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FDA advisory panel and biotech regulatory momentum
Replimune’s investigational melanoma therapy RP1—given with nivolumab—won a favorable reception on an FDA advisory committee vote after earlier negative briefing documents. The company’s BLA...
Phase 3 and late-stage pipeline failures reshaping cardiovascular strategies
Novo Nordisk reported that ziltivekimab failed in a Phase 3 outcomes study, dealing a blow to the company’s inflammation-linked cardiovascular thesis. The Phase 3 Zeus trial tested the IL-6...
FDA policy shift for 340B drug rebates
HHS’ Health Resources and Services Administration unveiled details of a revised 340B rebate pilot that would allow some drug manufacturers to deny rebates for a small subset of products. Pharma...
Clinical cardiovascular repurposing after COVID-19
A randomized, double-blind, placebo-controlled trial published in Nature Communications tested whether losartan and prednisolone can influence post-COVID syndrome and signs of cardiac...
Genetic diagnostics and long-read sequencing workflow integration
GenomOncology said it will integrate Pacific Biosciences’ HiFi whole-genome sequencing secondary analysis pipeline into its Pathology Workbench reporting platform. The company’s stated goal is to...
Radiopharma funding to expand clinical development capacity
Ratio Therapeutics raised $70 million in a Series C round aimed at advancing radiopharmaceutical trials, including further work to support clinical development timelines. The company said the...
Oncology liquid biopsy growth and regulatory validation
Guardant Health reported a sharp jump in second-quarter revenue driven by stronger oncology testing volume, with Shield colorectal screening tests scaling and Guardant360 expanding after a June...
Diagnostics companies raising forecasts on testing momentum
Veracyte increased its full-year revenue guidance after beating second-quarter top- and bottom-line expectations, citing continued demand for its Decipher and Afirma cancer tests. The company...
Biotech dealmaking in in vivo CAR T and platform expansion
J&J secured a $785 million collaboration with Sail Biomedicines, including an option to acquire the in vivo CAR T firm. The deal is part of J&J’s broader push into multiple in vivo CAR T...
Regulatory and clinical progress for a new obesity drug entrant via IPO
Apnimed priced an upsized $192 million IPO to fund launch preparation for its obstructive sleep apnea drug Oxnimbi (AD109), with an FDA decision expected by February 2027. The daily pill is built...
Immuno-oncology engineering and macrophage-mediated tumor killing
A Nature Communications study led by Pagès-Geli, Ribeiro, Wienclaw and colleagues reports a high-throughput approach to engineer bispecific antibodies designed to boost macrophage killing of...
Preoperative immunotherapy in high-risk early HER2-negative breast cancer
In the adaptive I-SPY2 platform, researchers reported that a preoperative dual-immunotherapy regimen added to chemotherapy produced substantially higher tumor eradication rates in patients with...
AI evaluation for frontier drug-discovery models
Insilico Medicine launched what it says is the first Drug Discovery and Development Benchmark as a Service for frontier AI models, designed to test whether systems can make meaningful scientific...
FDA advisory support for intratumoral RP1 plus checkpoint blockade
A panel of FDA advisers voted in favor of Replimune’s oncolytic melanoma therapy RP1 when used in combination with a PD-1 inhibitor, signaling improved odds for approval after prior submissions...
NovaNordisk’s IL-6 pathway bet derailed in Phase 3
Novo Nordisk’s Phase 3 Zeus trial of ziltivekimab missed the primary endpoint in reducing major adverse cardiovascular events versus placebo. The company reported the mechanism reduced IL-6...
Public-market momentum: Apnimed upsized IPO for sleep apnea drug
Apnimed priced an upsized $192 million IPO as it advances Oxnimbi (AD109), its combination oral therapy for obstructive sleep apnea, toward a targeted FDA decision in early 2027. The company’s...
Diagnostics and companion diagnostics coverage expands for blood-based oncology
Guardant Health reported a Q2 revenue jump driven by growth in oncology testing, including an expansion of colorectal screening volume. The company also highlighted the FDA’s June approval of...
In vivo CAR T expansion in autoimmune disease through major J&J deal
Johnson & Johnson secured a $785 million collaboration with Sail Biomedicines, betting on multiple in vivo CAR T approaches aimed at autoimmune applications. Under the agreement, J&J also received...
Plasma-cell cancer trial activation: QUANTUM study for rare leukemia
The Alliance for Clinical Trials in Oncology activated the QUANTUM trial (Alliance A062401) to evaluate a bispecific immunotherapy approach in primary plasma cell leukemia, a rare and highly...
Gene therapy workflow modernization using long-read sequencing pipelines
GenomOncology said it will integrate Pacific Biosciences HiFi whole-genome sequencing secondary analysis pipeline into its Pathology Workbench reporting platform. The combined workflow is designed...