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Apellis’ Empaveli Gains FDA Approval for Rare Kidney Conditions
Apellis Pharmaceuticals secured FDA approval for a supplemental new drug application expanding the use of its complement C3 inhibitor pegcetacoplan (Empaveli) to treat complement 3 glomerulopathy...
Merck’s $3B Cost-Cutting Push Amid Patent Losses
Merck & Co. revealed a sweeping initiative to cut costs by $3 billion annually by 2027, reallocating resources from mature products towards new drugs and experimental medicines. The effort aims to...
Novo Nordisk Downgrades Outlook Amid Obesity Drug Competition
Novo Nordisk lowered its full-year sales forecast for 2025 to 8-14% growth, down from the earlier 13-21% estimate, citing ongoing challenges from cheaper knockoff versions of its obesity drug...
Sarepta Cleared to Resume Duchenne Therapy Shipments
The FDA reversed a recent decision and authorized Sarepta Therapeutics to resume shipping its gene therapy Elevidys to ambulatory patients with Duchenne muscular dystrophy after concluding a...
Celcuity’s Breast Cancer Combo Surges With Phase III Success
Minneapolis-based Celcuity reported positive topline results from its phase III Viktoria-1 trial evaluating gedatolisib-based combinations for hormone receptor-positive, HER2-negative breast...
GSK’s $12.5B Deal with Hengrui for COPD and More
GlaxoSmithKline finalized a multi-billion dollar licensing agreement with Jiangsu Hengrui Pharmaceuticals granting rights to the potential best-in-class phosphodiesterase inhibitor HRS-9821 for...
Radiopharmaceutical Startup Artbio Raises $132M
European radiopharmaceutical company Artbio Therapeutics secured $132 million in Series B funding to advance its prostate cancer radioligand program into phase 2 clinical trials and expand its...
AI in Pharma: Sanofi CEO Advocates for AI in Decision-Making
Sanofi CEO Paul Hudson stressed at Davos the value of AI in drug development decisions, highlighting that AI agents provide dispassionate recommendations without career bias. The company uses AI...
NeoGenomics Revises Guidance After Q2 Revenue Growth Slows
NeoGenomics reported a 10% revenue increase for the second quarter driven by clinical testing growth but slashed full-year revenue and earnings forecasts following delays and challenges in...
Advances in Gene Set Analysis via AI-Verified Model
The NIH unveiled GeneAgent, an artificial intelligence system that mitigates hallucination errors in gene function prediction by autonomously cross-verifying outputs against curated biological...
GeneDx Posts 49% Q2 Revenue Surge Fueled by Genome Testing
GeneDx reported a 49% increase in second-quarter revenues to $102.7 million, surpassing Wall Street estimates and marking its fourth consecutive profitable quarter. The growth was primarily driven...
Sarepta Resumes Duchenne Gene Therapy Shipments After FDA Reversal
Sarepta Therapeutics has recommenced shipments of its gene therapy Elevidys® to ambulatory patients with Duchenne muscular dystrophy following a brief FDA-mandated pause. The reversal comes after...
Merck Launches $3 Billion Annual Cost-Cutting Plan by 2027
Merck announced an extensive cost reduction program aimed at saving $3 billion annually by 2027 to offset declining sales of Gardasil and upcoming patent expiration of Keytruda. The multiyear...
Labcorp Secures CE-IVDR Mark for Pan-Solid Tumor Profiling Test
Labcorp announced it received CE-IVDR marking from European regulators for its PGDx Elio Tissue Complete assay, a next-generation sequencing test for pan-solid tumor profiling. This regulatory...
Artbio Raises $132 Million Series B To Advance Radiopharmaceuticals
European radiopharmaceutical startup Artbio secured a $132 million Series B financing to propel its lead prostate cancer alpha radioligand therapeutic into early clinical testing. The funding will...
Celcuity Breast Cancer Combo Hits Phase 3 Endpoints, Shares Surge
Celcuity announced positive top-line results from a Phase 3 trial evaluating its experimental breast cancer drug gedatolisib in combination with standard therapies for hormone receptor-positive,...
GSK Inks $500M Upfront Deal with Hengrui for Respiratory Pipeline
GSK entered into a licensing agreement with Jiangsu Hengrui Pharmaceuticals for rights to a Phase I inhibitor targeting COPD along with 11 additional clinical programs in immunology and oncology....
Adaptimmune Sells Cell Therapy Assets Amid Financial Struggles
Adaptimmune announced the sale of its approved sarcoma therapy Tecelra and two late-stage clinical assets to US WorldMeds for $55 million upfront, with potential additional milestone payments. The...
AI Agents Advance Gene Set Analysis with Higher Accuracy
Researchers at the NIH developed GeneAgent, an AI-driven large language model system that autonomously verifies gene-set functional analysis predictions against expert-curated biological...
OpenAI CEO Highlights AI’s Growing Diagnostic Accuracy Over Physicians
OpenAI CEO Sam Altman stated that AI diagnostic tools have achieved accuracy levels superior to many human doctors. Altman pointed to AI’s potential to improve decision-making in drug development...