Tuesday, 9 June 2026 edition — The Vital Record

In brief

• Biotech Business GSK to buy Nuvalent for $10.6 billion, betting on two investigational lung-cancer drugs awaiting FDA decisions The all-cash deal hands GSK two investigational, selective inhibitors for genetically defined lung-cancer subsets — zidesamtinib in ROS1-positive NSCLC and neladalkib in ALK-positive NSCLC — both under FDA review, with decisions due this autumn. Neither is approved or available for prescription.
• Research Early treatment of ctDNA-positive colorectal cancer did not improve disease-free survival in the phase 3 ALTAIR trial Acting on a molecular relapse signal before scans turned positive failed to significantly extend disease-free survival, the Japanese-led randomized trial found.
• Clinical Trials Intercept ends Phase 3 obeticholic acid extension trial after FDA withdraws Ocaliva approval Intercept terminated the 62-patient long-term safety extension of obeticholic acid plus bezafibrate weeks after the FDA withdrew Ocaliva's US approval; PBC patients should not stop on their own and should ask their provider about FDA-approved alternatives.
• Devices & Diagnostics FDA Early Alert: oxygen-blender shaft in GE HealthCare Giraffe and Panda infant resuscitation systems can loosen and misdeliver oxygen An FDA Early Alert warns that a loosening blender knob shaft in certain GE HealthCare Giraffe and Panda infant resuscitation systems can deliver an oxygen concentration that does not match the setting; no serious injuries or deaths reported as of May 20, 2026.
• Digital Health & AI An AI pathology test may flag which high-risk prostate cancers benefit most from abiraterone In a post-hoc read of two STAMPEDE phase 3 trials, a locked digital-pathology model nearly halved the risk of metastasis or death from adding abiraterone — but only in the men it scored very-high-risk, and only on a surrogate endpoint.
• FDA & Regulatory FDA accepts a proposed Entyvio biosimilar for review; interchangeability not yet granted The agency will review Alvotech and Teva's application for AVT16, a vedolizumab copy for bowel disease — but the pivotal trial data came from a sibling candidate, and no interchangeability has been granted.
• Clinical Trials Takeda halts soticlestat Phase 3 extension after both pivotal epilepsy trials miss The ENDYMION 2 long-term extension was terminated after SKYLINE (Dravet, n=144) and SKYWAY (Lennox-Gastaut, n=270) failed their primary seizure endpoints.
• Research In a diabetes trial, a heart-failure drug's benefit looked largest in 121 patients carrying a cardiomyopathy gene variant — an exploratory signal A hypothesis-generating subgroup of the DECLARE-TIMI 58 trial linked dapagliflozin to a larger cut in heart-failure hospitalization among 121 carriers of a cardiomyopathy variant, but the confidence interval is wide, it sets no general diabetes benefit, is no reason to start the drug to prevent heart failure, and carriers are identifiable only by genetic sequencing.
• Biotech Business Incyte to buy Vega Therapeutics for up to $2B, betting on a subcutaneous bleeding-disorder antibody still in trials The deal hinges on VGA039, an investigational Protein S-modulating antibody now in a 60-patient Phase 3 crossover trial that has not yet reported results.
• Public Health Vaping after quitting cigarettes tied to higher lung-cancer risk in 4.5-million-person Korean cohort A nationwide Cox analysis finds ex-smokers who took up daily e-cigarettes had a 56% higher lung-cancer incidence than complete quitters.
• Devices & Diagnostics FDA clears next-gen GI Genius colonoscopy AI from Medtronic and Cosmo A Special 510(k) cleared the Module 300 hardware and ColonPRO software on May 30 as substantially equivalent — a regulatory finding, not a new efficacy trial.