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FDA Approves New Dosing and Tests for Alzheimer’s and Colorectal Cancer
The FDA granted approval for Eli Lilly’s revised dosing regimen of Alzheimer’s drug Kisunla to reduce the risk of brain swelling, addressing safety concerns that had limited its adoption....
ProKidney’s Kidney Disease Cell Therapy Shows Mixed Phase II Results
ProKidney Corp. reported encouraging Phase II trial results for its cell therapy rilparencel in chronic kidney disease patients, showing a 78% slowing of kidney function decline in the two-dose...
AI and Computational Tools Accelerate Cancer Drug Discovery and Protein Engineering
Partnerships and technology developments are advancing AI-driven drug discovery and protein engineering. Revolution Medicines and Iambic Therapeutics formed a multi-year collaboration leveraging...
Biopharma Industry Faces Rising Layoffs and Funding Challenges
Layoffs in the biopharma sector surged 32% year-over-year in the first half of 2025, marking an all-time high for monthly reduction-in-force rounds, with 29 reported in May alone. Several biotechs...
Innovations in Gene Editing and RNA Therapeutics
Gene editing techniques and RNA-based therapeutic platforms continue to evolve, expanding treatment potential. A CRISPR-based in vivo genome editing approach enabled mice to produce their own...
Advances in Rare Disease Therapies and Gene Therapy Trials
Novel treatments for rare diseases and gene therapies reported progress. Solid Biosciences received FDA and Health Canada clearance to begin Phase I trials for SGT-501 gene therapy targeting...
Novel Enzymes and Microbial Mechanisms Target Environmental and Biotech Applications
Scientists have uncovered enzymes and microbial functions with implications for environmental sustainability and biotechnology. Researchers at Leiden identified a common enzyme aiding bacterial...
Drug Industry Faces Regulatory, Pricing, and Legal Challenges
The pharmaceutical industry is grappling with regulatory and market complexities. Lawsuits accusing generic drugmakers of price fixing have escalated, with Southwest Airlines filing suit for...
Significant Biopharma Collaborations and Strategic Expansions
Biotech and pharmaceutical companies have entered several strategic partnerships and expansion initiatives. HeartBeat Bio and BiotxAI formed a collaboration to discover and validate genomic...
Merck’s $10B Push Into Lung Disease via Verona Pharma Buy
Merck announced a $10 billion acquisition of Verona Pharma to enhance its respiratory disease portfolio, focusing on chronic obstructive pulmonary disease (COPD). The deal includes the recently...
KalVista Secures FDA Approval for Oral Hereditary Angioedema Drug Ekterly
KalVista Pharmaceuticals won FDA approval for Ekterly (sebetralstat), the first oral on-demand therapy for hereditary angioedema (HAE) attacks in patients aged 12 and older. The approval follows a...
ProKidney’s Cell Therapy Shows Promise Amid Mixed Clinical Trial Results
ProKidney’s rilparencel, a cell therapy for chronic kidney disease (CKD), presented mixed findings in a phase 2 trial. One cohort receiving two injections demonstrated a significant 78% slowing in...
Cogent Biosciences Advances FDA Submission for Mastocytosis Treatment
Cogent Biosciences reported positive phase 2 results for bezuclastinib, targeting non-advanced systemic mastocytosis. The drug achieved statistically significant improvements in symptom scores and...
AI and Collaborative Platforms Drive Innovation in Oncology Drug Discovery
Revolution Medicines and Iambic Therapeutics have partnered in a multi-year collaboration to harness AI technology for cancer drug discovery. Iambic will train its NeuralPLexer AI model using...
Novel Gene Therapy for Deafness Shows Hearing Restoration Across Ages
A recent trial in China demonstrated promising results for AAV-OTOF gene therapy in treating autosomal recessive deafness 9. Ten participants aged 1.5 to 23.9 years showed significant hearing...
Expansion and Strategic Growth in Biopharma Manufacturing and AI Drug Discovery
Cytiva disclosed plans to complete $1.6 billion in expansions across the US, Europe, and Asia, to meet rising demand for biopharma manufacturing capabilities and promote in-region production....
Regulatory and Litigation Developments with Potential Biotech Market Impact
FDA efforts to reduce animal testing were reaffirmed by Commissioner Marty Makary, emphasizing streamlined drug development. Meanwhile, a federal lawsuit challenges recent federal changes to...
Breakthroughs in RNA and Protein Therapeutics Enabled by AI and Novel Platforms
Emerging studies reveal advances in RNA therapeutics and protein degraders, with AI-driven methods spotlighting novel targets and improving treatment efficacy. A machine learning approach now...
Radiopharmaceuticals Surge with Actithera's $75M Clinic Entry
Actithera, a pioneering radiopharmaceutical biotech based in Oslo and Cambridge, secured nearly $76 million in Series A financing to progress its novel cancer therapy pipeline targeting fibroblast...
KalVista's Oral Therapy Gets FDA Nod for Hereditary Angioedema
KalVista Pharmaceuticals won FDA accelerated approval for Ekterly (sebetralstat), the first oral on-demand treatment for hereditary angioedema (HAE) in patients aged 12 and older. The approval...