Food and Drug Administration Commissioner Marty Makary has announced plans to update the regulation of pharmaceutical advertising in the US in order to prevent deceptive messages being sent to patients by developers. On 9 September, the agency issued warning letters to pharmaceutical companies to remove misleading advertisements. Approximately 100 cease-and desist letters were sent to companies judged to have issued misleading ads.
Genmab A/S has received a ‘breakthrough therapy’ designation from the US Food and Drug Administration for an antibody-drug conjugate (ADC) which is in development for endometrial cancer and has shown promising activity in heavily pre-treated patients. The designation was announced on 26 August, just weeks after the company presented new data at the 2025 American Society of Clinical Oncology annual meeting in Chicago, US. The drug, rinatabart sesutecan, showed a 50% objective response rate and two complete responses in heavily pre-treated patients with advanced disease.
Switzerland-based Aphaia Pharma AG has started a second Phase 2 trial of a new oral candidate drug for obesity which aims to restore endogenous endocrine balance in individuals with the disorder. The drug is a coated formulation of glucose, which is included on the World Health Organization’s list of essential medicines. It is designed to be released in the small intestine to restore endogenous nutrient-sensing signalling pathways and stimulate the release of hormones that control multiple functions including appetite, hunger, satiety and glucose metabolism.
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