The realignment within the U.S. FDA continued with reports of the removal of two high level executives. When asked by BioWorld if the Center for Biologics Evaluation and Research’s (CBER) Office of Therapeutic Products director and deputy director had been forced out and if so, why, an HHS spokesperson responded on background with a single sentence: “Center directors deserve to be supported by managers that are aligned with aggressive goals to expeditiously advance therapeutics for rare diseases using the gold standard of science.”
To no great surprise, the U.K.’s health technology assessment body has found that the benefits of the first two approved Alzheimer’s disease drugs are too small to justify the costs. Neither Kisunla (donanemab, Eli Lilly and Co. Inc.) or Leqembi (lecanemab, Eisai Co. Ltd.), “demonstrate sufficient benefit to justify their high cost, including the cost of administering them,” the National Institute of Health and Care Excellence (NICE) concluded after an extended appraisal of the two amyloid neutralizing antibodies.
Jyong Biotech Ltd. raised $20 million from its Nasdaq debut June 17 to advance a pipeline of botanical drugs targeting male urinary disorders. The New Taipei City, Taiwan-headquartered company’s shares began trading under the ticker MENS, and closed at $10.11 apiece at the bell, up 34.80% from its listing price of $7.50 per share. Shares had kicked up to $15 at opening, reaching double its offering price.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Alligator, Capricor, CSL, Dyne, Ferrer, Geovax, GSK, Hemogenyx, Tisento.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avata, Escugen, Glykos, Immedica, Intact, Oceanus, Orion, Processa, Sunrock.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acurx, Azitra, Immuneering, Lyell, Mineralys, Spyre, Ventyx.
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