HONG KONG – China's proposed biosimilar guidelines could open the door for more competition among domestic and foreign producers even though some issues remain unclear, such as the development of more complex next-generation products and how regulators will deal with naming issues.
SHANGHAI – China's hospitals are now required to centralize financial management of clinical trials, set up an enhanced supervision system and strengthen their use of project management tools.
HONG KONG - A team of Japanese scientists has discovered a new single gene mutation that can cause infertility, which not only sheds new light on the causes of that condition, but could also lead to its early detection and treatment based on genetic diagnosis.
NEW DELHI – As India grapples with its annual bouts of post-monsoon dengue outbreaks, Sanofi Pasteur said it hopes to roll out the world's first dengue vaccine in the second half of 2015.
Novabay Pharmaceuticals Inc., of Emeryville, Calif., and China Pioneer Pharma Holdings Ltd., of Shanghai, said Taiwan's Food and Drug Administration cleared Novabay's Neutrophase skin and wound cleanser for sale in Taiwan. Novabay plans to ship Neutrophase to Taiwan in the fourth quarter to support Pioneer's launch in early 2015. Neutrophase previously was approved for sale in mainland China, Singapore, Malaysia and the U.S.
LONDON – One of Europe's leading medical institutes, the Karolinska in Sweden, has secured $128 million for its spin-out companies from Thailand's Charoen Pokphand Group (CP Group), in an unprecedented investment by an Asian company in European university technology.
Wuxi Pharmatech (Cayman) Inc., of Shanghai, said it established a representative office in the Tel Aviv area of Israel, aimed at promoting Wuxi's platform of integrated R&D services to local customers. It also will collaborate with Pontifax, a health care-dedicated venture capital firm based in Israel, to invest in technologies in the region, particularly those that can advance Wuxi's capabilities.
TAIPEI, Taiwan – Twi Biotechnology Inc., the drug development arm of Taipei, Taiwan-headquartered generics firm Twi Pharmaceutical Inc., recently received orphan drug designation from the FDA for the use of its AC-201 drug candidate to topically treat epidermolysis bullosa (EB). With that new indication, AC-201 is currently under development by Twi in three tracks: type 2 diabetes, gout and now for EB, a debilitating skin condition.
HONG KONG – After years of waiting, Chinese biosimilar makers will soon have a comprehensive set of guidelines to follow, likely tipping the scales to make the massive country one of the top markets for biosimilars.
HONG KONG – Researchers from the Li Ka Shing Faculty of Medicine at The University of Hong Kong (HKU) have developed a DNA vaccine against malignant mesothelioma that elicited complete and long-lasting protection against malignancy, while curing pre-existing tumors in mouse models.