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IL-6 inhibitor failure reshapes cardiovascular inflammation strategy
Novo Nordisk reported that its Phase 3 ZEUS trial of the IL-6 inhibitor ziltivekimab failed to reduce major adverse cardiovascular events versus placebo. The company said the antibody inhibited...
Third-party pressure on drug pricing: 340B rebate pilot changes
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 drugs. The change...
Advisory committee clears Replimune’s RP-1 on melanoma efficacy
An FDA advisory committee voted in favor of Replimune’s experimental melanoma therapy RP-1 (suvolimogene oderparepvec), concluding that the efficacy results from the Ignyte study were evaluable...
In vivo CAR T becomes board-level focus as J&J expands Sail option
Johnson & Johnson struck a deal with Sail Biomedicines to advance in vivo CAR T therapies for immune-mediated diseases while securing an option to acquire the company. Under the collaboration, J&J...
Tempus accelerates oncology diagnostics with regulatory approvals and Personalis deal
Tempus reported strong second-quarter performance driven by continued growth in its oncology testing business and lifted full-year 2026 revenue guidance. The company said oncology testing revenue...
MRD testing demand lifts Adaptive Biotechnologies revenue outlook again
Adaptive Biotechnologies increased its 2026 revenue guidance after reporting continued growth in its minimal residual disease (MRD) testing segment in the second quarter. The company said MRD...
Radiopharma funding: Ratio raises to build clinical pipeline
Ratio Therapeutics secured a $70 million Series C to support radiopharmaceutical trial activity, according to the company’s funding announcement. The round includes participation from existing...
Public markets: Apnimed upsized IPO as FDA decision nears
Apnimed priced an upsized initial public offering to raise $192 million gross proceeds, aiming to fund continued development and an anticipated 2027 launch of its sleep apnea drug if approved. The...
Genomics tooling for clinical labs: GenomOncology integrates PacBio HiFi into reporting
GenomOncology announced it will integrate Pacific Biosciences’ HiFi whole-genome sequencing secondary analysis pipeline into its Pathology Workbench reporting platform. The company said the goal...
CNS safety and efficacy debate: Capricor deramiocel rejected by FDA adcomm
Capricor’s deramiocel was voted down by an FDA advisory committee, with members citing fragile evidence around cardiac benefit in Duchenne muscular dystrophy. The panel’s vote was 9-3 against...
In vivo CAR-T partnerships intensify in autoimmunity
Johnson & Johnson moved deeper into in vivo cell therapy by paying $785 million upfront to partner with Sail Biomedicines on autoimmune programs, with an option to acquire Sail for $2.58 billion....
FDA advisory support lifts Replimune’s melanoma approval odds
Replimune’s RP-1 won a pivotal endorsement from the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee, with panelists voting 10 to 3 that efficacy results from the Ignyte phase 2 study...
Novo Nordisk’s IL-6 strategy fails in late-stage cardiovascular outcomes
Novo Nordisk’s phase 3 Zeus trial of ziltivekimab, an IL-6 inhibitor intended to reduce cardiovascular inflammation risk, missed its primary endpoint in a population with atherosclerotic...
Endometrial cancer setback exposes Karyopharm’s funding pressure
Karyopharm’s attempt to expand selinexor (Xpovio) into endometrial cancer landed another major setback as the company’s phase 3 XPORT-EC-042 trial missed its progression-free survival primary...
Public-market momentum: Apnimed prices upsized $192M IPO for sleep apnea pill
Apnimed priced an upsized $192 million IPO to fund launch preparations for Oxnimbi (AD109), its daily oral treatment for obstructive sleep apnea. The company offered 12 million shares at $16 each,...
AI-enabled clinical trial recruitment starts to scale through acquisition
Hippocratic AI acquired Grove AI, a startup founded in 2024 that developed voice-agent technology to recruit eligible patients for clinical trials. The transaction reflects continued consolidation...
Diagnostics and lab automation: GenomOncology integrates PacBio HiFi WGS into reporting
GenomOncology announced it will integrate Pacific Biosciences’ HiFi whole-genome sequencing secondary analysis pipeline into its Pathology Workbench reporting platform. The combined workflow is...
Large-scale AI cellular models gain new pharma data pact
Relation Therapeutics expanded its AI-driven drug discovery relationship with GSK under a new deal potentially worth up to $110 million. The collaboration centers on generating large-scale...
Clinical biotech funding: Brenus Pharma extends Series A with €11M
Brenus Pharma secured an €11 million ($12.6 million) Series A extension and attracted its first APAC investor as it expands an in vivo immunotherapy platform for MSS metastatic colorectal cancer....
MRD testing growth propels Adaptive Biotechnologies guidance lift
Adaptive Biotechnologies raised its 2026 MRD revenue outlook again after strong Q2 growth in its minimal residual disease business, which accounts for more than 90% of company revenue. The company...