| Today's Big NewsDec 9, 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 Ben Adams You have to double-check that a recent tweet out from Pfizer’s official corporate account was in fact real and not from the slew of imposter accounts set up in recent weeks designed to tweet controversial statements under the guise of an official account. |
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By Annalee Armstrong Cytokinetics will finally get the chance to make the case for its heart failure drug to the FDA's advisory committee next week. But it seems the agency is uneasy about the single study used to support the application and whether that phase 3 test covered some of the company's asks. |
By Heather Landi Deal valuations in 2022 were largely driven by activity in the home health and hospice markets, such as CVS’ acquisition of Signify Health for $8 billion and UnitedHealth's $6 billion deal to buy LHC Group. This sector will continue to be a robust area for investment in 2023, PwC's Nick Donkar said. |
By Andrea Park After serving as Edwards Lifesciences’ chairman and chief executive since its 2000 spinout from Baxter International, Michael Mussallem is stepping down. |
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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 Annalee Armstrong Gilead landed its Kite unit at Arcellx to work on a phase 2 multiple myeloma cell therapy, a deal worth $225 million upfront plus a $100 million equity investment. |
By Fraiser Kansteiner As AstraZeneca and Daiichi Sankyo seek to rewrite the breast cancer playbook, the question is becoming not who should get Enhertu, but who shouldn’t, one exec says. |
By Paige Minemyer Health benefits costs rose by 3.2% this year, and employers are bracing for an even larger hike in 2023, a new survey shows. |
By Andrea Park Two years after striking up a deal to commercialize an automated insulin pump that would be developed and manufactured by Ypsomed, Eli Lilly has called off the partnership. |
By Kevin Dunleavy Senate Finance Committee Chairman Ron Wyden, D-Oregon, is targeting Amgen again about its tax practices, this time making a “final request” of the California biotech to provide information on how it shifts revenue to offshore subsidiaries. In a letter to Amgen CEO Robert Bradway, Wyden asked for “voluntary compliance” and answers to a prepared list of questions by Dec. 21. |
By Frank Diamond The FDA yesterday approved the bivalent COVID-19 booster shot for children as young as 6 months old. There are some caveats, however. |
By Nick Paul Taylor AstraZeneca’s $1 billion bet on Daiichi Sankyo’s TROP2 antibody-drug conjugate delivered promising early-phase breast cancer data. Chasing Gilead, the partners have linked the TROP2-directed ADC datopotamab deruxtecan to response and survival results that suggest they have a shot at coming from behind to disrupt the market. |
By Conor Hale The company and Fruchterman “mutually agreed” that he would leave his positions as president, CEO and member of its board of directors. Fruchterman will stay on through the end of the year to work with the leadership team on the transition. |
By Teresa Carey This week on “The Top Line,” we discuss the latest from the Clinical Trials on Alzheimer’s Disease conference. Plus, we cover the week's news including an investigation into Neuralink, Google’s DeepMind and why things aren't working out for PI3Ks. |
Fierce podcasts Don't miss an episode |
| This week on “The Top Line,” we discuss the latest from the Clinical Trials on Alzheimer’s Disease conference. Plus, we cover the week's news including an investigation into Neuralink, Google’s DeepMind and why things aren't working out for PI3Ks. |
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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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