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FDA signals faster path for human-first studies; EMA backs first virtual toxicity approach
The European Medicines Agency (EMA) endorsed a new approach methodology (NAM) to generate early toxicity data using virtual control groups derived from historical animal controls, marking a first...
Lilly and Novo ignite oral obesity competition after FDA approvals and pricing battles
Eli Lilly’s oral GLP-1 agonist orforglipron won FDA approval for adults with obesity or overweight with weight-related conditions, branded Foundayo. Lilly’s therapy is positioned to enter the U.S....
Biogen pays $5.6B for Apellis to expand immunology and kidney franchise
Biogen agreed to acquire Apellis Pharmaceuticals in a $5.6 billion deal, stepping up its strategy to broaden commercialized immunology offerings and accelerate growth in nephrology. The...
CAR T regulatory milestone at University of Colorado for campus-developed therapy
The University of Colorado Anschutz Gates Institute secured Investigational New Drug (IND) clearance from the FDA for a campus-developed CAR T-cell therapy. The program is described as the first...
Gilead cancels long-acting HIV pill program amid ongoing FDA clinical hold
Gilead ended a phase 2/3 trial of long-acting HIV pills after the FDA maintained clinical hold restrictions on parts of the program. The company discontinued safety follow-up for the Wonders-2...
Regulatory and legal pressure reshapes CRISPR IP landscape
The U.S. Supreme Court denied Agilent Technologies’ request to review invalidation of two CRISPR-related patents tied to chemical modifications of guide RNAs (gRNAs), effectively ending a...
Immunovant’s FcRn inhibitor fails Phase 3 in thyroid eye disease
Immunovant’s FcRn inhibitor batoclimab failed to meet primary endpoints in two Phase 3 trials for thyroid eye disease, according to disclosures from Roivant and the company’s partner. The studies...
Ambrosia secures $100M Series B to advance oral obesity GLP-1 candidate
Ambrosia Biosciences raised a $100 million oversubscribed Series B to advance its oral obesity pipeline, including moving its lead oral small-molecule GLP-1 candidate into Phase I trials. The...
Home-grown clinical model: hydrogel-based axon platform improves MS remyelination testing
University College London (UCL) researchers developed a hydrogel-based axon model to test myelination drugs under more physiologically realistic mechanical conditions. Published in Nature Methods,...
Therapy development disrupted by trial logistics: Pfizer and BioNTech pause COVID study over enrollment
Pfizer and BioNTech paused a government-ordered U.S. post-marketing COVID-19 vaccine study after slow enrollment prevented the companies from generating relevant post-marketing data in healthy...
FDA approves Lilly’s oral GLP-1 for obesity, intensifying market rivalry
Eli Lilly’s oral weight-loss pill orforglipron (branded Foundayo) won FDA approval for adults with obesity or overweight with weight-related conditions, according to FDA announcements and company...
Ambrosia raises $100M Series B to advance oral obesity pipeline
Ambrosia Biosciences secured an oversubscribed $100 million Series B to advance its oral obesity drug pipeline, including a lead small-molecule GLP-1 candidate. The funding, co-led by Blue Owl...
Biotech dealmaking accelerates: Biogen buys Apellis for $5.6B
Biogen agreed to acquire Apellis Pharmaceuticals for $5.6 billion, adding two commercialized immune-complement assets alongside Apellis’ late-stage kidney pipeline. The purchase is expected to...
FDA and policy shift to reduce animal testing in oncology development
Regulatory and scientific updates point to a continued shift toward human-relevant preclinical models. The FDA has supported investigational pathways that rely exclusively on human data in certain...
Cancer immunotherapy: dendritic-cell mechanism reshapes ‘checkpoint gatekeeper’ strategy
A Science study from St. Jude Children’s Research Hospital mapped a tumor-driven mechanism that suppresses dendritic cells—described as immune “gatekeepers” responsible for orchestrating antitumor...
New preclinical dual HIF inhibition erases multiple tumor types with immunotherapy in mice
Researchers at Johns Hopkins University and the University of Maryland School of Pharmacy developed first-in-class small-molecule dual inhibitors of hypoxia-inducible factors 1 and 2 (HIF-1/2). In...
CAR T gets first-ever FDA approval for campus-developed therapy via IND clearance
The University of Colorado Anschutz Gates Institute received FDA Investigational New Drug (IND) clearance for a CAR T-cell therapy developed entirely on its campus. The milestone is described as...
Genomics tooling: Geneus obtains CE IVDR mark for nanopore sequencer
Chinese nanopore sequencer maker Geneus Technologies obtained CE marking under the EU’s IVDR for its desktop single-molecule nanopore platform, including the G-seq500 sequencer and G-MK02...
Virology and safety: Pfizer and BioNTech pause updated COVID trial over enrollment
Pfizer and BioNTech said they will pause enrollment in a large U.S. post-marketing COVID-19 vaccine study due to slow recruitment. The trial was designed to enroll healthy adults aged 50 to 64 and...
Deal and regulatory planning: EMA endorses first NAM to replace live animal controls in toxicity tests
The European Medicines Agency (EMA) provided initial endorsement for a new approach methodology (NAM) intended to replace live animal control groups in early toxicity testing. The method uses...