FDA Launches Operation TrialBlazer to Speed Drug Research After Regenxbio Decision Reversal

The U.S. FDA reversed its decision on Regenxbio's rare-disease gene therapy, with Regenxbio saying the agency indicated existing data could support an accelerated approval application after declining to approve the treatment months earlier.

“Biotech rivalry between US, China intensifies: Poll Scorecard shows China leading in speed and volume, while US dominates in funding and scientific output Beril Canakci 23 June 2026•Update: 23 June 2026 ISTANBUL China is pulling ahead of the US in the speed and scale of clinical trials, while the US still leads in scientific quality, funding and commercial development, according to a new poll on global biotech competition”

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In a separate FDA move, the U.S. Food and Drug Administration said on Monday it is launching a series of measures to speed up drug research under an initiative called Operation TrialBlazer.

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The Reuters Health News Summary also said Merck's bowel disease drug tulisokibart met the main goal and key secondary goals in a late-stage trial at 12 weeks, showing clinical remission in symptoms of ulcerative colitis.

On the public-health front, Inghams Group implemented a complete lockdown across all of its Western Australian farms and processing operations after Australia reported a second case of the highly pathogenic H5N1 bird flu, and Agriculture Minister Julie Collins said a migratory seabird known as a northern giant petrel tested positive after being found sick near Esperance.

The same Reuters brief reported the USDA said the number of U.S. cases of New World screwworm has risen to 15 after three more animals tested positive in Texas.

A Cure Innovation Index poll released Monday by the Cure Innovation Index said China is pulling ahead of the US in the speed and scale of clinical trials, while the US still leads in scientific quality, funding and commercial development.

The poll drew on a survey of 117 industry leaders and said China led the US in annual new clinical trial registrations in recent years, while the US maintained a much larger historical base of registered trials overall.

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Cure Innovation Index reported that China's drug regulator recorded a record 5,215 clinical trials registered in 2025, the first time the annual total has passed 5,000 and roughly double the level recorded in 2020.

Seema Kumar, CEO of Cure, said in a statement that "America's challenge is no longer discovery alone" and argued the battleground is translation, the speed and efficiency with which breakthroughs move into development, commercialization, and patient impact.

Kumar added that "If the United States wants to stay ahead," the answer isn't to out-publish China but to fix translational bottlenecks with renewed funding and modernized clinical trial infrastructure.

The Cure survey said 72 percent of respondents believed China's biomedical sector is improving faster than the United States, while 85 percent said the U.S. lead will last 10 years or less.

“"America's challenge is no longer discovery alone”

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Cure's findings also said 74 percent cited declining U.S. federal research funding as the top threat to U.S. biomedical leadership, rather than any single Chinese competitive move.

Vanessa Almendro Navarro, Ph.D., MBA, Chief Commercial Officer, City of Hope, said the coordinated strategy should strengthen the full innovation continuum, from NIH-funded discovery to translational development, national clinical trial infrastructure, domestic manufacturing, resilient supply chains, and global talent.

The survey results were presented in San Diego, California on Monday at the annual meeting of the Biotechnology Innovation Organization, where the Cure poll said China leads in clinical development and supply chain while the US leads in moving experimental products through to large-scale production.

In the same Cure framing, Alex Zhavoronkov, PhD, CEO, Insilico Medicine, said, "When it comes to saving lives and curing diseases, there should be no competition, only cooperation," while adding that competing with China requires local presence and competing in China.