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What’s in Today’s Brief? (February 21st Preview)
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Grail’s Galleri flops in NHS study: shares tumble
Grail reported that its large NHS-Galleri multicancer early detection (MCED) trial failed to meet the study's primary endpoint, triggering a sharp sell-off in the company's stock. The company disclosed topline results showing no statistically significant reduction in combined stage III–IV cancers among screened participants versus controls, though it reported favorable trends in a pre-specified group of 12 deadly cancers. Grail said it will extend follow-up by 6–12 months to let the signal mature and plans to submit more detailed results to ASCO. The trial enrolled 142,000 participants in England and was a key piece of evidence for Grail’s regulatory and reimbursement push in the U.S. and U.K. NHS leaders and regulators will scrutinize whether the study design, population selection, or test performance drove the outcome. Grail management argued the result should not derail ongoing FDA review of its PMA package and said it will press forward with commercial and regulatory efforts. Investors reacted immediately: Grail shares plunged roughly half their value in after-hours trading. The setback reignites debate over MCED clinical endpoints and whether earlier detection via blood-based methylation tests translates into population-level outcome improvements.
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FDA formalizes one-trial default: NEJM authors set new standard
Top FDA officials signaled a formal policy shift: the agency will now default to accepting a single well-controlled pivotal clinical trial as sufficient evidence for drug approval, supplemented by "confirmative evidence." The change was articulated in a New England Journal of Medicine perspective authored by FDA Commissioner Marty Makary and CBER Director Vinay Prasad. Makary and Prasad outlined that confirmatory inputs can include mechanistic data, related-indication results, animal models, or real-world evidence, and that the FDA will retain discretion to require additional trials when warranted. The policy codifies prior agency discretion into an explicit default, potentially reducing late-stage development costs and accelerating approvals. Industry and investors will watch how the new default affects trial designs, statistical expectations, and deal economics. Sponsors may recalibrate development programs, but regulators cautioned exceptions remain for products with unclear mechanisms or surrogate-driven endpoints.
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Moderna’s flu vaccine review reverses course: FDA will now review
Moderna secured a last-minute regulatory reprieve: the FDA reversed an initial Refusal to File and will now accept review of the company’s mRNA influenza vaccine, mRNA-1010, after a Type A meeting. The agency’s earlier concern centered on the trial’s control arm for adults 65+, which CBER said did not reflect U.S. standard-of-care comparators. Moderna proposed an age-stratified regulatory pathway — full approval for ages 50–64 and accelerated approval plus a pragmatic post-approval study for 65+ — and engaged in a focused meeting that cleared the way for review. Company CEO Stéphane Bancel framed the outcome as constructive engagement with regulators. The episode highlights growing friction between sponsors and reviewers over comparator selection and trial design in vaccine submissions, and it underscores political and leadership scrutiny at FDA. The U-turn may influence how sponsors design pivotal vaccine studies going forward.
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Danaher shells out $10B for Masimo — diagnostics consolidation accelerates
Danaher announced a definitive agreement to acquire Masimo for approximately $10 billion in cash, expanding Danaher’s footprint in patient monitoring and diagnostics. The deal values Masimo at $180 per share and is positioned as a strategic move to integrate pulse oximetry and perioperative monitoring into Danaher’s diagnostics and acute-care portfolio. Executives said the acquisition aims to deliver scale and broaden Danaher’s hospital offerings amid rising demand for integrated monitoring solutions. The transaction underscores continued consolidation as larger device and diagnostics firms seek vertical integration and richer hospital data streams. Regulatory clearance and integration plans will be watched closely, as the deal could reshape acute-care device supply chains and influence competitive dynamics in monitoring and perioperative technologies.
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Guardant ramps screening business, buys MetaSight — Shield growth accelerated
Guardant Health projected material screening revenue growth for 2026 and disclosed the acquisition of MCED startup MetaSight Diagnostics for $59 million upfront (plus up to $90 million contingent). The company expects Shield screening revenue to rise to $162–$174 million in 2026 and volumes to reach 210,000–225,000 tests. Guardant said Shield — its FDA-cleared colorectal cancer screening blood test — benefited from growing demand, strong adherence, and forthcoming integrations with major lab networks, including a commercial collaboration with Quest Diagnostics. The MetaSight purchase expands Guardant’s screening portfolio and technology stack for early-detection assays. Management tempered expectations as early-stage launches scale, but positioned the moves as a deliberate push to build a multi-test screening franchise tied to clinical guideline adoption and payer coverage.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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