SHANGHAI – At the 5th Annual Biosimilars Asia conference held here, a varied mix of Asian biosimilar developers and the consultants that advise them were on hand to discuss the commercial opportunity for biosimilars, if one can only figure out the numerous and costly challenges first. Read More

HONG KONG – The CFDA's new rules covering food, drugs and medical devices give the accused the chance to petition for a hearing and outline the investigative path authorities must follow, including the use of evidence from outside of the country, before levying penalties that range from fines to shutting operations. Read More

HONG KONG – Imaging agents maker Imaginab Inc. has launched a wholly owned subsidiary – Imaginab Japan KK – in Tokyo, as part of a plan to grab a bigger share of the world's second largest pharmaceutical market. Read More

HONG KONG – Growing domestic and international sales of vaccines buoyed strong growth for one of China's top biotechs, as reflected in its first quarter results for 2014. Beijing-based Sinovac Biotech Ltd. (NASDAQ:SVA) reported $13.5 million in sales, a jump of 34.8 percent from $10.1 million during the same period in 2013. Sinovac's shares lost 21 cents Thursday, to close at $6.06. Read More

LONDON – An expedited approval system for regenerative medicines coming into effect in Japan in November will provide a possible route for cell therapy companies from around the world to get conditional approval and reimbursement on the basis of phase I/II data confirming safety and indicating a product is likely to be effective. Read More

Coming as little surprise after an FDA advisory panel backed Entyvio (vedolizumab) for treatment of severe ulcerative colitis and moderate to severe Crohn's disease, Takeda Pharmaceutical Co. Ltd.'s drug gained approval on its May 20 PDUFA date, becoming the first integrin inhibitor to hit the market since Biogen Idec Inc.'s Tysabri (natalizumab). Read More

Daiichi Sankyo Co. Ltd., of Tokyo, began a three-year research project with Sanford-Burnham Medical Research Institute, of La Jolla, Calif., to investigate cardiovascular-metabolic diseases. Terms of the agreement, which will deploy Sanford's screening capabilities, were not disclosed. Read More