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11 September, 2026 |
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sponsored by
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Stop Searching Through COAs and Batch Records. Start Asking Them Questions.
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| Katalyze digitizes COAs, paper batch records, and PDFs, then creates an ontology tailored to your operation and builds a knowledge graph connecting those records with relevant system data. Your teams can search that knowledge and ask questions in plain language, with every answer traceable to its original source. Built for GxP environments, Katalyze puts fragmented records to work across Yield Optimization, Deviation Investigation, and Raw Material Characterization, with your experts in control. |
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We noticed Moderna's recently-approved flu vaccine was not included in CDC's formal clinical guidance ahead of the upcoming respiratory season. The agency cited "legal uncertainties and inquiries" for why it maintained last year's flu guidance.
The CDC would normally convene the Advisory Committee on Immunization Practices to update its recommendations. But, as we've covered, the outside panel is practically defunct while a lawsuit over its construct plays out. Moderna has tempered expectations for earnings from the flu vaccine, excluding sales from projected revenue for the year. |
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Max Bayer |
Senior Reporter, Endpoints News
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by Zachary Brennan
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California-based drug developer Exelixis submitted new safety and efficacy data on its potential treatment of metastatic colorectal cancer (mCRC) to the FDA. The new data... | |
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by Max Bayer
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A trade group representing generics and biosimilars is warning that the lack of product development could imperil billions of dollars in potential savings. The new... | |
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by Alex Hoffman, Kyle LaHucik, Elizabeth Cairns
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→ As Takeda celebrates a pair of FDA approvals, one of its top execs will be retiring in June 2027. Andy Plump joined Takeda from... | |
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by Kyle LaHucik
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Alzheon, a biotech that has been attempting to treat Alzheimer's with a checkered drug candidate for more than a decade, is plotting a major fundraise... | |
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by ENDPOINTS |
Plus news about Sino Biopharm and AtomVie. Yarrow gets more money: New Haven-based Yarrow Bioscience priceda $150 million offering at $26 per share YARW... | |
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