Fractyl Laboratories Inc. is pioneering a procedure known as duodenal mucosal resurfacing (DMR) to reverse chronic metabolic disorders. This month it has reported positive results from a couple of clinical trials that are shaping its planning for a pivotal trial that is slated to start next year in type 2 diabetes patients.
HONG KONG – Singaporean drugmaker Aslan Pharmaceuticals Ltd. announced top-line data from its pivotal phase III TreeTopp (treatment opportunity with varlitinib (ASLAN-001) in biliary tract cancer) study in second-line biliary tract cancer patients, which failed to meet co-primary endpoints of progression-free survival (PFS) and overall response rate (ORR).
Pairing the in-licensed muscarinic acetylcholine receptor agonist xanomeline with the well-known muscarinic antagonist trospium chloride in the single drug called Karxt gave Karuna Therapeutics Inc. the required phase II efficacy against acute psychosis in schizophrenia, while keeping a quite satisfactory safety and side-effect profile.
Edwards Lifesciences and Medtronic have struggled for supremacy for transcatheter aortic valve devices for several years, but two recent studies suggest the Edwards line of devices provide better outcomes. However, another study gave new life to the notion that TAVR devices are underutilized, signaling that there is plenty of market for both companies.
Restorbio Inc.'s PROTECTOR 1 phase III study failed to meet its primary endpoint and the company shares tracked deeply downward Friday. The trial was designed to evaluate RTB-101 in preventing clinically symptomatic respiratory illness (CSRI) in adults ages 65 and older.
A second phase II failure to differentiate from placebo in a test of benefits for people with depression has put AV-101, an NMDA receptor antagonist developed by Vistagen Therapeutics Inc., in uncertain territory.
HONG KONG – Singaporean drugmaker Aslan Pharmaceuticals Ltd. announced top-line data from its pivotal phase III TreeTopp (treatment opportunity with varlitinib (ASLAN-001) in biliary tract cancer) study in second-line biliary tract cancer patients, which failed to meet co-primary endpoints of progression-free survival (PFS) and overall response rate (ORR).
Therapix Biosciences Ltd., of Tel Aviv, Israel, said top-line results of a small single-arm, phase IIa study of its combination of dronabinol (delta-9-tetrahydracannabinol) and Cannamide (palmitoylethanolamide), THX-110, showed a positive effect on symptoms of obstructive sleep apnea (OSA), a serious sleep disorder.
SHANGHAI – Innovation-driven biotech companies are sprouting up in China and they now aim to gain a bigger global presence through conducting clinical trials not just in their home country but also abroad.
A little more than two months after completing enrollment, an interim analysis shows Kadmon Holdings Inc.'s pivotal trial of ROCKstar (KD-025-213) testing KD-025 in patients with chronic graft-vs.-host disease (cGVHD) met its primary endpoint of overall response rate.
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