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Thursday, December 15, 2022 | 11am ET / 8am PT Cell therapy products have amazing potential to treat a wide variety of diseases and vast numbers of patients globally. In this webinar we discuss what these key challenges are, how to approach these challenges and some opportunities available to better the process. Register now. 
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Wednesday, December 14, 2022 | 11am ET / 8am PT In this webinar, we explore the key considerations when scaling late-stage cell therapies and how Catalent’s new commercial scale facilities and customer-centric approach can help get therapies to patients faster. Register now. 
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| By Zoey Becker The clash of the COVID-19 vaccine titans just heated up. In response to Moderna's August lawsuit alleging patent infringement, Pfizer and BioNTech have clapped back with a countersuit, refuting Moderna’s claims. |
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By Gabrielle Masson Vaxxinity’s next-gen COVID-19 booster candidate has hit its safety targets in a head-to-head trial against Pfizer-BioNTech’s, AstraZeneca’s and Sinopharm’s vaccines. The biotech plans to push ahead for approval in several countries. |
By Fraiser Kansteiner Complying with Irish takeover rules, Amgen alerted the London Stock Exchange Friday that “any offer by Amgen for Horizon is, or is likely to be, solely in cash.” Naturally, the company caveated that there can “be no certainty” an offer will materialize. Sanofi too will pitch its bid “solely in cash,” according to a press release sent out Friday. |
By Angus Liu In a potential key battleground for KRAS inhibitors that involves combination with Merck's PD-1 king Keytruda, Mirati's adagrasib appears to be pulling ahead of Amgen’s first-to-market Lumakras in the latest clinical data revelation. But Mirati's stock price still tanked. |
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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 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 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 Andrea Park After months of lead-up, Carla Kriwet, Ph.D., spent only a few weeks at the helm of Fresenius Medical Care. |
By Fraiser Kansteiner Friday, Pfizer said it would plug 1.2 billion euros into its manufacturing site in Puurs, Belgium, just one day after plotting an identical outlay in Dublin, Ireland. In Belgium, where the expansion will occur over the next three years, some projects have already been started, while others are scheduled to begin in early 2023, Pfizer said in a local press release. |
By Ben Adams The U.S. inflammatory bowel disease market is seeing a shift in what drugs patients are offered for their first prescriptions. Doctors appear to be favoring the most recently approved drugs from the likes of Bristol Myers Squibb and AbbVie over older TNF therapies, according to a new report by Spherix Global Insights, a healthcare data consultancy. |
By Helen Floersh Researchers have developed an assay that detects the toxic oligomers that drive Alzheimer’s disease progression. The peptide that makes the test work could one day be used as a treatment. |
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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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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Video Revolutionize your monoclonal antibody (mAb) manufacturing with expert insights. Sponsored by: Gibco |
Multimedia Plan Your ASH’22 Attendance In No Time | Interactive Planner Sponsored by: Ferma.AI, a product of ZoomRx |
Podcast How can Medical Affairs divisions bring greater value to their organizations and practitioners every day? Sponsored by: Medscape Medical Affairs |
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 |
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 |
Whitepaper Accelerating bioproduction towards high performance and scale Sponsored by: Capgemini Americas Inc. |
Whitepaper Electronic health records (EHR) and patient registries are both important sources of real-world evidence – but which is right for your needs? Sponsored by: Veradigm Health |
Executive Summary Readers will learn manufacturing by Design Builds on Quality by Design, De-risking the Tech Transfer Process, and more. 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 |
eBook Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored By: Catalent |
eBook Download now to learn about the benefits of transitioning from intravenous to subcutaneously administration, the advantages of using prefilled syringes, and explore challenges and solutions for transitioning from vials to prefilled syringes. Presented 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 |
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 |
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