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Thursday, December 7, 2023 | 2pm ET / 11am PT In this webinar, explore proven strategies, technology insights, and practical approaches to drive innovation, ensure data reproducibility, and unlock the potential of the Lab of the Future. Register now. 
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Today’s Big NewsNov 29, 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 Annalee Armstrong As if biotechs needed any more bad news, CAR-T therapy companies are trading down today on the news that the FDA will investigate the “serious risk” of subsequent, secondary cancers that can occur after treatment with the therapies. |
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By Annalee Armstrong Gilead’s Kite Pharma cell therapy unit is undergoing a business review that will result in layoffs to about 7% of the organization’s workforce. In a letter sent to staff this week that was obtained by Fierce Biotech, Kite Pharma Executive Vice President Cindy Perettie previewed a “refreshed business strategy” that would better align the unit’s strategic priorities. |
By Andrea Park As Philips still scrambles to wrap up its 2021 recall of more than 5.5 million home ventilators, a new issue has cropped up among another swath of its CPAP machines. |
By Angus Liu As industry watchers deliberate the implications from the FDA's investigation into secondary cancer risks from CAR-T medicines, an upcoming expert meeting could offer precious clarity from drug regulators. |
By Annalee Armstrong Karuna Therapeutics officially has its date with the FDA. The agency will decide on the approval of KarXT for schizophrenia by September 26, 2024. |
By Zoey Becker After a May inspection, the FDA cited the troubled manufacturer for several instances of data manipulation dating back to 2021, plus a lack of proper managerial oversight. The drugmaker is now on an import alert, with products made at the site considered "adulterated," according to the FDA. |
By Max Bayer Jazz is pausing a phase 1-stage sleep disorder med after clocking concerning side effects in healthy volunteers. Executives emphasized they were not terminating the program outright but needed time to investigate. |
By Andrea Park In much the same way that they’re designed to expand wearers’ upper airways, Vivos Therapeutics’ slate of oral appliances have now expanded their FDA indications, too. |
By Nick Paul Taylor Eli Lilly has joined Prism BioLab’s stable of Big Pharma partners, striking a deal worth up to $660 million to collaborate on the discovery of oral inhibitors of protein-protein interaction targets. |
By Kevin Dunleavy Dermavant CEO Todd Zavodnick isn’t concerned with the slow uptake of hyped plaque psoriasis drug Vtama. He points to another breakthrough treatment which took a while to catch on—Botox. |
By Conor Hale Orthofix has found itself a new leader after the board ousted its previous chief and other members of its C-suite in September over what they described as “offensive conduct.” |
Fierce podcasts Don’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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Thursday, December 7, 2023 | 2pm ET / 11am PT Unlock the secrets to affordable autologous cell therapy manufacturing! Join our webinar to learn about cutting-edge solutions. Discover cost-effective closed-system designs for commercial scale production, bridging the gap between innovation and accessibility. Don't miss out on valuable insights into minimizing expenses in labor, equipment, materials, and facility footprint. Register now. 
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Whitepaper Accelerate 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 |
eBook Emulate 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 |
Whitepaper Learn 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 |
Whitepaper Download 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 |
Whitepaper This 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 |
| Edison Ballroom, New York City |
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