| Today's Big NewsMay 17, 2023 |
| By Angus Liu Citing a long list of safety risks and the practical hurdle for patients to undergo a liver biopsy, the FDA said it “cannot justify OCA use in NASH subjects with stage 2 or 3 fibrosis.” |
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By Andrea Park Elizabeth Holmes’ last-ditch effort to avoid prison time while appealing her fraud convictions was denied this week, paving the way for her 11-year sentence to begin. |
By Annalee Armstrong Fierce Biotech's M&A Tracker, your one-stop shop for dealmaking in the biopharma universe. |
By Zoey Becker Joining Allergan's Juvederm brand is Skinvive, which smooths facial skin via hyaluronic acid intradermal microdroplet injection, according to the company. |
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Tuesday, May 23, 2023 | 12pm ET / 9am PT Join us for this insightful webinar to explore why analytical development is often underestimated, and should go hand-in-hand with process development when addressing clinical and commercial manufacturing requirements, advantages of using integrated analytical services within the areas of process development and technology transfer, and more. Register now.
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By Annalee Armstrong The FDA seems to be satisfied that Pfizer's RSV vaccine is safe and effective for administration in pregnant women to protect infants from severe disease. |
By Andrea Park Amid a period of rapid growth for Intuitive Surgical, the robotics maker is also expanding its power structure. |
By Kevin Dunleavy News of the Federal Trade Commission (FTC) lawsuit challenging Amgen’s $28 billion buyout of Horizon prompted an immediate question: Will the U.S. antitrust enforcer also attempt to derail Pfizer’s plan to acquire Seagen for $43 billion? Analysts at Berenberg Capital Markets say don’t automatically assume that Pfizer-Seagen will face the same hurdle. |
By Nick Paul Taylor DeepIntent and Roku want to challenge the idea that watching TV on streaming services is the preserve of the young. With 79% of people aged 50 and up using the services, adults in the core demographics for many drug products are streaming and open to viewing ads. |
By Nick Paul Taylor Roche’s BTK inhibitor has hit the mark in a midphase multiple sclerosis trial—and without causing the sort of adverse events that sparked partial holds on Merck KGaA and Sanofi’s rival assets. |
By Andrea Park With a fresh injection of venture funding and a high-profile addition to its board, Moon Surgical is entering a new phase. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we're concluding 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 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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| WhitepaperChatGPT shows promise in drug discovery for information extraction, scientific text authoring, hypothesis prediction, and chemical entity prediction. This whitepaper explores its potential to streamline research, delving into its technology, applications, and limitations. Sponsored by: Elucidata Corp., Cloud SAAS in Life Sciences R&D |
| WhitepaperLearn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties. Sponsored by: Twist Bioscience |
| 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 |
| 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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