Hun-taek Kim founded Tiumbio Co. Ltd. in 2016 after spending more than two decades at a major chemical and life science firm, SK Chemicals Co. Ltd. “The prospects for our three major assets are very bright, and the probability of failure is low,” CEO Kim told BioWorld.
Hun-taek Kim founded Tiumbio Co. Ltd. in 2016 after spending more than two decades at a major chemical and life science firm, SK Chemicals Co. Ltd. “The prospects for our three major assets are very bright, and the probability of failure is low,” CEO Kim told BioWorld. “We’re looking for a breakthrough in rare diseases – to develop new treatments for [niche] markets with large unmet demand.”
The U.S. FDA has issued a final guidance for non-clinical performance testing for tissue containment bags used during power morcellation procedures, and the FDA had recommended in 2020 containment bags always be used during morcellation procedures. Despite the FDA’s advisory, a survey of surgeons published last year suggested that most of these procedures are not done with these containment systems, possibly because the rate of procedure-related complications is considerably higher when containment is used.
Medshine Discovery Inc. has patented gonadotropin-releasing hormone receptor (GnRHR) antagonists reported to be useful for the treatment of endometriosis and uterine fibroids.
The FDA has continued a series of device risk classifications with the formal announcement that general containment systems used with power morcellators will henceforth be deemed class II, moderate-risk devices.
With the PDUFA date for relugolix against prostate cancer growing nearer and data in castration resistance-free patients closer still, Myovant Sciences GmbH aims to wring more from the oral, once-daily gonadotropin-releasing hormone receptor antagonist, studying it in uterine fibroids and endometriosis.
Geneva-based Obseva SA’s top-line data from the pivotal phase III studies called Primrose 1 and 2 with GnRH antagonist Yselty (linzagolix) pleased the company, but Wall Street not so much.
Geneva-based Obseva SA’s phase III Primrose 2 trial with gonadotropin-releasing hormone (GnRH) antagonist linzagolix in heavy menstrual bleeding (HMB) due to uterine fibroids (UFs) hit the primary endpoint in 94% of patients, and the company in the second quarter of 2020 will report six-month data from the Primrose 1 study, which is also a phase III experiment, in the same indication.
LONDON – Kandy Therapeutics Ltd. has announced positive results for its nonhormonal treatment for menopause symptoms, showing a reduction in the number of hot flashes and night sweats, and a positive effect on secondary endpoints relating to mood and quality of life.