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Wednesday, November 20, 2024 | 11am ET / 8am PT Join us for a deep dive into electronic Clinical Outcome Assessment (eCOA) systems. We'll explore the latest trends and strategies tailored for increasingly complex clinical trial environments. Learn about the current and future state of eCOA technology, potential areas for enhancement, ways to leverage effectively, and more. Register now.
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Today’s Big NewsNov 14, 2024 |
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De-risk clinical trials with Foresight CLARITY’s ultra-sensitive MRD detection. Foresight CLARITY is IUO-ready for prospective trials through our CLIA-registered central lab.
Learn more about Foresight CLARITY™️
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| By Fraiser Kansteiner Citing "capacity constraints," Novo Nordisk plans to transition its human insulin—which is currently sold in pens and vials—to vials only. The decision is playing a part in a broader discussion around equitable access to diabetes treatments in less-wealthy countries. |
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By Fraiser Kansteiner Gilead will lay off 72 staffers in Seattle, the company confirmed Thursday. Gilead’s lone Seattle office, which the company is also closing down, focuses on “supporting research and clinical development," according to Gilead's website. |
By Angus Liu Upon reexamination, the EMA has made a U-turn on Eisai and Biogen’s Alzheimer’s disease drug Leqembi. But the recommendation for approval has a restriction. |
By Ben Adams For the past three years, biotechs and pharmas have renamed, rebranded and more in a bid to refresh their corporate appeal. |
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Wednesday, November 20, 2024 | 11am ET / 8am PT Join us to discover how to overcome challenges, and learn about practical solutions for scalability and safety in cell therapy manufacturing. Don't miss out, register today.
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By Nick Paul Taylor Merck & Co. is paying $588 million upfront to defend its Keytruda kingdom. The outlay, plus up to $2.7 billion in milestones, has secured Merck global rights to LaNova Medicines’ PD-1xVEGF bispecific antibody. |
By Zoey Becker The gene therapy has already been approved to treat AADC deficiency in Europe and the U.K., among other countries, where it's branded as Upstaza. |
By Nick Paul Taylor Bristol Myers Squibb has linked its CD19-directed CAR-T cell therapy to sustained clinical responses in people with systemic lupus erythematosus, providing further evidence that the emerging class of candidates can reset the immune system. |
By Nick Paul Taylor A strand of Merz Pharmaceuticals’ star-studded promotion of the anti-wrinkle drug Xeomin has landed it a reprimand from the FDA. The agency sent an untitled letter after finding fault with how the company and one of its celebrity spokespeople handled the risks and benefits of the drug in an Instagram reel. |
By James Waldron The clock is ticking for Kronos Bio after the biotech discontinued its last remaining clinical-stage asset over neurological adverse events. |
By Conor Hale The FDA's de novo clearance brings afib screening to a wearable device with a most familiar form factor. |
By Andrea Park As the rollout of its recently launched pulmonary arterial hypertension drug Winrevair ramps up, Merck is continuing its work to improve awareness of and education around the rare disease. |
By Darren Incorvaia Gene therapy for some diseases, including Duchenne muscular dystrophy, can be tricky because the needed gene is often too large to fit inside the viral vector used for delivery. Researchers at the University of Rochester have now taken advantage of a basic cell biology discovery to deliver therapeutic muscular-dystrophy-related genes to mouse cells in two pieces, which the cells can then stitch together into a functional gene. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," we take a closer look at this year’s biotech graveyard, which tracks biotechs that have closed or are winding down. |
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Gene therapy holds the extraordinary potential to transform global health care, boasting a pipeline that has grown tremendously through the years. Download the QPS white paper for insights into the regulatory landscape for future cell and gene therapies.
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| 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 |
| 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 |
| WhitepaperThis e-book explores 7 factors that are critical to the success of emerging biopharma companies, whether they plan to out-license, partner, or launch & commercialize products. It’s an essential resource for emerging companies with products in all stages of development. Sponsored by: Blue Matter |
| WhitepaperUnlock the secrets to faster, cost-effective biologics production with intensified biomanufacturing – download the whitepaper and power up your bioprocessing game! Sponsored by: Syngene International Ltd. |
| WhitepaperDiscover how independent adjudication can safeguard your clinical trials from misidentified adverse events and enhance the credibility of your results. Sponsored by: WCG |
| 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 |
On Helix Date: 4 July 2024 - Location: Babraham Research Campus, Cambridge UK |
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