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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 5, 2023 |
| By James Waldron In what looks set to be one of the biggest biotech IPOs of the year, Acelyrin has revealed that it’s expecting to raise $540 million to push its immune drug candidates through the clinic. |
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By Kevin Dunleavy Six months after Gilead got a smackdown in the U.S. for its drug to treat hepatitis delta virus, bulevirtide has scored a regulatory win in Europe. The Committee for Medicinal Products for Human Use (CHMP) has given bulevirtide a thumbs up for patients with HDV and compensated liver disease. |
By Andrea Park A year into the rollout of the Omnipod 5 pump, Insulet is still riding high on the automated insulin delivery system’s ever-increasing popularity. |
By Annalee Armstrong If at first you don’t succeed, try again. That’s what NGM Biopharma has done with a previously failed nonalcoholic steatohepatitis (NASH) candidate, in hopes that it could provide some light at the end of a dark time in the clinic. |
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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 Kevin Dunleavy Ahead of a decision from the FDA on a resubmission, Protalix and Chiesi have scored marketing approval in Europe for their challenger to Sanofi's Fabry disease therapy Fabrazyme. |
By Conor Hale Alongside its earnings report for the first quarter of this year, the company said it aims to start saving between $17 million and $20 million annually by paring back its global operations “across all regions, functions and levels." |
By Kevin Dunleavy After another round of hearings in Johnson & Johnson’s attempt to use a Texas Two-Step bankruptcy strategy for talc litigation, federal Judge Michael Kaplan has ordered the company and those opposing the move to conduct settlement talks, Bloomberg reports. |
By Nick Paul Taylor AstraZeneca is rowing back from its bet on oncolytic viruses. Four years after stepping up its presence in the immuno-oncology field through a five-asset pact with Transgene, the Anglo-Swedish drug developer has scrapped the partnership before moving a candidate into the clinic. |
By Andrea Park Already under fire for other aspects of its animal testing program, Neuralink is in the hot seat once again, this time for a Reuters report on potential conflicts of interest tied to the oversight board governing the animal research program. |
By Annalee Armstrong Boehringer Ingelheim is heading out into the surf with Australia's Kinoxis Therapeutics in a $181 million biobucks deal to develop therapies for neuropsychiatric disorders. |
By Zoey Becker,Angus Liu,Fraiser Kansteiner,Eric Sagonowsky,Kevin Dunleavy After more than three years, the World Health Organization said COVID-19 no longer represents a global health emergency. Plus, CDC director Rochelle Walensky is stepping down. |
By Teresa Carey This week on "The Top Line," we're continuing our miniseries on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription. |
Fierce podcastsDon't miss an episode |
| This week on "The Top Line," we're continuing our miniseries on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription. |
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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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