| Today's Big NewsDec 7, 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 Fraiser Kansteiner In an investigator-initiated phase 2 study of Enhertu in neoadjuvant HER-2 low breast cancer, just one patient achieved the trial's “tried and true” pre-surgery endpoint of pathologic complete response, Daiichi’s clinical oncology chief Mark Rutstein said in an interview ahead of the 2022 San Antonio Breast Cancer Symposium. |
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By Annalee Armstrong Pfizer is rushing to get its RSV vaccine out the door and into arms. A priority review from the FDA will certainly help. |
By Dave Muoio Per a new report from the American Hospital Association, the average hospital length-of-stay has increased by 19.2% from 2019 to 2022 as well as by nearly 24% for patients being discharged to a post-acute care provider. |
By Conor Hale The agency cleared the University of Oxford spinout’s EchoGo solution to help diagnose heart failure with preserved ejection fraction, or HFpEF. |
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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 Kevin Dunleavy On ICER’s annual list of drugs that had unjustified price increases in 2021, Bausch’s Xifaxan and Johnson & Johnson’s Invega Sustenna caused the most additional spending in the U.S. The treatments displaced Humira as the top offender in 2020. |
By Annalee Armstrong It’s been a year since Avrobio suffered a blow to its gene therapy ambitions with the failure of a Fabry disease program. Now, the biotech is ready to reintroduce itself to investors with a small positive dataset for its new No. 1 priority and the go-ahead from the FDA to advance the clinical program in a rare disease. |
By Andrea Park After months of lead-up, Carla Kriwet, Ph.D., spent only a few weeks at the helm of Fresenius Medical Care. |
By Robert King CMS issued a proposal rule to implement electronic prior authorization by 2026 for Medicare Advantage, ACA and Medicaid managed care plans, replacing a 2020 rule that was withdrawn. |
By Fraiser Kansteiner In the world of CDMOs, good manufacturing practices are sacrosanct. Now, less than a year after EuroAPI’s launch, Sanofi’s drug ingredients arriviste is getting a firsthand lesson in what to do when those processing standards lapse. |
By Nick Paul Taylor Neurocrine Biosciences’ $45 million rare pediatric epilepsy bet has fallen at an early clinical hurdle. Thirty months after licensing the selective T-type calcium channel inhibitor, the biotech has reported its second setback in quick succession with the failure to beat placebo in a small phase 2 clinical trial. |
By Andrea Park Less than a week after announcing that it’s actively exploring a possible sale, merger or other “significant transaction” to help stay afloat, Titan Medical has taken some cost-cutting measures to tide itself over. |
By Anastassia Gliadkovskaya Co-led by IHI and the American Medical Association, the Rise to Health Coalition is seeking industry partners including payers, providers, pharma and biotech companies. They plan to address inequities through shared solutions and actions. |
By Gabrielle Masson On the heels of a failed phase 2/3 study, Lysogene has suspended trading of its shares and is seeking potential partnerships and investors in an effort to stay afloat. |
Fierce podcasts Don't miss an episode |
| This week on "Podnosis," we talk about how biosimilars have the opportunity to make a dent in healthcare costs. We also discuss ways to improve healthcare services in rural areas of the U.S. |
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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 |
Whitepaper Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation. Sponsored by: Thermo Scientific Production Chemicals and Services |
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 |
Whitepaper Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more. Sponsored by: Catalent |
Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored By: Catalent |
Whitepaper Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent Biologics |
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 |
Whitepaper Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
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