Deciphera Pharmaceuticals Inc. CEO Steven Hoerter told BioWorld Asia the FDA approval of Turalio (pexidartinib) from Daiichi Sankyo Co. Ltd. last week "leaves a lot of headroom for efficacy," given the response rate of about 40%. "One of the most significant concerns that the FDA had was hepatotoxicity, which is an off-target effect," he added, so the approval came with "some fairly onerous monitoring requirements." Read More
Tokyo-based Daiichi Sankyo Co. Ltd.'s Turalio (pexidartinib) won FDA clearance for adults with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery. Read More
Telix Pharmaceuticals Ltd., of Melbourne, Australia, said it will work with the German Cancer Research Center (Deutsches Krebsforschungszentrum) on image-guided prostate cancer surgery using a radiotracer based on 68Ga-PSMA-11, currently under development by Telix as TLX591-CDx and marketed as Illumet in the U.S. Read More
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HONG KONG – Vietnam is emerging as a favorable market for multinational drugmakers, thanks to new trade agreements that provide more protection to patent holders and policies that welcome drug imports. Some companies have already made their moves in the populous Southeast Asian country. Read More
HONG KONG – The new Shanghai Stock Exchange's Science and Technology Innovation board, officially launched in late July, marks China's boldest move yet to attract biopharma and technology companies to its often-turbulent financial markets. Read More
Aveo Oncology Inc. and Kyowa Kirin Co. Ltd. amended their 2006 license agreement so that Kyowa Kirin can buy back the non-oncology rights of tivozanib in Aveo territories, including the U.S. and the EU, while Aveo retains U.S. rights in cancer. Read More
Rakuten Medical Inc., the developer of a precision photoimmunotherapy platform targeting head and neck cancer, has raised about $100 million in a series C-1 preferred stock financing from Rakuten Inc., a global internet services company headquartered in Japan that now owns 22.5% of the company. Read More
HONG KONG – The Singapore government will be launching a pilot program that could help biotech and med-tech companies thrive in both the country and Asia. The two-year pilot, Tech@SG, set up by the Economic Development Board (EDB) and Enterprise Singapore, aims to provide companies access to business networks and talent. Read More
HONG KONG – Chengdu-based Hinova Pharmaceuticals Inc., of China's Sichuan province, closed a series B financing that added $40 million to the company's pocket. The proceeds will go to the global phase III study for lead asset HC-1119 for prostate cancer. Read More
LONDON – It's the technology that keeps on giving, and the Heptares unit of Sosei Group Corp. has attracted a further partner to its G protein-coupled receptor (GPCR) platform, signing up Takeda Pharmaceutical Ltd., in a deal worth up to $1.2 billion. Read More