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FDA Clears First DPP1 Inhibitor for Bronchiectasis Treatment – Insmed’s Brinsupri Launches
The U.S. FDA granted approval for Insmed’s Brinsupri (brensocatib), marking the first treatment for non-cystic fibrosis bronchiectasis (NCFB). This oral DPP1 inhibitor targets neutrophilic...
Bayer Joins Kumquat in $1.3B Race to Target KRAS G12D Mutation in Cancer
Bayer has entered a collaboration with Kumquat Biosciences to develop Kumquat’s investigational KRAS G12D inhibitor for pancreatic, colorectal, and lung cancers. The deal could deliver over $1.3...
AI and Deep Learning Propel Genome Editing Precision with Deep-Learning Design
Researchers at the University of Zurich have developed 'Pythia,' an AI tool that predicts cellular DNA repair outcomes post-CRISPR editing to design microhomology-based DNA repair templates. This...
Generative AI Designs Small Enzymes for Enhanced Bioprocessing Efficiency
Scientists led by Hiroyuki Hamada at Kyushu University have leveraged ProtGPT2, a protein language model, to design smaller, novel variants of malate dehydrogenase enzymes for bioprocessing. This...
Cancer Vaccine for Melanoma Narrowly Misses Phase 3 Endpoint but Eyes FDA Pathway
IO Biotech’s off-the-shelf cancer vaccine, Cylembio, combined with Merck’s Keytruda narrowly failed to achieve statistically significant progression-free survival in a pivotal phase 3 trial for...
Novartis Scores Multiple Phase 3 Wins in Autoimmune Diseases with Ianalumab
Novartis announced positive results from two Phase 3 studies of its B-cell depleting antibody, ianalumab, in Sjögren’s syndrome and primary immune thrombocytopenia (ITP). Both trials achieved...
AI Innovations Accelerate Cell Therapy Manufacturing and Clinical Predictions
Partnerships and studies illustrate AI’s expanding role in biotech: Sartorius Stedim Biotech and Nanotein Technologies collaborate to boost immune cell expansion for cell therapy applications via...
FDA Regulatory Movements and Leadership Shakeups Shape Biotech Landscape
The FDA approved Boehringer Ingelheim’s oral HER2-targeted drug Hernexeos for non-small-cell lung cancer, accompanied by clearance of Oncomine Dx Target Test as its companion diagnostic....
New Protein Therapy Offers Potential Antidote for Carbon Monoxide Poisoning
University of Maryland School of Medicine researchers engineered a novel protein-based antidote demonstrating promising efficacy in rapidly removing carbon monoxide with fewer adverse effects...
PureTech Spins Out Lung Disease Drug to New Subsidiary Celea Therapeutics
PureTech Health has launched Celea Therapeutics to advance its drug candidate deupirfenidone (LYT-100) targeting idiopathic pulmonary fibrosis (IPF) and other inflammatory lung diseases....
Pfizer’s Padcev Shows Survival Benefit in Bladder Cancer with Keytruda Combo
Pfizer reported positive early data from a bladder cancer trial combining its antibody-drug conjugate Padcev with Merck’s Keytruda. The combo extended event-free survival and overall survival in...
Novartis Secures Multiple Phase 3 Wins with Antibody Ianalumab in Autoimmune Diseases
Novartis announced positive Phase 3 results for its B cell-targeting antibody ianalumab in Sjögren’s syndrome and primary immune thrombocytopenia (ITP). Both large registrational trials...
AI and Machine Learning Drive Advances in Biotech Research and Drug Discovery
Several breakthroughs demonstrate AI’s growing role in biotechnology: Imperial College London and GSK developed a hybrid machine learning model improving monoclonal antibody design space...
FDA Approves Insmed’s Brensocatib as First Treatment for Non-Cystic Fibrosis Bronchiectasis
The FDA granted approval to Brinsuprí (brensocatib), an oral DPP1 inhibitor developed by Insmed for treating non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and older. This marks the...
Cancer Vaccine Cylembio Narrowly Misses Primary Endpoint but Plans FDA Filing
IO Biotech’s off-the-shelf cancer vaccine Cylembio in combination with Merck’s Keytruda demonstrated encouraging but narrowly missed statistically significant improvement in progression-free...
Advances in Antibody and Cell Therapy Manufacturing Partnerships
Sartorius Stedim Biotech entered a partnership with Nanotein Technologies involving a $3 million minority investment to commercialize and co-develop products that enhance immune cell...
Regulatory Developments and Leadership Changes at the FDA
Vinay Prasad was reinstated as director of the FDA’s Center for Biologics Evaluation and Research (CBER) two weeks after his removal amid political controversy. His return elicited a muted market...
Neuroscience Breakthroughs in Brain Aging, Neurodegeneration, and Biomarkers
Recent studies unveiled significant insights into brain aging and neurodegenerative diseases: Researchers showed nuanced layer-specific cortical aging patterns in mice and humans. A new molecular...
Boston Life Sciences Market Faces Real Estate Overcapacity and Funding Slowdown
Greater Boston’s life sciences real estate market confronts a record 17 million square feet of vacant lab space amid cooling venture capital funding and macroeconomic headwinds. New speculative...
Novartis Cleaves Autoimmune Disease with Dual Phase 3 Wins
Novartis announced significant progress in treating Sjögren's syndrome with its B-cell-targeting antibody ianalumab. The drug met primary endpoints in two late-stage Phase 3 trials, marking the...