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Combining the industry-leading GPEx®️ cell line development with streamlined drug substance manufacturing.
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Today’s Big NewsDec 20, 2024 |
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Just secured round from NVIDIA & Accel, Nebius is revolutionizing Life Sciences and Healthcare with powerful GPU Cloud. Cutting-edge AI/ML solutions, competitive pricing, and expert architectural support for breakthrough research. Learn more.
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| By Nick Paul Taylor A phase 3 trial of Novo Nordisk’s next-generation obesity prospect CagriSema has failed to achieve the level of weight loss targeted by executives, prompting investors to wipe 19% off the value of the Danish drugmaker. |
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By Gabrielle Masson The FDA has denied Zealand Pharma’s approval bid for glepaglutide—a possible challenger to Takeda’s Gattex—in short bowel syndrome, citing a lack of evidence. |
By Gabrielle Masson Pyxis Oncology is shelving a clinical-stage monoclonal antibody to focus on its lead antibody-drug conjugate after sharing preliminary results for the candidate last month. |
Sponsored by Inventus Discover how the Inventus Connect eSIM solutions, designed specifically for provisioned devices in clinical trials, are contributing to better patient outcomes with the only seamless global connectivity solution for eCOA. |
By Gabrielle Masson As Cytokinetics’ aficamten awaits approval decisions from regulators in the U.S. and China, Sanofi has picked up China rights to the cardiovascular candidate. |
Sponsored by NVIDIA Even though AI-designed drugs aren’t yet a household term for FDA-approved, commercially available therapies, they are a reality in clinical development pipelines. |
By Darren Incorvaia To develop RNA medicines targeting a proprietary bundle of tumor antigens, Epitopea is tapping nucleic acid delivery specialist Genevant Sciences in a deal worth up to $123.5 million. |
By Zoey Becker However, the combination of Merck's approved doravirine and investigational islatravir didn't prove superiority over Gilead's top-selling Biktarvy in one of the studies. |
By James Waldron Idorsia’s plans to sell its hypertension drug Tryvio have faced a speed bump, even as the biotech plows ahead with around 250 layoffs. |
By Nick Paul Taylor Aadi Bioscience has rebooted its operations, transforming from a commercial business into a preclinical biotech by offloading its approved product and licensing antibody-drug conjugates for $44 million upfront. |
By Darren Incorvaia,Zoey Becker After less than a year on the job, the FDA’s principal deputy commissioner, Namandjé Bumpus, Ph.D., is leaving her post at the end of the year, according to an internal agency email reviewed by Fierce Biotech. |
By Ayla Ellison,Heather Landi This week on "The Top Line," we bring you a special conversation from earlier this month at our New York City gala, where we celebrated this year’s Fierce 50 honorees. |
By Angus Liu Merck in-licensed a preclinical oral GLP-1 candidate from China's Hansoh Pharma. Astellas doubled down in gene therapy with a viral capsid deal with Sangamo Therapeutics. Betta Pharma's Ensacove became the first innovative targeted lung cancer med developed by a Chinese company to win FDA approval. And more. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," we bring you a special conversation from earlier this month at our New York City gala, where we celebrated this year’s Fierce 50 honorees. |
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Wednesday, January 15, 2025 | 11am ET / 8am PT Discover how next-gen Protein A resins and multi-column chromatography can help biomanufacturers optimize costs, enhance purification efficiency, and improve productivity. Learn practical strategies and explore real-world case studies showcasing advanced solutions for scalable, high-throughput processes. Register now.
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| WhitepaperWe interviewed 14 R&D biopharma leaders on the critical success factors for building a Best Practice R&D organization. This report shares what we learned. Presented by Blue Matter, strategic consultants in the life sciences |
| WhitepaperExplore the robust cross-platform agreement between scRNA-seq and bulk RNA-seq, ensuring consistent and reproducible data on immune cell presence. Sponsored by: IQVIA Laboratories |
| WhitepaperThe use of prefilled syringes to administer biotherapeutics is beginning to gain traction because they offer a range of stability, efficacy, and patient safety benefits. Download this white paper to learn how Lonza has developed a novel workflow to ensure confidence regarding functionality in PFS and autoinjectors. Presented by Lonza |
| WhitepaperLearn how to evaluate quality documentation to help you select the right raw materials at early decision points for your cell-based manufacturing processes. Presented by: Thermo Fisher Scientific |
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