GSK Seeks MHLW Approval For Hepsera As Single Agent Therapy
This article was originally published in PharmAsia News
GlaxoSmithKline has filed for approval of Hepsera (adefovir pivoxil) as a single agent treatment with Japan's Ministry of Health, Labor and Welfare. Hepsera is currently approved in Japan in combination with Zefix to treat lamivudine-resistant chronic hepatitis B and cirrhosis hepatitis B. However, outside of Japan, Hepsera is also approved as a single agent to treat the diseases. American Association for the Study of Liver Diseases guidelines lists Hepsera as the top option for treating hepatitis B and cirrhosis hepatitis B. (Click here for more - Japanese language
You may also be interested in...
The Centers for Medicare and Medicaid Services has agreed to provide national Medicare coverage for mitral valve transcatheter edge-to-edge repair under a new coverage with evidence development policy. See what Neil Moat, chief medical officer for Abbott’s structural heart business, said about it here.
South Korea’s Ministry of Food and Drug Safety and Taiwan’s Food and Drug Administration will transition from ICCR observers to full members, joining regulatory authorities from the US, Europe, Japan, Canada and Brazil. PCPC’s Francine Lamoriello, EVP of global affairs, discusses.
If Biden administration wants to nominate the acting commissioner, Vacancies Reform Act would dictate the timing. Woodcock can still get the nod and remain head of the agency during the confirmation process, just as Andrew von Eschenbach retained his acting title following his nomination in 2006.