In today's Pharmaceutical Executive Daily, new Octane study data show patients switching from injectable semaglutide or tirzepatide to Novo Nordisk's oral semaglutide pill lose an average of 4.1% of body weight in three months, FDA's peptide rulemaking stalls even as the agency's enforcement arm cracks down on compounded peptide sellers, and Avi Pardo argues that life sciences compliance programs have a blind spot in the unmonitored texts and messaging apps field teams use with health care professionals.
New data from Novo Nordisk's Octane study show that adults with overweight or obesity who switch from injectable semaglutide or tirzepatide to once-daily oral semaglutide lose an average of 4.1% of body weight, or 8.8 pounds, within three months. The retrospective analysis, drawn from the Ro telehealth platform and presented at the European Association for the Study of Diabetes annual meeting, followed 194 patients with a mean baseline weight of 100.5 kilograms and found the share classified as having obesity fell from 87.1% to 65.5% over that period. Martin Holst Lange, executive vice president at Novo Nordisk, says the company innovates to meet patients where they are, whether the driver is needle anxiety, lifestyle, or preference.
FDA's rulemaking on compounded peptides has stalled even as the agency's enforcement arm moves against sellers who didn't wait for a legal pathway to open. The agency's Pharmacy Compounding Advisory Committee voted in July to recommend six of seven nominated peptides, including BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax, for inclusion on the Section 503A bulks list, but the formal rule has yet to advance, leaving peptide therapeutics caught between two FDA processes moving at very different speeds.
Finally, Avi Pardo argues that life sciences companies spend billions on compliance infrastructure while conversations between field teams and health care professionals on WhatsApp, iMessage, and SMS remain invisible to oversight. Pardo contends that this gap sits in plain sight despite extensive regulatory frameworks already governing drug development, clinical trials, marketing claims, and other HCP interactions.
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