Mindray completes Wuhan Dragonbio purchase; G-treeBNT in dry-eye syndrome PhII/b/III trials in S. Korea;

> China-based Mindray Medical International ($MR) has completed the acquisition of the remaining stake in Wuhan Dragonbio Surgical Implant for RMB435 million ($70.2 million). NYSE-listed Mindray is currently the subject of a management-led buyout offer. Release

> Shanghai-based Phagelux, which develops phage-based antibacterial products, has bought U.S.-based OmniLytics for an undisclosed amount. OmniLytics also works on phage products with agricultural pathogens under its AgriPhage brand. Release

> Nasdaq-listed CASI Pharmaceuticals ($CASI) said its Zevalin treatment for non-Hodgkin's lymphoma is available at Hong Kong hospitals through local partner Global Medical Solutions Hong Kong. In June, China-focused CASI filed a China FDA application to conduct a Phase II clinical trial in fibrolamellar carcinoma patients for proprietary drug candidate ENMD-2076. In September 2014, Spectrum Pharmaceuticals ($SPPI) licensed two of its cancer drugs, Zevalin and Marqibo, and a Phase III candidate to CASI to develop and sell in China. Release

> Singapore's A*STAR has joined hands with Agilent to develop a more accurate and faster way of testing the sugar content of therapeutic proteins and monoclonal antibodies used by commercial producers to meet harmonization calls backed by the U.S. FDA and European Medicines Agency to characterize the compounds in detail. Release

> At least 20,000 patients will be screened for early signs of gastric cancer in China using the GastroPanel test developed by Finland's Biohit Oyj, a release said, adding that the process should cover around 6 months. In 2013, Biohit signed a joint venture with China's Anhui Wisdom-Win Investment to form Biohit Biotech (Hefei), giving the local company a 60% holding. Release

> The China FDA said 6 unnamed drug wholesale companies in Jilin and Shaanxi provinces were found to have "seriously violated regulations" after surprise inspections, including storing drugs from unknown origin, fabricating locations of offices and warehouses and others. Two of the companies lost licenses for illegally selling medicine with codeine in 2014, while four were ordered to suspend business. All had certificates of Good Supply Practice for Pharmaceutical Products revoked. Report

> South Korea's G-treeBNT has received a Ministry of Food and Drug Safety nod for Phase IIb/III clinical trials on dry-eye syndrome candidate GBT-201/RGN-259 licensed from U.S.-based RegeneRx Biopharmaceuticals ($RGRX), making it the first company in the country to reach that trial status for DES treatment. Release

> China's Zhejiang Garden Biochemical High-Tech plans to raise up to RMB540 million ($86.97 million) in a private placement of shares to fund projects and replenish working capital. Release (Chinese language); Release (Chinese language)

> China's Zhongsheng Pharmacy said it has signed a pact to work with WuXi AppTec ($WX) on unspecified research and development projects. Release (Chinese language)

> Swiss-based Roche ($RHHBY) said it would expand its HIV Global Access Program to include early infant HIV diagnostic testing for low- and middle-income countries in partnership with the Joint United Nations Programme on HIV/AIDS, the Clinton Health Access Initiative, UNITAID, the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to fight AIDS, TB and Malaria. Roche said it would provide its dual-target COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test version 2.0 at an affordable price to qualifying organizations in 82 countries with the highest disease burden. Release

> The China FDA has released the third appendix on supervision and quality management. This one covers good manufacturing practices for sterile medical devices. The first two issues covered implantable medical devices and in vitro diagnostic reagents, with all taking effect on Oct. 1, 2015. Release (Chinese language)

> The China FDA has released an annual report for 2014 on Adverse Drug Reaction Monitoring that it said showed wider reporting efforts by pharmaceutical regulatory authorities, health administrative departments and medical institutions. Release (Chinese language)

> The China FDA has released an annual report for 2014 on Adverse Medical Device Reaction Monitoring that showed an improved trend of reporting across all classes of equipment. A separate report from state-run Xinhua news agency said 41,018 medical device adverse events were reported in 2014, up 18.6% from the previous year, citing CFDA figures. Release (Chinese language)

> India's Commerce Ministry is gearing up for an industry-wide track-and-trace technology system for all Indian drug exporting companies, the Hindustan Times reported. The plan is for companies to adhere to prescribed manufacturing data on various levels of packaging by October. "We are planning to build a database on domestic manufacturers that will be open for regulators and retailers across the globe," a senior official from the department of pharmaceuticals told the newspaper. Report