The U.S. FDA’s year-old Commissioner’s National Priority Voucher (CNPV) pilot program played to mixed reviews at the agency’s June 4 listening session intended to get various stakeholders’ perspective on the ultra-accelerated review process being offered to qualifying drugs.
Agios Pharmaceuticals Inc.’s potential $665 million deal for Oscotec Inc.’s cevidoplenib, a phase III-ready oral SYK inhibitor to treat immune thrombocytopenia, marks a new chapter of development focused on cancer therapy resistance for Oscotec, CEO Yoon Tae-young said.
After a major breach of trust when its data were advertised for sale in China, the UK Biobank will now attempt to recall data previously downloaded by legitimate researchers and seek assurances information has been deleted from local servers.
Roche Holding AG has rapidly developed a research-use only molecular PCR test to detect the rare Ebola Bundibugyo virus, to support response efforts amid the ongoing outbreak in the Democratic Republic of Congo and Uganda. The test comes as commentary in The Lancet this week underscored the urgent need for a fit-for-purpose diagnostic test, as it warned that the absence of reliable testing is hampering efforts to ascertain the scale of the epidemic and understand the transmissibility of this strain of Bundibugyo virus.
TRIM21, an enzyme involved in intracellular substrate degradation, can recognize viruses and bacteria that enter the cytosol when they are coated with antibodies. Just as it tags complex molecules for elimination, it can direct these infectious microorganisms to lysosomes through a mechanism its discoverers have termed antibody-directed xenophagy (ADX). Scientists at the Medical Research Council (MRC) Laboratory of Molecular Biology (LMB) in Cambridge, U.K., have identified the genes involved in this antibody-dependent degradation pathway, which acts as an antimicrobial process, and reported their findings in Molecular Cell on June 4, 2026.
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Agilent, Coloplast, Cycle, Hopstem, Orthalign, QT, Reach, Royal, Sotio, Terremoto, Waters, Xenix.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Abbott, Alnylam, Alpha Tau, Astrazeneca, Axsome, Daiichi, Inceptive, Leica, Minimed, Nanodetection, Oligomerix Tolmar.
Clinical updates for biopharma and med tech, including data readouts and publications: Argenx, Cabaletta, JJP, J&J, Kura, Kyverna, Legend, Tenaya, TG, Transcode, Zenas.
Biopharma and med-tech companies raising money in public or private financings, including: Advanced Nanotherapies, Bluejay, Liminatus, Lixte, Medtronic, Mineralys, Nrx.