The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers. Vafseo Chronology: Comple...
Japan’s Virtual Currency Exchange Association (JVCEA) will reportedly be releasing new voluntary rules next week,Cointelegraph Japanreports today, June 18. The official announcement of the regulatory guidelines, set for June 27th, will reportedly include a ban on insider trading, penalizing cry...
A deeper mechanistic understanding of the gene regulatory networks of regeneration pathways might ultimately enable their targeted reactivation as a means to treat human injuries and degenerative diseases. In this Review, we consider the regeneration of body parts across a range of tissues and species ...
This contributes to achieving the objectives of Safety Conventions.K.AkutagawaSafety Information Research Division,rnJapan Nuclear Energy Safety Organization (JNES),rnTokyo, Japan;Challenges Faced by Technical and Scientific Support Organizations in Enhancing Nuclear Safety...
Some countries (e.g. Japan, Russia) may require that thorough reviews of any available animal data even if they are not traditional nonclinical toxicity data, be included in clinical trial applications (CTAs). If this information is deemed insufficient, requests may be made to conduct routine ...
Regulatory T cells (TReg cells) are a special subset of T cells that prevent other immune cells from attacking the body’s own tissues and other harmless environmental materials, such as food and commensal organisms. Defects in regulatory T cells cause severe inflammatory disease. Latest Research...
ICH, first created in 1990 by regulatory agencies and both brand and generic drug manufacturing associations from the United States, Europe, and Japan, was established to facilitate international collaboration, and has been successful in standardizing and elevating drug development practices throughout the...
The SCRUM-Japan Registry has been instrumental in achieving the world’s first regulatory approval for human epidermal growth factor receptor 2 (HER2)-positive colorectal cancer, demonstrating the value of regulatory-grade registries in managing rare molecular subtypes. However, the broader adoption of ...
With this approval, HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] becomes the first and only facilitated subcutaneous immunoglobulin available in Japan to treat these disorders. First Generic of a GLP-1 Injection Gets FDA Nod to Treat Type 2 Diabetes ...
Japan power cord notice Macrovision Corporation notice This product incorporates copyright protection technology that is protected by method claims of certain U.S. patents and other intellectual property rights owned by Macrovision Corporation and other rights owners. Use of this copyright protection ...