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8 July, 2025 |
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Be sure to check out Ryan Cross’ story on a startup that’s raised $45 million to work on a universal flu vaccine. Centivax plans to rely on mRNA for its shot despite the Trump administration’s skepticism of the technology, and investors aren’t too worried about politics getting in the way. |
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Alexis Kramer |
Editor, Endpoints News
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by Zachary Brennan
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Thousands of FDA staff departures since April have sparked concerns within the pharma industry that novel drug approval deadlines might slip. But in the first six months of 2025, the approval numbers remain generally aligned with previous years, even as FDA officials warn that the full extent of the staff cuts has yet to be realized. As of July 2, the FDA has approved 24 new drugs and biologics so far in 2025, compared with 36 novel products approved by CDER and CBER over the same time period in 2024, and 40 in 2023. Approval numbers may vary year-to-year, depending on previous years' submissions, and often serve more as a sign of industry productivity and FDA's workload. |
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President Donald Trump at a Cabinet meeting on July 8, 2025 (Evan Vucci/AP Images) |
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by Max Bayer
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President Donald Trump said pharmaceutical companies will have a grace period of at least a year to move their manufacturing to the US before facing tariffs on their drugs. The new detail disclosed Tuesday by Trump came as he promised the tariffs on drugmakers, which have been in development since early this year, would come "very soon." Trump has
repeatedly said over the last few months that the tariffs were coming shortly. A grace period would give companies at least some time to shift manufacturing — though it often takes years to build and bring new drug plants online, far longer than Trump is proposing. |
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by Ryan Cross
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Scientists seeking to make personalized gene editing therapies a reality for more people have launched a new initiative to develop cures for the rarest of diseases left behind by drug companies. The
Center for Pediatric CRISPR Cures, announced Tuesday by the Chan Zuckerberg Initiative, will make custom treatments for children with inherited immune conditions or metabolic diseases. The center is part of the Innovative Genomics Institute (IGI) at University of California, Berkeley and is supported by a $20 million grant from the CZI. The effort builds on the recent success that scientists had in
developing a custom CRISPR therapy for one infant’s debilitating metabolic disease in under seven months, Fyodor Urnov, a gene editing scientist at the IGI who is leading the new center, told Endpoints News. He described that success as a “yes we can” moment for the field. |
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by Nicole DeFeudis
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An Otsuka subsidiary said Tuesday that its experimental therapy for Duchenne muscular dystrophy has failed its Phase 3 primary endpoint in a group of ambulatory patients in Japan. Taiho Pharmaceutical said the study showed “no significant difference” over 52 weeks in patients’ mean change from baseline in the time it takes to rise from the floor, missing the primary endpoint for a cohort of patients who can walk independently. Duchenne is a rare and devastating genetic muscle disease that primarily affects boys and men. The ambulatory cohort enrolled male Duchenne patients 5 years and older who received either Taiho’s oral drug TAS-205 or a placebo twice daily for 52 weeks. Taiho hasn’t released the
full dataset, but said that “detailed results” will be presented at a future academic conference. The company also set out to test TAS-205’s safety in a non-ambulatory cohort, according to the US’ clinical trials registry, but didn’t share information from that group on Tuesday. |
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