A federal judge in Maine has put the brakes on a pilot program that would have enabled biopharma companies to offer rebates instead of discounts as part of the 340B program beginning Jan. 1, 2026. Judge Lance Walker sided with the American Hospital Association and other plaintiffs and placed a temporary restraining order on the implementation of the 340B Rebate Model Pilot Program that sought to “deduplicate” discounts for drugs chosen by the Inflation Reduction Act’s drug price negotiation program for Medicare. While the Health Resources and Services Administration, an agency within the U.S. Department of Health and Human Services, “is empowered by statue to achieve the de-duplication objective through a rebate model,” Walker wrote in his decision that the “roll out has involved a rather threadbare administrative record that likely fails to consider and reasonably explain the impact of a rebate model on 340B hospitals, who rely on up-front price concessions to stretch few resources as far as possible to serve rural and poor communities.”
China accepts Hutchmed fanregratinib NDA on single phase II trial
Hutchmed (China) Ltd. has moved closer to establishing China’s first domestically developed FGFR-targeted therapy for intrahepatic cholangiocarcinoma, after the National Medical Products Administration accepted its NDA for fanregratinib (HMPL-453) and granted the drug priority review. The NDA is supported by a single-arm, multicenter phase II registration study conducted in China, reflecting the regulator’s increasing willingness to accept streamlined development pathways for oncology drugs targeting high unmet needs.
Investment pays off as Asia shapes global biotech trends in 2025
Asia, led by China, is no longer just following global pharma trends. It is helping to shape them, and for investors, innovators and policymakers, the question is no longer whether to engage with Asia, but how to engage wisely in this new, more complex world. For its part, China is deepening its regulatory reforms of drugs and devices to foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a global pharmaceutical powerhouse.
Obesity efforts dominate dealmaking in 2025
When glucagon-like peptide-1 (GLP-1) receptor agonists entered the market for obesity and overweight indications in recent years, the uptake and enthusiasm drove investor excitement for companies advancing any of the new mechanisms in the space. The year 2025 was no different, with numerous industry players presenting multibillion-dollar offers to either acquire full companies or to license promising candidates, just to get a foothold – or to continue domination – in what is turning out to be one of the most lucrative fields in biopharma history.
2025 marks a breakthrough year for in vivo gene therapies
Gene editing technologies are moving forward in preclinical development with innovative strategies designed to treat diseases at their root and even reverse them. Tools such as base and prime editing are evolving alongside advances in molecular engineered vectors that deliver therapeutic payloads. However, many approaches still struggle to reach target cells or tissues – either they fail to arrive, or their efficacy is low. In vivo therapies face numerous challenges, but despite these hurdles, 2025 has marked a year of remarkable progress.
BioWorld 2025 Year in Review
BioWorld looks back at the year’s biggest news. Find all of our 2025 Year in Review articles here.
Also in the news
Adlai Nortye, Aosaikang, ARS, Biohaven, Biomx, Genmab, Halda, Harbour Biomed, Hutchmed, Indaptus, Innovent, Inovio, J&J, Lannacheng, Mereo, Praxis, Quralis, Tiziana, Tonix, Ultragenyx
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