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Wednesday, April 9, 2025 | 10am ET / 7am PT Learn the key steps for successfully entering Japan’s pharmaceutical market. This webinar covers regulatory requirements, compliance strategies, supply chain best practices, and common challenges. Gain expert insights to navigate this high-potential market with confidence. Don’t miss out—register now to secure your spot!
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Today’s Big NewsApr 4, 2025 |
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Wednesday, April 9, 2025 | 11am ET / 8am PT Health systems around the globe face a difficult paradox: delivering more care with fewer resources. In this exclusive webinar, our expert panel will explore how AI-based solutions are addressing these challenges with real-world examples, experience, and published outcomes in ASCO and Nature. Register now.
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| By Fraiser Kansteiner Massive cuts at the FDA have hit staff tied to drug reviews and user fees, putting future approvals in jeopardy, according to multiple reports. |
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By Gabrielle Masson Sixteen state attorneys general are suing the Department of Health and Human Services and the National Institutes of Health over research grant terminations. It's the second major lawsuit challenging the funding cancellations filed against the agencies this week. |
By Conor Hale In a webinar hosted by the medtech development service provider NAMSA, the former long-time chief of CDRH, Jeff Shuren, M.D., said the loss of 3,500 full-time positions through the agency’s recent reduction-in-force would assuredly impact the pace of its work. |
By Darren Incorvaia Sangamo Therapeutics has secured a licensing deal with Eli Lilly that helps extend the cash-strapped company’s runway. Lilly will pay Sangamo $18 million upfront for the rights to use Sangamo’s neurotropic adeno-associated virus capsid to develop a genomic treatment for a central nervous system disease, Sangamo announced on April 3. |
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Thursday, April 10, 2025 | 11am ET / 8am PT Cell and gene therapies offer hope for previously untreatable diseases, with viral vectors currently favored as the primary gene delivery method. However, the complexities pose key challenges. In this webinar, learn how to choose the right production platform for achieving commercial timelines and managing manufacturing costs. Register now.
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By Kevin Dunleavy President Donald Trump’s announcement on Wednesday that pharmaceuticals imported to the U.S. would be exempt from tariff payments brought a sigh of relief from major drugmakers. But at the same time, industry leaders are bracing for the news that they think is inevitable given Trump’s declaration in February to impose “25% or higher” levies on imported drugs. |
By Noah Tong,Dave Muoio,Emma Beavins After sending out termination notices to 10,000 more HHS workers, some are being told their positions shouldn't have been eliminated. |
By Angus Liu As the RSV vaccine field grapples with a significantly reduced market size thanks to regulatory uncertainties, GSK and Pfizer have decided to lay to rest their patent feud. |
By Darren Incorvaia,Zoey Becker As the Department of Health and Human Services grapples with the fallout of mass layoffs directed by Secretary Robert F. Kennedy Jr., top leadership at several agencies is on the outs. |
By Darren Incorvaia Brown University has become the fifth university to be targeted by the Trump administration for funding cuts, according to reports, joining Ivy League peers Harvard University, Princeton University, Columbia University and the University of Pennsylvania. |
By Gabrielle Masson,Darren Incorvaia As always, if you know of layoffs occurring at a biotech, please reach out to the Fierce Biotech editorial team. |
By Conor Hale The NightOwl, about the size of a quarter, is worn on the user’s index finger to record sleep data for up to 10 nights. |
By Andrea Park Funnyman Kenan Thompson is opening up about the not-so-funny experience of living with gastroesophageal reflux disease. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," we dive into our special report ranking the top pharma R&D budgets for 2024. |
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Antibody-drug conjugates (ADCs) and radioisotope therapies (RITs) offer targeted therapies that effectively attack tumor cells while minimizing harm to surrounding healthy tissue. However, the right design of ADC and RIT trials is critical. Access this report to learn about the pivotal role of advanced medical imaging. Download here.
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| ResearchWe interviewed 15 biopharma leaders on the critical success factors for building a Best Practice customer-facing organization. This report shares what we learned. Presented by Blue Matter, strategic consultants in the life sciences |
| WhitepaperRead about four trends that will shape the innovations, therapies, & market landscape in oncology during 2025 & beyond. Presented by Blue Matter, strategic consultants in the life sciences |
| WhitepaperDiscover how to revolutionize your vaccine trials with Avacare's latest white paper. Gain exclusive access to innovative, data-driven recruitment strategies that ensure diverse, efficient, and high-quality vaccine trials. Sponsored by: Avacare Clinical Research Network |
| WhitepaperDevelop your CAR molecule faster Sponsored by: Cell Signaling Technology |
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