SHANGHAI – Hutchison China Meditech Ltd., or Chi-Med, has begun human trials for HMPL-689, a PI3K delta blocker for the potential treatment of blood cancers that it hopes can be best in class by overcoming a rival’s safety issues. The trial kicked off in Australia dosing 50 healthy volunteers. Read More
NEW DELHI – The U.S. FDA has rapped yet another Indian pharma company with a warning letter that drew attention to “significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals.” Read More
TOKYO – Harmonizing the regulatory environment across Asia and making it easier to get drugs to the market should be the priority for government agencies across the continent, said participants at the Drug Information Association’s Asia New Drug Conference. Read More
TOKYO – China’s government and drug regulator is moving toward internationalization. And while the push may seem slow, the sheer number of reforms under way may be difficult to stay on top of for multinationals. Read More
HONG KONG – Researchers at the National Institute for Physiological Sciences (NIPS) in Okazaki, Japan, have identified events in the primary sensory (S1) cortex of the brain that contribute to sustained mechanical allodynia and may represent a new therapeutic target for pain relief, they reported in the April 11, 2016, edition of the Journal of Clinical Investigation. Read More
Having worked in academia, big pharma and venture capital, Naia Ltd. co-founder H. Daniel Perez got to witness drug development from three different perspectives, and he came away with one conclusion: “It was very clear things were not being done efficiently,” he said. Read More
Orexigen Pharmaceuticals Inc., of San Diego, issued a statement relating to the acquisition of full U.S. rights to Contrave (naltrexone HCl / bupropion HCl extended release) from Osaka, Japan-based Takeda Pharmaceutical Co. Ltd. Transfer of the recently initiated multiyear Convene trial involves substantial complexity due to the scope, size and nature of the study, the company said. Read More
