Preclinical
Amgen reunites with Kyowa Kirin on the development and potential commercialization of KHK4083, an atopic dermatitis drug, which impacts nearly 30 million people worldwide.
The FDA gave the green light to Amgen’s Lumakras under accelerated approval as a treatment for patients with KRAS mutation whose disease has worsened over time.
The question before the committee was whether the benefits of teplizumab outweigh the risks as it voted 10-7 in favor of the drug to delay clinical type 1 diabetes mellitus.
Fennec is looking for a second chance to approve PEDMARK, its pediatric chemotherapy-induced hearing loss prevention drug, as it resubmits its NDA for the agent to the U.S. FDA.
A two-stage Phase III clinical trial by Sanofi and GSK, is studying a COVID-19 vaccine candidate targeting the original SARS-CoV-2 strain as well as the South African B.1.351 variant.
The EUA was granted base on interim data from the Phase III COMET-ICE trial in high-risk adult outpatients.
The U.S. FDA has granted approval to MYFEMBREE, Myovant Sciences, and Pfizer’s once-daily treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
This is the second IND to come out of the two companies’ collaboration. They will initiate a Phase I trial of the drug in cardiometabolic diseases.
When the pandemic hit, many companies diverted resources aimed at HIV to COVID-19, which ended up pausing some research efforts.
The company says it plans to file an IND for the candidate, dubbed CFT8919, by the middle of next year.
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