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What’s in Today’s Brief? (February 12th Preview)
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FDA refuses to review Moderna flu shot: agency cites trial design
The U.S. Food and Drug Administration has refused to begin review of Moderna’s mRNA influenza vaccine application, flagging problems with the trial’s control arm rather than safety or efficacy data. Moderna said the agency’s refusal is inconsistent with prior pre‑trial guidance; the company has requested a Type A meeting to clarify next steps. Moderna submitted mRNA-1010 after a global Phase 3 program and regulatory filings in multiple countries. The agency’s letter, signed by Vinay Prasad, director of CBER, said the trial comparator did not represent the “best-available standard of care,” prompting a refusal-to-file action rather than a conventional review. Moderna disputes the interpretation and has publicly challenged the agency’s rationale. The development injects regulatory uncertainty into mRNA-platform vaccine commercialization and may delay U.S. market access even as regulators abroad accept the dossier. Companies developing next-generation or combination mRNA respiratory vaccines will watch the agency’s rationale and the outcome of Moderna’s requested meeting closely.
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BridgeBio’s oral dwarfism drug wins Phase 3 — company eyes approval push
BridgeBio reported that its oral FGFR inhibitor infigratinib met the primary and key secondary endpoints in a pivotal Phase 3 study for achondroplasia, producing statistically significant annualized height velocity gains versus placebo. The company said the drug was generally well tolerated and plans regulatory meetings to discuss filings later this year. The randomized trial enrolled roughly 110 children and recorded height velocity increases of 1.74–2.1 cm/year depending on the analysis. BridgeBio emphasized the oral route and the magnitude of growth benefits compared with the only currently approved injectable therapy, positioning infigratinib as a potential new entrant in a rare-disease market dominated by BioMarin and Ascendis. BridgeBio said it will accelerate development in hypochondroplasia and prepare regulatory submissions; the result adds to a string of recent late‑stage successes that the company says support near-term filings and competitive positioning in pediatric skeletal growth disorders.
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Madrigal inks Ribo siRNA pact — $60M up front, $4.4B in milestones
Madrigal Pharmaceuticals struck a global licensing agreement with Suzhou Ribo Life Science and Ribocure granting Madrigal rights to six preclinical siRNA programs targeting metabolic dysfunction‑associated steatohepatitis (MASH). The deal includes a $60 million upfront payment and up to $4.4 billion in development and commercial milestones, plus tiered royalties. Madrigal plans to pair the newly licensed siRNAs with its approved THR‑β agonist Rezdiffra, aiming to build a multi‑modality MASH portfolio. The company framed the transaction as part of a broader strategy to expand beyond a single product and to bring genetically targeted liver therapies into combination regimens. The transaction follows a series of deals Madrigal has struck to shore up differentiated pipeline assets for MASH and signals continued industry appetite — and large potential payouts — for liver‑directed RNA therapeutics.
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QuidelOrtho waits on FDA for Lex Dx clearance — acquisition conditional
QuidelOrtho told investors that its planned acquisition of UK molecular system developer Lex Diagnostics depends on imminent FDA clearance of Lex’s point‑of‑care PCR Velo system and the agency’s CLIA‑waiver decision. Company executives described FDA review as slower than hoped while multiple device attributes — hardware, software, cybersecurity and usability — are under evaluation. QuidelOrtho announced it would discontinue its Savanna POC molecular system and pivot to acquiring Lex once regulators clear Lex’s swab‑to‑result PCR platform. Management said the Velo system’s higher‑margin molecular testing could improve gross margins after an initially dilutive rollout and that QuidelOrtho expects to launch multiple platforms in 2026 via organic R&D and partnerships. Investors will watch the timing of the FDA decision closely because clearance triggers the acquisition and materially affects QuidelOrtho’s near‑term product roadmap.
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Thermo Fisher links with Datavant: real‑world data joins clinical research
Thermo Fisher Scientific’s PPD clinical research business struck a strategic partnership with Datavant to enable privacy‑preserving linkage of de‑identified patient data across more than 350 RWD partners and 80,000 U.S. hospitals and clinics. The collaboration will layer Datavant’s tokenization technology into Thermo Fisher’s RWD infrastructure to support trial enrichment and evidence generation. The connection aims to let sponsors enrich randomized trials with longitudinal electronic medical record data, improve study design, and accelerate recruitment through better real‑world cohort identification. Thermo Fisher framed the deal as a step toward scalable, privacy‑protected data interoperability for pharmaceutical and biotech customers. The alliance underscores growing demand from sponsors for integrated RWD and trial platforms to reduce development timelines and strengthen post‑market evidence generation.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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