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Tuesday, December 5, 2023 | 1pm ET / 10am PT Join us to learn more about what impact deep engineering engagement and an enterprise-grade cloud platform can provide and how a leading life science organization is incorporating AI to accelerate its initiatives. Register now.
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Today’s Big NewsNov 20, 2023 |
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Decemeber 5, 2023 | The Edison Ballroom, NYC A celebration of the 50 key players, changemakers and innovators across biotech, pharma and healthcare. The Fierce 50 is a groundbreaking project to identify, elevate and celebrate the individuals and companies driving advancements in medicine, fostering innovation and shaping the future of biopharma and healthcare. Register Now!
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| By Nick Paul Taylor Bayer’s plans to turn asundexian into a $5.5 billion a year medicine have taken a hit. The factor XIa inhibitor had “inferior efficacy” to Bristol Myers Squibb and Pfizer’s Eliquis in a phase 3 trial, prompting Bayer to stop the study early while continuing to advance the asset in another indication. |
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By Andrea Park Labcorp is planning to lay off dozens of workers from a New Jersey facility by next spring, according to a recent filing with the state’s labor department in accordance with the federal Worker Adjustment and Retraining Notification Act. |
By Fraiser Kansteiner In a letter sent to Sanofi and AstraZeneca, Sen. Tammy Duckworth (D-IL) lamented that the drugmakers “seem to have vastly underestimated” the amount of Beyfortus—also known nirsevimab—needed to protect young kids during this year's RSV disease season. |
By Gabrielle Masson An FDA advisory committee has voted against approving Merck & Co.’s gefapixant, a P2X3 receptor antagonist medicine designed to treat adults with chronic cough. |
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Tuesday, December 5, 2023 | 11am ET / 8am PT Clinical pharmacology information comprises more than 50% of a drug label. Join us for this objective webinar to review the clinical pharmacology-related regulatory hurdles that may lead to review issues or impact approvability of marketing applications, and discuss strategies to mitigate these. Register now.
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By Conor Hale The race is on as Medtronic claims the FDA's second green light in renal denervation this month. The company said it plans to begin the commercialization of its Symplicity Spyral system immediately as it competes with Recor Medical in what's said to be a multibillion-dollar market. |
By Kevin Dunleavy It appears Bristol Myers Squibb’s multiple myeloma cell therapy Abecma will not end the year on a happy note. The company’s effort to gain approval for the CAR-T in an earlier line of treatment—previously set for an FDA decision on Dec. 16—will have to be pushed back pending an advisory committee meeting. |
By Helen Floersh Gene therapy has the potential to dramatically benefit patients with genetic blood disorders but a small study on participants in a clinical trial for sickle cell disease suggests that a key process carried out prior to giving the treatment might cause mutations that make blood stem cells more likely to turn cancerous. |
By Fraiser Kansteiner Bayer is recalling one lot of Vitrakvi oral solution in the U.S. after routine stability testing discovered the presence of microbial contamination identified as Penicillium brevicompactum. |
By Andrea Park For the fourth time already this month, the FDA has issued a notice formally bestowing a Class I label—denoting a heightened risk of serious injury or death—upon a recall of yet another drug delivery device. |
By James Waldron AstraZeneca has launched a new company to allow CROs and fellow Big Pharmas to pay to access its tried-and-tested digital solutions for running clinical trials. |
Fierce podcastsDon’t miss an episode |
| | This episode of "The Top Line" is dedicated to Alzheimer’s disease, spotlighting the latest treatments and what lies ahead. Fierce Pharma's Fraiser Kansteiner discusses Leqembi's full approval with Eisai's Alexander Scott. Annalee Armstrong from Fierce Biotech interviews Alzheimer's expert Howard Fillit, M.D., exploring groundbreaking research. Fierce Pharma’s Eric Sagonowsky speaks with Reisa Sperling, M.D., about Leqembi's potential in preventing Alzheimer’s progression before symptoms emerge. |
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Tuesday, November 28, 2023 | 11am ET / 8am PT Elevate your biopharmaceutical game! Join our webinar to explore game-changing solutions. Uncover the power of Recombumin® rHA – the consistent, animal-free alternative revolutionizing manufacturing. Don't miss this chance to stay ahead in the advanced therapy landscape.
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| WhitepaperAccelerate drug discovery with high-performance computing (HPC) powered by the cloud Sponsored By: AWS, NVIDIA, and Rescale |
| Whitepaper As a leader of technology transfer activities in the industry, Lonza understands the challenges associated with this critical step. Download this White Paper today to learn more. Sponsored by: Lonza |
| eBookEmulate in vivo biology with next-generation in vitro technology. Sponsored by: Emulate |
| Whitepaper A critical area to consider in selecting a CDMO is their ability to successfully complete technology transfers, which involves an intricate set of activities and disciplines that, if done incorrectly, could result in delays and failures that impact the overall success of your end product. Recognizing what it takes to complete this process effectively and efficiently is crucial to selecting the best partner for your project and product needs. This white paper delivers an analysis of critical success factors for effective technology transfer. Sponsored by: Lonza |
| WhitepaperLearn how to develop a high-performing supply chain for cGMP chemicals used throughout your bioprocessing workflows. Sponsored by: Thermo Fisher Scientific Production Chemicals and Services |
| WhitepaperDownload our whitepaper to learn about plasmid DNA design considerations for cell and gene therapy applications. Sponsored by: Aldevron, a GMP manufacturing CDMO of DNA, RNA, and Proteins |
| WhitepaperThis paper explores AI’s potential impact on healthcare and on Medical Affairs (MA) more specifically. It also outlines what MA teams can do now to proactively leverage AI to improve service to their stakeholders. Presented by Blue Matter, strategic consultants in the life sciences |
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