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What’s in Today’s Brief? (May 14th Preview)
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Hengrui and BMS ink large global oncology research pact
Bristol Myers Squibb (BMS) and Jiangsu Hengrui Pharmaceuticals announced a collaboration spanning 13 early-stage programs across oncology, hematology and immunology. BMS will pay Hengrui up to $950 million over two years, including a $600 million upfront payment, with total deal value potentially topping $15.2 billion as milestones and royalties accrue. Under the agreement, Hengrui will oversee early clinical development to drive faster proof-of-concept, while both companies retain specific geographic rights: BMS gets exclusive worldwide rights outside Hengrui’s territory (mainland China, Hong Kong and Macau), and Hengrui retains exclusive rights within those regions for Hengrui-originated assets. The portfolio includes four oncology/hematology assets from Hengrui, four immunology assets from BMS, and five “innovative” assets to be jointly discovered and developed. Executives positioned the pact as a way to combine Hengrui’s discovery engine with BMS’s global clinical and regulatory capabilities.
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Isomorphic Labs closes $2B Series B for AI drug design
Isomorphic Labs, the Alphabet-backed AI drug discovery company, closed a $2.1 billion Series B round led by Thrive Capital, with participation from Alphabet and Google’s GV, plus other global investors including MGX, Temasek, CapitalG and the U.K. AI fund. The funding is slated to expand Isomorphic’s unified drug design engine, IsoDDE, and accelerate its in-house pipeline toward the clinic. The company pointed to prior collaborations where Big Pharma partners tasked Isomorphic with using AlphaFold-based modeling to find small molecules for undisclosed targets. With the round among the largest ever for a biotech startup, the message to the industry is that AI-first discovery companies are still attracting scale capital to move from models to measurable clinical programs.
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FDA leadership shock after Marty Makary’s resignation
Marty Makary resigned as FDA commissioner, with Kyle Diamantas stepping in as acting commissioner. The change ends a tenure that reshaped biotech expectations around drug review processes, including initiatives aimed at speeding development and adopting AI-assisted approaches, but also coincided with internal upheaval and disputes over guidance. Industry observers highlighted uncertainty created by leadership turnover and acting-role constraints on senior reviewers, raising questions about how quickly current reforms will persist. The abrupt transition is now forcing companies to re-evaluate timelines and engagement strategies with the agency. The immediate focus for biotech stakeholders is whether the next permanent FDA leadership will maintain Makary-era pathways—or alter course on review cadence, scientific depth and rare disease frameworks.
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Regulator signs off on Cepheid’s multiplex GI diagnostic under IVDR
Cepheid received CE marking under the EU In Vitro Diagnostic Regulation (IVDR) for its Xpert GI Panel, a syndromic multiplex PCR test for acute gastrointestinal pathogens. The panel detects 11 bacteria, viruses and parasites from a single stool sample with results in about 74 minutes. The assay runs on GeneXpert systems equipped or upgraded with 10-color technology and requires less than one minute of hands-on time. Cepheid said the test supports clinical decisions in overlapping symptom scenarios and can help guide treatment in higher-risk patients. Cepheid also noted the panel’s prior FDA 510(k) clearance earlier this year, and indicated shipping will begin to countries that accept CE marking in the coming weeks.
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Winship delivers first U.S. in vivo CAR-T dose in multiple myeloma trial
Physicians and researchers at Emory University’s Winship Cancer Institute administered the first investigational in vivo CAR-T cell therapy dose in the United States for relapsed or refractory multiple myeloma. The study targets disease that has progressed after prior treatments, marking a milestone for next-generation cellular approaches designed to avoid full cell manufacturing workflows. The investigational program is positioned as a U.S. first for an in vivo CAR-T strategy—where CAR components are delivered into the patient to enable endogenous targeting machinery rather than ex vivo engineered T-cell infusion. The report frames the dose as a step toward broader clinical validation. For biotech stakeholders, the event underscores how “in vivo” CAR platforms are moving from concept to regulated clinical dosing and expanding the competitive landscape beyond traditional ex vivo manufacturing.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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