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...
Procter & Gamble, through its UK wellness subsidiary Nature's Best, is on-trend with new vegan vitamin D3 and iron supplements. Nature's Best has also launched three other vitamin D3 products in the country, as well as an ashwagandha supplement.
The MHRA has updated its guidance on regulatory flexibilities for medical devices and medicinal products resulting from COVID-19 to highlight how its approach differs from the EU.
The Swiss company is planning a US trial of CBSO, the first transcatheter septal occluder with a bioresorbable, metal-free frame.