During its second-quarter financial update, Bagsvaerd, Denmark-based Novo Nordisk A/S said work with the FGF21 analog zalfermin will be discontinued. A phase II study testing the compound in combination with GLP-1 therapy failed to hit the primary endpoint related to liver fibrosis in metabolic dysfunction-associated steatohepatitis (MASH), without MASH worsening. The news represents an incrementally positive development for such competitors as 89bio Inc. and Akero Therapeutics Inc.

US HHS cancels 22 BARDA mRNA vaccine contracts

In another strike against vaccines, the U.S. Department of Health and Human Services (HHS) announced the beginning of the end of mRNA vaccine development under the Biomedical Advanced Research and Development Authority (BARDA). The wind-down announced late yesterday, ironically in the opening week of National Immunization Awareness Month, includes the cancellation and de-scoping of various BARDA contracts and solicitations related to mRNA vaccine R&D. “We reviewed the science, listened to the experts, and acted,” HHS Secretary Robert Kennedy said. “BARDA is terminating 22 mRNA vaccine development investments because the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu. We’re shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate.”

Is APAC ready for precision medicine?

Precision medicine is becoming a reality in Asia Pacific as more targeted therapies are being developed that are tailored to individual patients, offering a potential cure for disease. But is Asia Pacific ready to harness this transformation, and if not, what are the hurdles that need to be cleared? A new report by LEK Consulting examines Asia Pacific’s readiness for what it calls the “Precision Era,” and examines four key biopharma markets in Australia, China, Japan and South Korea. The report includes an advisory committee of 16 Asia Pacific experts using a “whole system benefits modeling” approach. The report assessed data from more than 1,000 clinical trials across four novel technologies: gene therapies, targeted antibody therapies, drug-device combination therapies, and diagnostic technologies.

HHS appoints acting general counsel as FDA chief counsel

The U.S. Department of Health and Human Services (HHS) has dipped into its own ranks to fill the role of FDA chief counsel in giving Sean Keveney the nod for the FDA post, but it is not clear how this office will function going forward. Robert Foster, the previous FDA chief counsel, was shifted to the post of HHS deputy general counsel for food, research and drugs after taking the FDA chief counsel role in February 2025, suggesting tightening department-wide scrutiny over FDA regulation even if the lines of authority seem jumbled.

Subtyping beats a path toward precision medicine in Alzheimer’s

Subtyping is what made precision medicine in cancer a reality. And for successful drug discovery in all its stages, finding subtypes in Alzheimer’s disease is all but imperative. Prior to the approval of the modestly effective Leqembi (lecanemab, Biogen Inc./Eisai Co. Ltd.), Kisunla (donanemab, Eli Lilly and Co.), and the since-withdrawn Aduhelm (aducanumab, Biogen/Eisai), more than a dozen failed phase III clinical trials were all that amyloid-targeting drugs had to show for themselves for decades of effort. And part of the reason is that amyloid-targeting drugs are akin to the chemotherapies of Alzheimer's disease. They target a universal feature of Alzheimer's. But there are many different molecular pathways that end in amyloid plaque formation.

Also in the news

180 Life Sciences, Acadia, Agios, Aicuris, Ardelyx, BMS, Conduit, Crystal, Elicio, Eureka, Everest, Fresenius Kabi, Gilead, HMNC, Iambic, Iris, Kashiv, Kye, Madrigal, Mission, MS Pharma, Ouro, Polpharma, Redwire, Sana, Serb, Shattuck, Silo, Sumitomo, Tango, Urogen, Vertex, Windtree, Y-mabs