The U.S. Food and Drug Administration decided to put together an advisory committee meeting of outside experts to review a New Drug Application (NDA) for FibroGen and partner AstraZeneca’s investigational anemia therapy roxadustat.
Shares of Fujifilm Holdings Corp. fell after Kyodo news reported that so far there has been no clear evidence of efficacy for the company’s drug Avigan in treating the novel coronavirus in some clinical trials.
Japan approved Gilead Sciences Inc.’s remdesivir as a treatment for COVID-19, marking the country’s first officially authorized drug to tackle the coronavirus disease.
The U.S. FDA gave Alexion Pharmaceuticals a thumbs-up for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder in adults that express a specific biomarker.
Swiss drugmaker Roche’s push into personalized cancer medicines hit a milestone with Japanese approval of a new drug, Rozlytrek, that targets patients who must be identified via genetic profiling.
The U.S. Food and Drug Administration accepted for review Orion and Bayer’s New Drug Application for darolutamide for the treatment of non-metastatic castration-resistant prostate cancer.
South Korea’s Biostar Stem Cell Research Institute – jointly operated by Nature Cell and Rbio – announced that Trinity Clinic Fukuoka, a partner hospital in Japan, received approval for the application of regenerative medicine in Alzheimer’s disease and officially began stem cell treatment as of April 12.
AstraZeneca and Merck announced that the Japanese Ministry of Health, Labour and Welfare approved Lynparza (olaparib) tablets (300mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer, regardless of their BRCA mutation status, who responded to their last platinum-based chemotherapy.
Alexion Pharmaceuticals Inc. announced that the MHLW in Japan approved Soliris (eculizumab) as a treatment for patients with generalized myasthenia gravis.
The new generation of hep C drugs has completely changed the conversation about launches.