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FDA expands approval for Apellis’ rare kidney disease drug
Apellis Pharmaceuticals won FDA approval for an expanded indication of its complement pathway drug pegcetacoplan (Empaveli), making it the second approved treatment for complement 3 glomerulopathy...
AI and computational advances boost biotech innovation
Recent advances in AI applications are reshaping biotech research and development. Researchers at NIH introduced GeneAgent, an AI agent that improves accuracy of gene-set analysis by reducing...
Bayer aims for growth with new product launches
Bayer outlined its strategy to return to growth leveraging new product launches as revenues from established drugs like Xarelto and Eylea plateau. The German pharma aims to replenish its portfolio...
FDA Clears Sarepta to Resume Duchenne Gene Therapy Shipments
The FDA reversed its earlier decision and authorized Sarepta Therapeutics to resume shipments of Elevidys, its gene therapy for ambulatory Duchenne muscular dystrophy (DMD) patients, after...
Merck Launches $3 Billion Cost-Cutting Plan to Bolster Pipeline
Merck & Co. announced a sweeping multiyear initiative aiming to cut $3 billion in annual costs by 2027, reallocating resources from mature assets to support newly launched and pipeline drugs. The...
GSK and Hengrui Pharma Ink Up to $12.5 Billion Deal for Respiratory and Oncology Assets
GSK partnered with Jiangsu Hengrui Pharmaceuticals in a licensing deal valued at up to $12.5 billion, centered on HRS-9821, a PDE3/4 inhibitor in phase I for chronic obstructive pulmonary disease...
GeneDx Reports Robust Growth with Strength in Genome and Exome Testing
Genetic diagnostics firm GeneDx posted a 49% year-over-year revenue increase in Q2 2025 to $102.7 million, fueled primarily by a 69% surge in whole-exome and whole-genome testing revenues, which...
Celcuity Breast Cancer Drug Surges on Positive Phase III Results
Minneapolis-based Celcuity’s experimental breast cancer therapy gedatolisib demonstrated significant efficacy in a phase III trial, achieving primary endpoints and substantially reducing...
Lab-Grown Beef Advances with Thicker, More Realistic Muscle Tissue
Researchers led by ETH Professor Ori Bar-Nur have successfully cultivated thicker, more anatomically realistic beef muscle tissue in laboratory settings. While official human consumption awaits...
AI-Powered Gene Set Analysis Tool Reduces Errors
Scientists at the U.S. National Library of Medicine developed GeneAgent, an artificial intelligence tool leveraging large language models (LLMs) with autonomous self-verification against...
Advances in Microbe-Based Therapeutics Controlled via Ingestible Capsules
Researchers have integrated engineered microbes with optoelectronic devices and smartphone interfaces to create the first fully controllable ingestible therapeutic platform. This system enables...
Novo Nordisk Cuts Sales Forecast Amid Obesity Drug Challenges and Names New CEO
Danish pharmaceutical leader Novo Nordisk slashed its 2025 sales growth forecast to 8%-14% from the prior 13%-21% range due to increasing competition from compounded semaglutide generics affecting...
Merck Launches $3 Billion Cost-Cutting Drive Amid Product Challenges
Merck & Co. announced a multiyear cost-reduction program aiming to save $3 billion annually by the end of 2027. The initiative will redirect resources from mature products to newer launches and...
Sarepta Cleared to Resume Duchenne Therapy Shipments for Ambulatory Patients
Following FDA investigations into safety concerns, Sarepta Therapeutics received clearance to recommence shipments of its gene therapy Elevidys for ambulatory Duchenne muscular dystrophy patients....
GeneDx Raises Revenue Forecast Amid Strong Genomic Testing Growth
GeneDx has upgraded its 2025 revenue guidance following robust second-quarter results, driven by a 49% year-over-year revenue increase. The genetic diagnostics firm saw whole-exome and...
GSK and Hengrui Ink $12.5 Billion Collaboration on Respiratory and Oncology Pipeline
GlaxoSmithKline has entered into a wide-ranging collaboration with Jiangsu Hengrui Pharmaceuticals valued at up to $12.5 billion, which includes an upfront payment of $500 million. The deal grants...
Celcuity Reports Breakthrough Phase III Data in Breast Cancer, Shares Surge
Minneapolis-based Celcuity announced positive topline results from its phase III Viktoria-1 trial evaluating gedatolisib combined with endocrine therapies in advanced HR+, HER2-, PIK3CA wild-type...
Advances in CRISPR and Genome Editing Highlighted in GEN Virtual Summit
The GEN ’s “The State of CRISPR & Genome Editing” virtual summit, broadcast June 11, 2025, featured talks from leading researchers covering novel genome editing innovations. Highlights include...
AI and Computational Innovations Boost Biotech Research and Drug Development
Multiple reports detail AI's growing role in biotech. NIH researchers unveiled GeneAgent, an AI agent reducing errors in gene-set analysis via database verification. Stanford scientists developed...
Novo Nordisk Cuts 2025 Forecast Amid Semaglutide Competition; Names New CEO
Novo Nordisk revised its 2025 sales growth projection downward to 8%-14%, from an earlier 13%-21% estimate, citing increasing competition from compounded versions of its obesity drug Wegovy and...