| Today’s Big NewsMar 6, 2025 |
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Tuesday, March 11, 2025 | 11am ET / 8am PT In the world of clinical trials, where precision and compliance are critical, the role of technology is more important than ever. Join us to learn how to harness the latest innovations for driving efficiencies and more streamlined experiences for patients. Register now to take a deep dive into the most pressing challenges in clinical trials today! 
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| By Zoey Becker If confirmed, Johns Hopkins surgeon Martin Makary, M.D., would take the reins at the FDA as the agency undergoes cost-cutting measures from the Trump administration. |
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By Conor Hale Awaiting confirmation to become FDA commissioner, Makary also fielded questions from senators on the agency's recent layoffs and its cancellation of vaccine meetings. |
By Nick Paul Taylor One of Merck KGaA’s leading immunology assets has flunked a phase 2 lupus trial. Despite the primary endpoint miss, Merck has concluded (PDF) further development is warranted in light of responses seen in subgroups and a recent win in another form of the disease. |
By Angus Liu Both Merck & Co. and Halozyme are holding their ground in a freshly unveiled patent dispute surrounding the New Jersey pharma’s under-the-skin version of its blockbuster cancer drug Keytruda. |
By Gabrielle Masson A federal judge has blocked the Trump administration’s effort to slash National Institutes of Health grant payments amid ongoing litigation. |
By Eric Sagonowsky Moderna sued Pfizer and BioNTech over three patents protecting its COVID-19 work back in 2022. Now, a U.S. administrative body has ruled that two of those patents are invalid. |
By Gabrielle Masson Under President Donald Trump’s administration, the Department of Government Efficiency has reportedly terminated leases for at least 748 federal sites, including 30 FDA facilities across 23 states. |
By Kevin Dunleavy After reviewing additional clinical data, England's drug-price watchdog NICE has slapped down Eli Lilly's Kisunla and Biogen and Eisai's Leqembi for a second time, after both were approved by the U.K.’s MHRA. |
By James Waldron Zymeworks has pumped the brakes on plans to take one of its antibody-drug conjugates into the clinic so it can prioritize another candidate. |
By Conor Hale Leslie Oley Wilberforce will take the helm from co-founder Christine Lemke, who will stay on as an advisor and member of the board. |
By Fraiser Kansteiner While the ebb and flow of mpox outbreaks may have taken a toll on Bavarian Nordic’s 2024 sales performance, the year also validated, in large part, the travel vaccines business the Danish company has been building out since the start of the decade. |
By James Waldron Denali Therapeutics’ amyotrophic lateral sclerosis drug has racked up another clinical miss this year, leaving the company to mull the asset’s future. |
Fierce podcasts Don’t miss an episode |
| This week on "The Top Line," we hear from Steven McCarroll, Ph.D., whose research team at the Broad Institute of MIT and Harvard recently uncovered new insights into the cause of Huntington's disease. |
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Wednesday, April 9, 2025 | 10am ET / 7am PTLearn 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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