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Trinity Life Sciences can partner with you to assess, benchmark, plan and implement. LET’S GO.
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Today's Big NewsMay 17, 2023 |
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Learn how modern software development is driving the future of clinical research and technology, specifically how it is impacting the next generation of IRT. Learn more.
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| 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. |
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By Annalee Armstrong Fierce Biotech's M&A Tracker, your one-stop shop for dealmaking in the biopharma universe. |
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. |
Sponsored by Bridge Bank Venture debt is a type of debt financing obtained by early and growth-stage companies and typically used as a complementary method to equity financing. |
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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 Nick Paul Taylor Takeda has doubled down on KSQ Therapeutics, handing over “double-digit millions of dollars” on day one and committing up to $510 million on the back end to research and validate novel tumor-intrinsic targets. |
Sponsored by Cytel Developing a new life-saving drug or medical device is fraught with challenges. But while challenges often vary from program to program, one in particular is guaranteed: uncertainty. In this article, Dr Kim, CMO at Cytel, discusses the nature and consequences of the uncertainty challenge, as well as the options available to help pharmaceutical and biotechnology companies navigate it. |
By Helen Floersh Scientists have a lead in the ever-more-urgent hunt for antibiotics that can combat multidrug-resistant bacteria—and this one is a throwback. |
By Gabrielle Masson Gene therapy biotech enGene plans to debut on the public market via a SPAC merger with Forbion European Acquisition Corp. |
By Gabrielle Masson Byondis’ plans to get FDA approval have wilted as the agency hands the Dutch company a complete response letter, denying approval for its antibody-drug conjugate treatment for HER-2 positive metastatic breast cancer. |
By Max Bayer A partial FDA hold on Avidity's lead asset has been "eased," the company announced Wednesday. The hold was first placed in September after a serious adverse event was reported in one treated patient. |
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 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 Angus Liu In this tracker, Fierce Pharma will record the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not make the bar for standalone stories, but we think they are still worth mentioning. |
By Andrea Park Amid a period of rapid growth for Intuitive Surgical, the robotics maker is also expanding its power structure. |
Fierce podcasts Don't miss an episode |
| This week on "Podnosis," we discuss how technology can help diagnose neurodevelopmental disabilities in children. We also talk about how insurtechs can be profitable. |
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Whitepaper ChatGPT 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 |
Whitepaper Learn 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 |
eBook Discover 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 |
Research What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how. Sponsored by: CCC |
Whitepaper This 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 |
Research Strategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies Sponsored by: H1 |
Whitepaper How can eConsent provide a more flexible approach to informed consent? Sponsored by: YPrime |
Whitepaper Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
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 |
Whitepaper For 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 |
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 |
Whitepaper Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
Whitepaper How 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 |
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 Planning 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 |
| July 18-19, 2023 | Jersey City, NJ |
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