• California: Structure Therapeutics last week reported that its daily obesity pill led patients to lose roughly 16% of their body weight after 44 weeks in a Phase 2 trial. In the trial, 85 overweight or obese patients received one of three doses of aleniglipron, Structure's GLP-1 pill, or a placebo. Patients who received the 240 milligram and 180 milligram doses lost 15% and 15.3% of their body weight, respectively, while patients who received the placebo gained 1.1% of their body weight. Currently, Structure said it plans to test the 240-milligram dose in a Phase 3 trial during the second half of the year. According to STAT, the results from Structure's Phase 2 trial suggest that its GLP-1 pill is comparable to the ones developed by major drugmakers like Novo Nordisk and Eli Lilly. Novo launched an oral version of its weight-loss treatment Wegovy late last year, which resulted in an average weight loss of 14% over 64 weeks. Lilly's new GLP-1 pill orforglipron is also expected to be approved soon and resulted in roughly 11% weight loss after 72 weeks. (Mast, STAT+ [subscription required], 3/16)
• Maryland: FDA has launched a new surveillance system to track potential adverse effects associated with drugs, vaccines, and other products. The new Adverse Event Monitoring System will combine information that was previously spread across seven different databases. Currently, the new platform includes data from four systems that monitored drugs, biologics, cosmetics, color additives, vaccines, animal drugs, and animal foods. By the end of May, the platform will also include databases on medical devices, human foods, dietary supplements, and tobacco products. "The FDA's previous adverse event reporting systems were outdated and fragmented and made important data difficult to access," said FDA Commissioner Marty Makary. "These clunky systems also wasted millions of taxpayer dollars and created blind spots in our postmarket surveillance of products ranging from drugs and vaccines to cosmetics." According to FDA, combining all the databases into one system will save the agency $120 million over five years. (Jensen, Biopharma Dive, 3/12)
• New Jersey: J&J has won FDA approval for a first-of-its-kind psoriasis pill called Icotyde. FDA approved Icotyde for patients over the age of 12 with moderate to severe plaque psoriasis. In four studies with over 2,000 patients, around 70% of patients treated with Icotyde had clear or almost clear skin after 16 weeks, and around 50% reported improvements in disease severity of 90% or more. Currently, J&J is testing Icotyde's long-term benefits for psoriasis and whether it can beat Stelara, the company's blockbuster autoimmune treatment. The pill is also being developed for psoriatic arthritis and inflammatory bowel disease. According to analysts, Icotyde could potentially reshape the psoriasis treatment market, which is one of the most competitive fields in the pharmaceutical industry. Patients with psoriasis typically try to control their symptoms with topical treatments before being prescribed injectable therapies, but many opt out of taking injectables due to cost or other reasons. J&J said that its new treatment could help expand the market and bring the company over $5 billion in annual sales at its peak. (Garde, STAT+ [subscription required], 3/18)

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