo
The FDA approved the first-line maintenance therapy combining Jazz Pharmaceuticals' Zepzelca (lurbinectedin) with Roche's Tecentriq for extensive-stage small-cell lung cancer patients not...
Cartography Biosciences Secures $67M Series B to Advance Cancer Pipeline
Cartography Biosciences closed a $67 million Series B financing led by Pfizer Ventures and Amgen Ventures to advance its lead programs focused on innovative T-cell engaging bispecific and...
Breakthrough Enzyme Technology Enables Universal Donor Organ Transplants
Researchers at the University of British Columbia reported the first human transplant of an ABO-incompatible kidney converted from blood type A to universal type O using engineered enzymes....
AI Accelerates Drug Discovery with Pharma Consortium’s Structural Data Pool
A coalition of pharmaceutical companies has pooled thousands of experimentally determined protein-ligand structural data to train an advanced large language model, aiming to boost the power and...
Amgen’s Repatha Demonstrates Expanded Cardiovascular Benefits in Large Trial
Amgen announced landmark trial results showing its cholesterol-lowering drug Repatha significantly reduces heart disease deaths, heart attacks, and strokes in a primary prevention population. This...
Advanced AI Reveals New Antibiotics Against Inflammatory Bowel Disease
Researchers from McMaster University and MIT utilized generative artificial intelligence to discover enterololin, a narrow-spectrum antibiotic targeting Enterobacteriaceae associated with...
NIH Funding Cuts and Government Shutdown Threaten Biotech Innovation
The ongoing U.S. government shutdown combined with significant NIH budget cuts poses substantial risks to biomedical innovation, particularly early-stage research and clinical trials. This funding...
Novel Psilocybin Treatment Shows Dual Efficacy for Chronic Pain and Depression
A study at the University of Pennsylvania demonstrated that a single dose of psilocybin rapidly and durably alleviates both chronic pain and anxiodepressive behaviors in mouse models. Targeting...
AI Protein Design Signals Biosecurity Challenges for DNA Synthesis Screening
A Microsoft-led team demonstrated that generative AI models can redesign toxic proteins to evade current DNA synthesis biosecurity screening software, raising concerns about dual-use risks. While...
Jazz-Roche Gains FDA Nod for Lung Cancer Combo Ahead of Deadline
The FDA has approved a new first-line maintenance therapy for extensive-stage small-cell lung cancer, combining Jazz Pharmaceuticals' Zepzelca (lurbinectedin) with Roche's Tecentriq...
Groundbreaking Universal Donor Kidney Transplant Achieved with UBC Enzyme Technology
The University of British Columbia researchers have successfully transplanted a kidney converted from blood type A to universal donor type O using specialized enzymes developed over a decade. This...
AI Discovers Novel Antibiotic Targeting Inflammatory Bowel Disease and Infectious Bacteria
Researchers at McMaster University and MIT have leveraged generative artificial intelligence to pioneer enterololin, a novel narrow-spectrum antibiotic designed to selectively target pathogenic...
Cartography Biosciences Secures $67 Million Series B to Advance Colorectal Cancer Therapeutics
Bay Area startup Cartography Biosciences has closed a $67 million Series B financing led by Pfizer Ventures, aimed at advancing its pipeline of T-cell engaging bispecific and multispecific...
NIH Director Firing Amid Whistleblower Complaint Raises Concerns on Vaccine Policy and Institutional Stability
Dr. Jeanne Marrazzo, former director of NIH's National Institute of Allergy and Infectious Diseases, alleges that she was terminated three weeks after filing a whistleblower complaint concerning...
Amgen’s PCSK9 Inhibitor Repatha Demonstrates Heart Risk Reduction in Broad Prevention Trial
Amgen announced that its cholesterol-lowering injectable drug Repatha significantly reduced risk of heart disease death, heart attack, and stroke in a 12,000-patient clinical trial focusing on...
AI Protein Design Tools Pose Emerging Biosecurity Risks Amid Dual-Use Concerns
A Microsoft-led research team has demonstrated that generative AI protein design platforms can modify toxic proteins to evade current DNA synthesis screening software while maintaining...
Synthetic Biology Advances: Integra Therapeutics Designs Superior Genome-Editing Proteins
Researchers at Integra Therapeutics, in collaboration with Pompeu Fabra University and the Center for Genomic Regulation, have developed and experimentally validated synthetic proteins that...
Unprecedented Genetic Map of Human Metabolism Charts Thousands of Metabolite-Gene Associations
Researchers have created the largest genetic map of human metabolism to date by analyzing data from approximately 450,000 UK Biobank participants across multiple ancestries. Published in Nature...