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What’s in Today’s Brief? (February 9th Preview)
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Lilly snaps up Orna: $2.4B bet on in vivo CAR‑T
Eli Lilly agreed to acquire Orna Therapeutics for up to $2.4 billion to secure the company’s circular RNA platform for in vivo CAR‑T therapies. Lilly said Orna’s lead program, ORN‑252, a CD19‑targeting in‑vivo CAR‑T candidate, is clinical trial‑ready and aimed at B cell‑driven autoimmune diseases. The deal gives Lilly an in‑house route to generate cell therapies without ex vivo manufacturing. Orna pairs engineered circular RNA with lipid nanoparticle delivery to produce durable expression of therapeutic proteins in patients. Lilly positioned the acquisition as a long‑term investment in genetic medicine and in‑vivo cell engineering, joining peers that have recently bought similar platforms to accelerate autoimmune and oncology pipelines.
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Medable unveils Agentic AI... PI oversight in focus
Medable launched an "Agentic AI" product designed to help principal investigators (PIs) manage and assess electronic clinical outcome assessment (eCOA) data. The company says the agent is goal‑oriented, provides context‑aware decision support, and preserves human accountability with explicit roles, permissions, and human‑in‑the‑loop controls, according to Erika Motley, Medable’s director of product management. Medable positions the tool to reduce manual reconciliation burdens at research sites and accelerate PI review and sign‑off in regulated trials. The system is built to support regulatory review rather than passive monitoring, emphasizing investigator oversight while surfacing items needing clinical judgment.
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FDA vows crackdown: mass-marketing of copycat drugs in the crosshairs
FDA Commissioner Marty Makary pledged swift enforcement against companies mass‑marketing unapproved copycat drugs after telehealth firm Hims announced a compounded semaglutide pill claimed to mirror Novo Nordisk’s Wegovy. Makary said the FDA cannot verify the safety or effectiveness of non‑approved drugs and warned companies would face action for unlawful mass compounding. Novo Nordisk filed suit against Hims alleging Wegovy patent infringement and warned the Hims product uses an untested delivery mechanism versus Wegovy’s SNAC technology. Regulators’ statements and Novo’s legal move underline intensifying enforcement and IP litigation risks as GLP‑1 demand draws alternative suppliers and compounding services.
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Waters completes BD deal – acquired diagnostics unit underperformed
Waters Corporation closed its $18.8 billion transaction to combine with Becton Dickinson’s Biosciences & Diagnostic Solutions business, but reported that the acquired unit missed Q4 revenue expectations. Waters said headwinds included weaker diagnostics demand in China, export approval delays tied to a US federal government shutdown, and a mild flu season that reduced point‑of‑care testing sales. BD announced the sale closing as part of a broader portfolio reshape; BD will receive a $4 billion cash distribution from Waters and plans to use $2 billion to cut debt and $2 billion for share repurchases. Waters reorganized into four divisions to integrate the BD assets and flagged targets for growth in instrument replacement, e‑commerce and service attachment.
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Takeda inks multiyear AI pact with Iambic – small‑molecule push
Takeda signed a multiyear collaboration with San Diego AI biotech Iambic to apply generative AI for small‑molecule discovery across oncology, gastrointestinal and inflammation targets. The partnership will see both companies work on undisclosed targets using Iambic’s generative models and Takeda’s target expertise. Takeda research chief Andy Plump framed AI integration as a competitive imperative, saying the winners over the next five years will be companies that fully embed AI across drug development. The deal follows a wave of pharma partnerships aimed at accelerating target selection, design and lead optimization with computational tools.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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