| Editor's Note: Getting ready for #ASH22? Fierce Pharma will talk to Dr. Naveen Pemmaraju at MD Anderson in a Twitter chat about the latest advances in blood cancer. Search #FierceTalksASH starting at 4pm ET on Dec. 8 to join the conversation. Our team will also be on site in New Orleans to bring you fresh data from the annual conference. |
Today's Big NewsDec 5, 2022 |
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Thursday, December 15, 2022 | 11am ET/8am PT Join Aaron Miri and Amy Huveldt from Baptist Health, Jacksonville to learn how they are scaling disruptive, AI-based technology across the enterprise. During this webinar, Aaron and Amy will share best practices of a successful digital transformation as well as the results they have experienced system-wide. Register Now. 
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| By Dave Muoio Big-name systems like Cleveland Clinic and NorthShore have cracked the seal on charges for certain patient portal queries. Though the new policies drew swift pushback from consumers and transparency groups, a successful rollout could see more provider organizations follow their example. |
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By Nick Paul Taylor Amgen’s late run for the obesity market is gathering pace. In phase 1, recipients of the highest dose of the company’s would-be challenger to Novo Nordisk’s Wegovy maintained double-digit percentage weight loss 150 days after receiving the last of three shots. |
By Conor Hale Each year, we ask for your help in bringing to our attention the companies you believe are the fiercest in medtech. |
By Fraiser Kansteiner Pfizer is throwing down $750 million to upgrade sterile injectables production at its facility in Kalamazoo, Michigan, where the company cranked out some of the earliest COVID-19 vaccines in the U.S. The project is expected to generate 300 new jobs. |
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Thursday, December 15, 2022 |2:00pm ET / 11:00am PT This talk emphasizes the role of partnerships between early- and late-stream analytical assay developers while tackling unique challenges in validating flow cytometric methods for Chimeric Antigen Receptor (CAR) T cells, during manufacturing and clinical monitoring. We will be introducing Critical Quality Attributes and key considerations when designing sample preparation methods, optimization, validation, and implementation for cell and gene therapy bioanalytics. Register now. 
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By Robert King More large employers and unions are relying on Medicare Advantage to offer health benefits to their retirees in a bid to lower healthcare costs, a Kaiser Family Foundation analysis finds. |
By James Waldron With the acquisition of Neogene Therapeutics this week and with a CAR-T now in phase 1 courtesy of a Chinese partnership, AstraZeneca hopes to add the first volumes to a planned “library” of off-the-shelf cell therapies. |
By Kevin Dunleavy With bankruptcy looming for Clovis Oncology, the company has reported in a securities filing that it has defaulted on a loan by failing to make an interest payment. Clovis also revealed that it has decided—at the request of the FDA—to restrict the use of its cancer drug Rubraca to those whose tumors have BRCA mutations. |
By Andrea Park A deep learning model developed by Google's DeepMind division and the U.S. Department of Veterans Affairs incorrectly identified female patients across all levels of acute kidney injury severity, a recent analysis found. |
By Zoey Becker FibroGen is cracking down on former employees accused of trade secret theft. The company filed a lawsuit in the U.S. District Court in the Northern District of California. |
By Paige Minemyer Advocate Aurora Health and Atrium Health have closed their megamerger, the health systems announced Friday. |
By Nick Paul Taylor The FDA has set out its reasons for putting Verve Therapeutics’ high cholesterol gene editing therapy on hold. Officials want additional data to allay concerns that patients could pass on the edited genes to their children before they lift the clinical hold. |
By Andrea Park After Abiomed’s attempts to expand the user pool for its Impella RP heart pump were less than successful, the FDA has updated the wording of the device’s label to direct it toward only the patients who may benefit most. |
Fierce podcasts Don't miss an episode |
| This week on “The Top Line,” we discuss the current state of Biogen and recent investor reactions to the new hire. Plus we cover the week's news including: What Albert Bourla said that has him in hot water, a $3.5 million drug, and we tease a possible major acquisition. |
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This playbook looks at why insolubility is an issue, and the properties that affect solubility, such as the molecule’s structure; its physical attributes (particle size and dissolution rate); its chemical attributes, including compatibility with excipients; and its biological properties. Download now. 
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Video Revolutionize your monoclonal antibody (mAb) manufacturing with expert insights. Sponsored by: Gibco |
Whitepaper Learn how to develop a high-performing supply chain for GMP-manufactured chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific. Sponsored by: Thermo Fisher Scientific |
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Webinar Twist Bioscience CSO Dr. Aaron Sato shares how Twist's tools for antibody discovery have been applied to identify antibodies against diverse and challenging targets. See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions. Presented by: Twist Bioscience |
Executive Summary Strategies to help scale-up for commercial manufacturing are critical to getting cell and gene therapies to patients as more advanced therapies reach late-stage clinical studies and regulatory decisions. Sponsored by: Catalent |
Whitepaper How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent |
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Research Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments. Sponsored by: Catalent |
Whitepaper Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
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