Taiwan's TWi wins U.S. court round on Par's Megace; China's Walvax buys 21% stake in Guangdong Wellen;

> Taiwan's TWi Pharmaceuticals has launched a generic version of Par Pharmaceutical's Megace following a U.S. federal court ruling that found the patent invalid, the company said in a press release. Release

> A U.S. federal court has ruled that a proposed generic version of Bayer AG's Finacea from India's Glenmark Pharmaceuticals infringes on the German firm's patent. Report

> Japan's Astellas said topline results from a Phase III study of Cresembafor in adults with candidemia and other invasive Candida infections failed to meet its primary endpoint of noninferiority in overall treatment response in isavuconazole-treated patients compared to caspofungin. Release

> Boehringer Ingleheim has launched its first Traditional Chinese Medicine product for over-the-counter sales in China. The product treats chronic constipation and will be made by China's Fu Jen Catholic Pharmaceutical Group, with marketing, sales and distribution by BI, the company said in a press release. Release (Chinese language)

> Australia's Neuren Pharma said the European Medicines Agency has recommended orphan designation for the drug trofinetide in both Rett syndrome and Fragile X syndrome and could grant formal confirmation next month. It also said it had a "productive" meeting with the U.S. FDA on remaining development for Rett syndrome and plans a Phase III design for the candidate. Release (PDF)

> China's National Center for Protein Science in Shanghai has passed a national evaluation with a $122 million facility designed to enhance major disease studies and clinical diagnosis and treatment, under trial operations since May 2014, according to state-run Xinhua news agency. Report

> Japan's Kyowa Hakko Kirin and Bristol-Myers Squibb ($BMY) will collaborate on a U.S. Phase I/II study of mogamulizumab (Poteligeo) and Opdivo in advanced solid tumors, eyeing whether a combination of the two therapies are a potential treatment option for patients with advanced or metastatic solid tumors. Release

> Japan's Daiichi Sankyo's U.S.-based Plexxikon unit reported that investigational drug, PLX3397, an oral targeted CSF-1R inhibitor did not yet reach median progression-free survival for patients with tenosynovial giant cell tumor (TGCT), in a Phase I study, but showed "encouraging" results in inducing tumor regressions in most patients, according to an article published in the New England Journal of Medicine. "The patient responses highlighted in the NEJM publication are very encouraging and underscore our rationale for initiating a global, (Phase III) study of PLX3397 in TGCT," said Paul S. Lin, CEO of Plexxikon, in the release. "Our TGCT trial offers important preliminary proof-of-concept on the efficacy of selective CSF-1R inhibition.The targeted molecular design of PLX3397 is another hallmark of our efforts to bring new targeted therapies to patients who need them." Release

> China-based cancer diagnostics firm Shuwen Biotech plans to work with Jiangsu Hengrui Medicine to develop a companion diagnostic for an unspecified Hengrui cancer treatment. Release

> China's Walvax Biotechnology has bought a 21% stake in Guangdong Wellen Biological Pharmaceutical with plans for the acquired company to continue to development, production and sales of biological products. Report

> India's Dr. Reddy's Laboratories ($RDY) has signed an agreement to work with Indiana's Purdue University on pharmaceutical process and product development research that covers delivery, manufacturing and operations. Report

> China's Suzhou Connect Biopharma said a Phase I study of autoimmune candidate CBP-307 was successfully completed in work done at its Australian unit in Melbourne. The company said CBP-307 exhibited highly potent immune modulation activity at each of the studied doses. Release

> Taiwan's new labeling system to make prescription drug and container information accessible to the visually impaired will start trials next month using voice and large fonts and launch by the end of the year if successful. Report

> Japan's Mitsubishi Tanabe Pharma plans to reorganize its three drug development-related divisions in an effort to speed up new launches with a target for Oct. 1 to complete the reshuffle. Report

> Japan's Eisai has submitted a new drug application in Japan for its in-house-discovered antiepileptic drug Fycompa as an adjunctive therapy for partial-onset and primary generalized tonic-clonic seizures. Release

> Japan's Kyowa Hakko Kirin has started a Phase III trial of candidate KHK4563 (benralizumab) to treat chronic obstructive pulmonary disease in Japan. The candidate is already in multiregional clinical trials started by AstraZeneca ($AZN). Release

> China's Yabao Pharma has started preclinical work on a candidate based on annexin A5 for the treatment of sepsis that was in-licensed for Greater China rights in 2014 from Canada's Lawson Health Research Institute. Release

> China's Bloomage BioTechnology and South Korea's Medytox agreed to a joint venture for China marketing of a Botox version made by Medytox. The product, to be called Medybloom, fits in with Bloomage's aesthetic care business. Release (PDF)

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