Mitsubishi Tanabe Pharma Corp., of Osaka, Japan, said the FDA accepted its new drug application for edaravone (MCI-186), an antioxidant free radical scavenger formulated for intravenous treatment of amyotrophic lateral sclerosis (ALS), and set a PDUFA date of June 16, 2017. If approved, the medicine will be commercialized in the U.S. under the brand name Radicava through the newly formed unit, MT Pharma America Inc. The edaravone NDA was supported by a research program in patients diagnosed with ALS in Japan. Read More

What's been deemed improper payments to doctors and local officials in China and Russia will cost Astrazeneca plc (AZ) more than $5.5 million. Read More

HONG KONG – South Korean biotech firm Genexine Inc. (KOSDAQ: 095700) recently released interim results for its second clinical trial of GX-H9, to treat growth hormone (GH) deficiency. Read More

HONG KONG – A new Japanese study of the effects of environmental and genetic influences on individual differences in proteomics and metabolomics has identified biomarkers for early disease prevention and diagnosis, through the identification and quantification of blood metabolites. Read More

HONG KONG – Swiss multinational Novartis AG's South Korean unit is facing further scrutiny after being charged with illegal rebates in February. South Korean prosecutors indicted a former chief executive of Novartis South Korea, Moon Hak-Sun, along with five other former and current company managers over allegations that they illegally paid doctors KRW2.6 billion (US$2.3 million) in return for prescribing the company's drugs to patients over the span of five years, from 2011 to January this year. The Seoul Western District Prosecutors' Office said it has indicted 28 other people, including 15 doctors and six publishers of medical journals, amounting to a total of 34 people. The first of what may wind up being several trials is scheduled to start Sept. 22. Read More

LONDON – G20 group leaders meeting in Hangzhou, China, reached a united front on the next steps to be taken to combat antimicrobial resistance (AMR), calling for work to address the market failure that leads to underinvestment in research and development into new antibiotics and diagnostics by pharma and med-tech companies. Read More

TOKYO – Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, will attempt to develop a vaccine to tackle the Zika virus with funding from the U.S. government worth up to $311 million. Read More