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Regulatory approvals – oncology
The FDA approved Merck & Co.’s Welireg (belzutifan) in combination with Keytruda (pembrolizumab) for adjuvant clear cell renal cell carcinoma (ccRCC), marking the first approval for a PD-1 plus...
Medicare pricing and policy – drug payment mechanics
CMS moved to close a Medicare “fixed combination” drug loophole that the agency said can enable manufacturers to extend commercially protected product timelines under the Inflation Reduction Act’s...
European regulation – clinical trial process changes
The European Medicines Agency said it is preparing for “major” Clinical Trial Regulation changes tied to the incoming EU Biotech Act, aiming to reduce sponsor administrative burden while speeding...
Biopharma funding and launches – AI drug discovery
Radical Numerics launched with a $50 million seed round led by Emergence Capital as the AI biotech pushes multimodal models trained across DNA, RNA, and proteins. The company said its integrated...
Acquisitions and development programs – blood cancer
Eli Lilly presented encouraging early Phase 1 results for AJ1-11095, a type II JAK2 inhibitor in development for myelofibrosis, at the European Hematology Association meeting. The drug came...
Clinical trial readouts – ulcerative colitis
Spyre Therapeutics reported positive initial 12-week Phase 2 data for SPY002, its anti-TL1A antibody, in patients with moderately to severely active ulcerative colitis. In the Skyline program’s...
Clinical development – Alzheimer’s drug candidate update
Elixiron Immunotherapeutics said interim open-label Phase 2 results for enrupatinib in Alzheimer’s disease were positive, with plans to move into a biomarker-based, placebo-controlled study...
Program failures and restructuring – depression
Neumora Therapeutics discontinued navacaprant after both Koastal-2 and Koastal-3 Phase 3 studies failed to achieve statistical significance on primary or key secondary endpoints in major...
Venture funding and partnerships – depression precision psychiatry
German neuroscience company HMNC Brain Health closed a $50 million Series B led by Medice and signed a licensing partnership to bring two depression therapies into later-stage development. Medice...
Regulatory and clinical – diabetes indication expansion
Sanofi’s Tzield (teplizumab) gained FDA accelerated clearance for recently diagnosed stage 3 type 1 diabetes, expanding the CD3-directed monoclonal antibody’s disease-modifying use. The decision...
Oncology therapeutics updates
Lilly presented Phase 1 data for AJ1-11095, a type II JAK2 inhibitor in development for myelofibrosis, at EHA in Stockholm. The update follows Lilly’s acquisition of Ajax Therapeutics, which...
Hematology – multiplex immunotherapy signals
Johnson & Johnson reported Phase 3 data showing Darzalex Faspro plus Talvey, with or without Pomalyst, reduced risk of progression or death in earlier-line multiple myeloma. The company framed the...
Rare disease gene editing – hereditary angioedema milestone
Intellia released additional positive data for lonvoguran ziclumeran (lonvo-z), its one-time in vivo gene-editing therapy for hereditary angioedema (HAE), expanding on earlier Phase 3 endpoint...
Regulatory policy – Medicare drug price negotiation framework
CMS proposed rulemaking that would codify and tighten the Inflation Reduction Act’s Medicare Drug Price Negotiation Program, including modifications to the “fixed combination drug” policy. The...
EU regulatory operations – Clinical Trials Information System updates
The EMA said it is preparing for major Clinical Trial Regulation changes tied to the proposed EU Biotech Act expected to move forward this year. The agency said it will allocate resources to...
Immunotherapy – childhood AML targeting CD123
Researchers unveiled a pediatric oncology immunotherapy approach using an engineered immunoconjugate that combines BCG-derived Hsp70 with an anti-CD123 antibody. The strategy is designed to...
Virology and public health – HIV wastewater surveillance
Baylor College of Medicine, with collaborators across multiple institutions, published a wastewater-based method to detect HIV-1 in community sewage. The study, published in Nature Communications,...
Precision psychiatry – HMNC raises Series B and partners for depression drugs
HMNC Brain Health secured a first tranche of a $50 million Series B round led by MEDICE and simultaneously locked in an exclusive European commercialization partnership for Ketabon (KET01). The...
Corporate funding – AI biotech startup launch
Radical Numerics launched with $50 million in seed funding to build multimodal AI models trained directly on biological data spanning DNA, RNA, and proteins. The round was led by Emergence Capital...
Gene therapy and neuromuscular disease – circular RNA exon skipping
Researchers reported that a circular RNA gene therapy leveraging endogenous ADAR enabled safe and durable exon skipping repairs in human and nonhuman primate models of Duchenne muscular dystrophy....