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Moderna and Merck claim a hard-won melanoma vaccine breakthrough
2 days ago•Source: STAT
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2.41 min•7 days ago
Personalized mRNA melanoma vaccine with Keytruda shows Phase 3 promise
Merck and Moderna reported that a personalized neoantigen mRNA vaccine, intismeran, added to Merck's Keytruda in adjuvant melanoma slowed recurrence and metastasis in a Phase 3 trial, signaling a potential new class of cancer immunotherapies, though detailed data have yet to be released.
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Zipalertinib combo shows first-line promise in EGFR exon 20 NSCLC
Fierce Biotech•13 days ago
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AI Slashes Time and Costs in Late-Stage Cancer Trials, Tufts Finds
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Oncofertility tech gives young cancer patients a path to parenthood
A growing field called oncofertility helps younger cancer patients preserve fertility alongside treatment, using methods such as egg freezing and ovarian tissue preservation; cases like Jenilee Crowley, who paused hormone therapy to freeze embryos and welcome a son, illustrate both the possibilities and the time-sensitive challenges of fertility preservation. Costs can reach about $20,000 without insurance, and coverage varies by state, though several New England states have enacted laws to expand benefits and nonprofits like Worth the Wait help with storage costs. New research from Dana-Farber suggests that delaying pregnancy by pausing therapy does not necessarily raise recurrence risk, offering survivors a viable path to biological children after cancer.
FDA clears RP1 melanoma therapy after regulatory rollercoaster
The FDA granted accelerated approval for Replimune's RP1 (brand Tudriqev) for advanced melanoma after an advisory panel backed efficacy signals despite concerns about trial design, ending a regulatory saga that included two prior rejections; the therapy is priced at $450,000 per course.
Georgia Woman Sues Kaiser After Lab Mix-Up Causes Unnecessary Hysterectomy
A 43-year-old Georgia woman, Cassandra Barksdale, alleges a mislabeled tissue sample at Kaiser Permanente led to an unnecessary total hysterectomy in 2025 after a biopsy misdiagnosed aggressive endometrial cancer. Post-surgery tests showed no cancer and DNA testing later revealed the tissue belonged to someone else. The Clayton County lawsuit seeks more than $10,000 in compensatory damages and accuses Kaiser entities and a senior lab analyst of negligence and chain-of-custody failures.
Lilly widens early-access for unapproved obesity drug retatrutide
Eli Lilly says it will allow more patients to apply for pre-approval access to retatrutide, the unapproved obesity drug, after previously granting access to a single 79‑year‑old patient; the company is reviewing requests from doctors in line with FDA guidance.
Advisory panel backs Replimune’s RP1 for melanoma despite data questions
An FDA advisory committee voted 10-3 in favor of Replimune’s RP1 oncolytic virus (with Opdivo) for advanced melanoma, citing signs of efficacy despite significant trial-design concerns that the FDA flagged (no control arm, RECIST deviations, reinjection artifacts). While some data hint at systemic activity, the panel stressed uncertainty and noted the ongoing Ignyte-3 phase 3 data as pivotal; the FDA decision on RP1 is expected by August 2 amid a large unmet need for refractory melanoma treatments.
Medicare’s $50 Wegovy Copay Starts July 1, But Eligibility Is Very Narrow
Starting July 1, 2026, Medicare will offer Wegovy and other GLP-1 weight‑loss drugs for a $50 monthly copay through a temporary GLP‑1 Bridge outside Part D that runs through December 31, 2027. Eligibility is tightly restricted by BMI and comorbidities and requires Part D enrollment; those with type 2 diabetes, sleep apnea, or certain liver diseases are excluded and must pursue Part D coverage instead. The $50 copay is outside Part D and does not count toward deductibles or the $2,100 out‑of‑pocket limit. Beneficiaries should verify their plan, gather medical documentation, and work with a clinician to determine if they meet the three eligible tiers.
Mold, Misinformation, and the Fight for Tenant Health
An investigative essay tracing a mold outbreak in a Brooklyn rental to show how MAHA-influenced wellness culture converts mold illness into a political issue. It contrasts the author’s personal symptoms and online detox narratives with landlord neglect and broader housing failures, arguing that mold is best addressed through tenant organizing and housing policy rather than profit-driven detox schemes.
Defining medical AI superintelligence: a call for task-based benchmarks
Researchers argue for a rigorous, task-based framework to define and measure medical AI superintelligence, contending that current benchmarks are misleading and insufficient for evaluating AI performance, safety, and reliability in medicine.
Lilly’s triple-hormone obesity drug achieves major weight-loss results but unclear on heart risk
Eli Lilly’s retatrutide (GIP/GLP-1/glucagon triple agonist) met primary endpoints in two Phase 3 TRIUMPH trials, delivering about 21–23% weight loss at 80 weeks with the 12 mg dose vs ~3.2% for placebo (TRIUMPH-2: 20.8%; TRIUMPH-3: 22.6%). However, cardiovascular risk reduction was not clearly demonstrated, and GI side effects were common (diarrhea, nausea) with higher discontinuation rates. Lilly plans FDA submission in Q1 2027 and frames retatrutide as potentially applicable to obesity, knee osteoarthritis pain, and sleep apnea, though analysts warn the market could be niche and tolerability may limit use.
Cyclosporiasis outbreak swells to 11,000-plus suspected US cases, lettuce clusters under FDA probe
US health officials report over 11,000 suspected cyclosporiasis cases this year, with the CDC tallying 4,173 confirmed across 41 states; Michigan and Ohio account for the bulk of new cases, North Carolina and Indiana above 500, and Kansas over 280, as the FDA investigates five outbreak clusters, including one linked to Taylor Farms lettuce. Many cases go unreported and the illness typically peaks May–August.