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FDA Cleared TAP®️ Micro Select enables remote blood collection with HALO™️ technology, a bladeless micro-needle array delivering virtually painless, large volume collection up to 500 uL. Click now.
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Today's Big NewsMay 4, 2023 |
| By Eric Sagonowsky After FDA inspectors visited Eli Lilly and Rentschler Biopharma production sites in October 2022 and early 2023, respectively, the United States' drug regulator is making concerns about the facilities public. |
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By Annalee Armstrong The KRAS inhibitor scene has always been a bit braggadocious with Amgen and Mirati Therapeutics battling it out for the first-to-market advantage. But now a new crop of scrappy KRAS upstarts has arrived on the medical conference circuit, trying to needle away at the leaders. |
By Andrea Park Just a few months after it began pruning back operations at a trio of its test-making facilities in San Diego, Thermo Fisher Scientific is now completely uprooting all three. |
By Angus Liu Novartis has been busy beefing up Sandoz on the way to spin out the unit into the world’s largest generics company. In a new deal, Sandoz obtained exclusive rights to sell six small-molecule generic candidates in the U.S. from Malta-based pharmaceutical company Adalvo. |
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Thursday, May 25, 2023 | 10:00am ET / 7:00am PT Join the webinar and discover our MVA technology platform and explore the advantages for development and manufacturing of multiple vaccines and cell and gene therapeutics. Register now.
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By James Waldron Three years after the FDA forced Novo Nordisk to pause a trial of its potential Hemlibra rival over reports of blood clots, the U.S. regulator has placed a further barrier in front of the drug—even as it secures approval in other territories. |
By Andrea Park On the heels of a first quarter that saw its sales slip and operating loss widen, Tandem Diabetes Care is banking on making big moves in the second half of the year to turn things around. |
By Zoey Becker After Wegovy's market relaunch in January, Novo Nordisk sees a "short-term need" to limit supplies of certain doses of the obesity medicine in the United States. |
By Nick Paul Taylor Roche is betting preclinical drug development is on the cusp of a major change. After tracking advances in fields including engineering and computational science, the Swiss drugmaker has set up the Institute of Human Biology (IHB) and asked its staff to collaborate with external partners to create better models. |
By Conor Hale A yearslong collaboration between Click Therapeutics and the drugmaker Boehringer Ingelheim exploring the potential of digital apps in schizophrenia therapy will now be put to the test in the clinic. |
By Angus Liu Demand for COVID vaccines is falling fast, and Moderna is feeling the chill. The mRNA biotech expects to generate between $200 million and $300 million sales from its COVID vaccine Spikevax in the second quarter based on existing contracts, a steep decline from prior periods. |
By Annalee Armstrong Pfizer and Valneva are pushing back a regulatory filing for their Lyme disease vaccine by a year after the companies were forced to pull half of the participants from a phase 3 study in February. |
By Conor Hale After collecting an FDA clearance last year for its smartphone-based home kidney test, Healthy.io is letting it be known that it has the cash to help back it up. |
Fierce podcastsDon't miss an episode |
| | This week on "Podnosis," we discuss how the healthcare industry is addressing its role in climate change. |
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Thursday, May 11, 2023 | 2pm ET / 11am PT Medical imaging holds a wealth of valuable data that can power R&D. Join us to learn how to overcome historical challenges such as the need for expertise in the field and a lack of comprehensive tools. We'll explore ways medical imaging data can be utilized in R&D, strategies for organizing and re-purposing legacy data, and more. Register now.
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| eBookDiscover a game-changing approach to clinical research with Hybrid and Decentralized Clinical Trials (DCTs). Learn about the benefits, challenges, and key elements for success. Sponsored by: EvidentIQ |
| ResearchWhat role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how. Sponsored by: CCC |
| WhitepaperThis paper focuses on stakeholder engagement and how Medical Affairs teams’ responsibilities, goals, tools, and techniques are changing. Sponsored by: Blue Matter, strategic consultants in the life sciences |
| ResearchStrategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies Sponsored by: H1 |
| WhitepaperHow can eConsent provide a more flexible approach to informed consent? Sponsored by: YPrime |
| WhitepaperPreparation 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 |
| WhitepaperExplore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
| WhitepaperDiscover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
| Whitepaper As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. Sponsored by: Catalent |
| WhitepaperFor sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. Sponsored by: Catalent |
| WhitepaperLearn 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 |
| WhitepaperHow can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
| WhitepaperPlanning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
| WhitepaperExplore 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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