Spyre Therapeutics Inc. is off to a good start in its goal to create the best combination therapy for inflammatory bowel disease, a group of chronic, relapsing autoimmune conditions of the digestive tract that encompasses Crohn’s disease and ulcerative colitis. The Waltham, Mass.-based company estimates the market for IBD is currently at approximately $25 billion but will jump to around $40 billion in 2030.
The development of glucagon-like peptide 1 receptor (GLP-1R) agonists, such as semaglutide and tirzepatide, has been a game changer in the clinical management of overweight and obesity, but there is interpersonal variability in efficacy of these medications for weight loss, as well as in the incidence of undesired side effects. Investigators from the 23andMe Research Institute have shed some light on how variations in the GLP-1R and GIP receptor (GIPR) genes impact their effectiveness and the occurrence of side effects.
The U.S. path forward is narrowing for Vanda Pharmaceuticals Inc.’s tradipitant as a treatment for gastroparesis, a serious disorder for which there’s been no new treatment in several decades.
With the U.S. FDA’s approval of GSK plc’s ileal bile acid transporter (IBAT) inhibitor, Lynavoy (linerixibat), patients with primary biliary cholangitis no longer need off-label treatments for a debilitating internal itch symptom called cholestatic pruritus.
Newco R1 Therapeutics Inc. has launched with an oversubscribed $77.5 million series A, providing the means to take AP-306, a potentially first-in-class hyperphosphatemia therapy through phase IIb development in patients with chronic kidney disease.
China’s National Medical Products Administration has accepted for review Jiuyuan Genetic Biopharmaceutical Co. Ltd.’s drug application for Jikeqin, a biosimilar product to Novo Nordisk A/S’s Wegovy (semaglutide) for obesity.
Coming off a U.S. FDA approval of the first GLP-1 in pill format, Novo Nordisk A/S leaned further into oral drug delivery efforts, partnering with Vivtex Corp. to develop next-generation oral formulations of peptide and protein therapeutics in a potential $2.1 billion deal that marks the highest-profile news for Vivtex since the firm spun out of MIT in 2018.
Shares in Novo Nordisk A/S took another battering after the company announced its next-generation obesity drug Cagrisema failed to show noninferiority to Eli Lilly and Co. Inc.’s Zepbound in an open-label comparator study.
The pressure to replace animal testing with human-relevant assays that are more predictive of human-drug responses has now reached a tipping point, and there is a movement toward greater acceptance of these potentially more translatable tests.
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