WAVES, an algorithm designed to extract menstrual-cycle metrics from physiological signals such as basal body temperature, which oscillates with sex hormones, shows how different parameters change with age and helps determine whether each person maintains a stable individual pattern or personal footprint. A study based on data from 5,674 cycles from 753 women demonstrates through this tool that age is associated with higher temperatures, shorter cycles, and greater irregularity. In addition, several metrics show within-person stability, suggesting they could serve as personalized health markers.
Seven years, almost to the day, after releasing a draft guidance on post-approval pregnancy safety studies, the U.S. FDA is now finalizing it – albeit with a few changes.
Changchun Genescience Pharmaceuticals Co. Ltd. has prepared and tested new steroid compounds acting as estradiol 17-β-dehydrogenase 1 (HSD17B1; 17β-HSD1) inhibitors that are potentially useful for the treatment of endometriosis.
Insilico Medicine Cayman Topco has established a strategic research collaboration with Aska Pharmaceutical Co. Ltd. to identify novel therapeutic targets for challenging gynecological conditions, including endometriosis, uterine fibroids and adenomyosis.
Endomet Biosciences Inc. (dba Endocyclic Therapeutics) has obtained IND clearance from the FDA for its lead program, ENDO-205, a first-in-class, nonhormonal targeted peptide therapeutic for endometriosis.
Teijin Pharma Ltd. has entered into a joint research agreement with Aska Pharmaceutical Co. Ltd. to jointly develop novel small-molecule drug candidates for gynecological diseases.
Laborie Medical Technologies Corp. secured a new gem for its maternal health with the acquisition of the Jada system from Organon & Co. The terms of the deal, first announced in November, included payment of $440 million at closing, with an additional $25 million tied to 2026 revenue targets.
Prenaital ApS has filed a patent for technology that may identify risks of spontaneous pre-term birth. Spontaneous preterm birth (sPTB) is usually defined as birth occurring before 37 weeks of gestation. The invention relates to a method for predicting potential preterm birth from medical scan data, which may be used in practice by medical professionals for risk analysis and prognosis of potential pathologies.
Genedx Holding Corp. launched Genomedx Prenatal, its whole genome sequencing test, to provide more definitive diagnoses of the causes of fetal abnormalities identified by ultrasound. By combining the company’s decade of experience in prenatal exome testing and its massive Genedx Infinity rare disease dataset, the test can determine not just whether a pregnancy has a risk of a genetic disorder but whether the fetus actually has a genetic disorder.