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Advances in Gene and Cell Therapy: Regulatory and Development Highlights
Recent advancements mark critical progress in gene and cell therapy. Kriya Therapeutics raised $313 million to fuel development of a diverse pipeline including neurology and ophthalmology...
Breakthrough in Large-Scale Single-Cell Arabidopsis Life Cycle Mapping
Researchers have successfully created a comprehensive single-cell, spatial transcriptomic atlas of the Arabidopsis thaliana life cycle. By using advanced spatial transcriptomics, this work maps...
Viking Therapeutics’ Oral Obesity Drug Drives Weight Loss but With High Discontinuation
Viking Therapeutics reported encouraging Phase 2 results for its oral obesity drug candidate VK-2735, showing statistically significant weight reductions of up to 12.2% after 13 weeks. However,...
CSL to Spin Off Seqirus Vaccine Unit and Implement Workforce Cuts
Australian drugmaker CSL announced a major restructuring plan involving up to 15% workforce reductions and the spin-off of its vaccine subsidiary Seqirus into a standalone public company. The move...
AI-Driven Collaboration to Advance Proximity-Based Therapeutics in Oncology and Immunology
VantAI, an AI firm specializing in programmable protein interactions, has entered a $1 billion+ partnership with clinical-stage biotech Halda Therapeutics. The collaboration leverages VantAI's...
FDA Rejects PTC's Friedreich’s Ataxia Drug, Requests Additional Trial
The FDA issued a complete response letter denying approval for PTC Therapeutics’ vatiquinone for Friedreich’s ataxia, citing insufficient evidence of efficacy. The regulatory agency requested an...
Novo Nordisk’s Wegovy Gains FDA Approval for Fatty Liver Disease (MASH)
Novo Nordisk’s GLP-1 agonist Wegovy received FDA accelerated approval as the first drug indicated for metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver...
Anocca Secures $46 Million for TCR T-Cell Therapy Targeting Pancreatic Cancer
Swedish biotech Anocca AB raised approximately $46 million (SEK 440 million) to advance its CRISPR-edited T-cell receptor (TCR) therapy, VIDAR-1, in Phase I clinical trials for pancreatic ductal...
Skyhawk Therapeutics Teams with Merck KGaA on Up to $2 Billion RNA-Targeted Neurology Pact
Skyhawk Therapeutics entered a collaborative agreement with Merck KGaA focused on discovering small-molecule RNA splicing modulators for neurological diseases. The deal, valued up to $2 billion,...
Groundbreaking Lab-Grown Human Spinal Cord Stem Cells Poised for First Human Transplant
Israeli researchers at Tel Aviv University successfully bioengineered human spinal cord stem cells in the laboratory, demonstrating unprecedented success in animal models. The technology,...
Novo Nordisk’s Wegovy Expands MASH Indication: FDA Accelerates Approval
Novo Nordisk’s popular GLP-1 drug Wegovy has secured accelerated FDA approval for metabolic dysfunction-associated steatohepatitis (MASH), addressing a condition affecting an estimated 22 million...
Skyhawk Therapeutics Scores $2B Neurology RNA Deal with Merck KGaA
Skyhawk Therapeutics has entered a substantial collaboration with Merck KGaA, targeting neurological diseases through RNA splicing modulation with an agreement worth up to $2 billion. The...
PTC Therapeutics’ Friedreich’s Ataxia Drug Rejected by FDA
PTC Therapeutics received a complete response letter from the FDA rejecting its Friedreich’s ataxia drug vatiquinone, citing insufficient evidence of efficacy in the phase III Move-FA trial....
Anocca Raises $46M to Advance Genome-Edited TCR T-cell Pancreatic Cancer Therapy
Sweden-based Anocca AB secured $46 million (SEK 440 million) to fund a phase I trial of its CRISPR-edited T-cell receptor (TCR) therapy, VIDAR-1, targeting mutant KRAS in pancreatic ductal...
Stealth BioTherapeutics Resubmits FDA Application for Rare Barth Syndrome Drug
Stealth BioTherapeutics has resubmitted its investigational drug for Barth syndrome to the FDA after a previous rejection in May. The company aims to address the agency’s concerns with new data...
George Church’s Lab Advances Creation of Human Eggs In Vitro
Researchers at Harvard University led by George Church have developed a stem cell differentiation method that induces meiosis, progressing toward the generation of human eggs in a dish. This...
Natera Reports Survival Benefit Using Signatera in Bladder Cancer Trial
Natera announced statistically significant improvement in disease-free and overall survival for Signatera-positive patients receiving Genentech’s Tecentriq in the Phase III IMvigor011 trial for...
Daewoong’s Microneedle Patch Delivers Weekly Semaglutide with High Bioavailability
Daewoong Pharmaceutical Co. Ltd. and Daewoong Therapeutics Inc. achieved 80% relative bioavailability of semaglutide via a self-developed microneedle patch in a pilot human pharmacokinetic study....
Biopharma Dealmaking Surges with Record $164 Billion Activity in 2025
In the first seven months of 2025, non-M&A biopharma deal activity soared to $164.03 billion, a 36% increase over the same period in 2024 and reaching record levels. Despite fewer transactions,...
Remegen’s Telitacicept Meets Phase III Endpoint in Sjögren's Syndrome
Remegen Co. Ltd. reported that telitacicept (RC-18) achieved the primary endpoint in a Phase III trial for primary Sjögren's syndrome, an autoimmune disease causing dry eyes and mouth. The company...