U.S. President Donald Trump’s foreign-imports tariff policies did not hold up well at the Supreme Court, which ruled unconstitutional his edicts under the International Emergency Economic Powers Act. The 6-3 opinion was authored by Chief Justice John Roberts. Dissenting were Justices Samuel Alito, Brett Kavanaugh, and Clarence Thomas.

Japan endorses two iPSC drugs for approval under CEA pathway

Japan is backing conditional approvals of Amchepry (raguneprocel, Sumitomo Pharma Co. Ltd./Racthera Co. Ltd.) and Reheart (Cuorips Inc.), positioning them to become the world’s first induced pluripotent stem cell-derived (iPSC) therapies to receive regulatory clearance. The endorsements come 12 years after Japan revised its legislative framework to accelerate the development of regenerative medicine products, which include cell- and gene-engineered therapeutics. The Pharmaceutical Affairs and Food Sanitation Council’s regenerative medicine subcommittee recommended both products under Japan’s conditional and time-limited early approval pathway after meeting for deliberations Feb. 19.

Grail shares plunge after Galleri test misses primary endpoint

Grail Inc.’s share price dropped more than 50% in premarket trading on Friday after it reported late Thursday that the NHS-Galleri trial did not meet its primary endpoint. The U.K. study, done though the National Health Service (NHS) with 142,000 individuals enrolled, evaluated the ability of Grail’s Galleri multicancer early detection test to look for cancer-specific methylation patterns in blood.

Bioversys tuberculosis combo targets drug resistance

Antibiotics specialist Bioversys AG reported the first clinical proof-of-concept data for alpibectir (BVL-GSK098) in combination with ethionamide in pulmonary tuberculosis, with phase IIa early bactericidal activity data published in the New England Journal of Medicine. Tuberculosis remains one of the leading causes of death from infectious disease globally, with existing treatments becoming less effective due to growing drug resistance. Alpibectir represents a novel resistance-breaking strategy that potentiates the activity of the established antibiotic ethionamide.

Report calls for EU members to pull together on biopharma strategy

Hand wringing over what support Europe’s biopharma sector needs to stay competitive has intensified since the European Commission unveiled its proposal for an EU Biotech Act in December 2025, and the latest contribution to the debate is a comparative analysis of how 10 countries have strengthened their biopharmaceutical ecosystems post-COVID-19. The analysis aims to understand what specific combinations of public investment, regulation and industrial policy are most effective, given the specific conditions in each country, and to assess how different innovation models function.

China tops US in January drug approvals

Worldwide drug approvals in January were led by China, which accounted for 10 of the 35 approvals, or nearly 29% of the total, surpassing the U.S., which typically ranks first in global approvals. The U.S. and Europe each recorded nine approvals, about 26% apiece. One approval each was seen in Canada, France, Ghana, India, Japan, Saudi Arabia and Switzerland.

Also in the news

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