Qrxpharma Ltd., of Sydney, said the FDA established May 25, 2014, as the new Prescription Drug User Fee Act date for action on the company’s refiled new drug application for immediate-release Moxduo, a version of hydrocodone and morphine. The FDA will schedule an advisory committee meeting prior to that date, and assuming approval, the company said it plans to launch the product in the U.S. in the second half of 2014.
HONG KONG – The U.S. FDA plans to add 10 more investigators to its China office to enhance its monitoring of Chinese exports of pharmaceuticals to the U.S.
Daiichi Sankyo Co. Ltd., of Tokyo, reported results of a prespecified subgroup analysis of 771 cancer patients enrolled in the Phase III Hokusai-VTE study, showing that subjects with either a history of cancer or with active cancer treated with once-daily Factor Xa inhibitor edoxaban had a numerically lower incidence of recurrent symptomatic venous thromboembolism compared to warfarin (3.7 percent vs. 7.1 percent).
TAIPEI, TAIWAN – With the official opening in Taiwan of its new preclinical and early clinical quantity biopharmaceutical plant last week, another milestone has been reached in rapid fashion by the upstart JHL Biotech Co. Ltd.
HONG KONG – A novel class of antitubercular drugs, the indol carboxamides, has been shown safe and effective against clinical Mycobacterium tuberculosis isolates in preclinical studies, report Novartis Institute for Tropical Diseases (NITD) in Singapore researchers in the latest issue of Science Translational Medicine.
SHANGHAI – After a flurry of high-level meetings discussing China’s drug pricing, the new leadership said it will continue to apply pressure on drug prices to reduce the cost of healthcare, but will make greater use of market forces.
Since China, Canada and Mexico are the U.S.’ biggest trade partners, it should come as no surprise that they have the most import alerts involving U.S. FDA-regulated products.
SHANGHAI – Few people are as well placed to understand the financing situation of China’s biomedicine sector than Mike Braun, managing partner for Deloitte’s Life Science & Health Financial Advisory Services in China.
BEIJING – At the recent China Trials: Global Clinical Trial Summit here, a confab of chief scientists and contract research organization (CRO) leaders declared that China needs to be elevated and considered much earlier in global trials design.
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