HONG KONG – Astrazeneca plc has won two new approvals from Japan's PMDA for its Lynparza (olaparib) in breast cancer as well as chemotherapy maintenance drug Imfinzi (durvalumab), a further sign that the country is getting faster in approving these drugs, reflecting an urgency in accessing newer cancer treatments. Read More
HONG KONG – Ever since the Hong Kong Stock Exchange (HKEX) lowered the listing bar for biotech startups that are yet to generate revenue, the bourse keeps receiving applications from biotech firms both inside and outside China. Read More
SHANGHAI – Zai Labs Ltd. has kicked off a phase III China study of ZL-2306 (niraparib), a poly ADP-ribose polymerase (PARP) inhibitor that prolongs the life of women with ovarian cancer. Read More
HONG KONG – Hangzhou, China-based Adlai Nortye Biopharma Co. Ltd. said Tuesday it partnered with Novartis AG to obtain the worldwide rights to BKM-120 (buparlisib), a selective PI3K inhibitor, to treat head and neck cancer, adding one more lead product to the Chinese company's oncology pipeline. Read More
HONG KONG – South Korean company Alteogen Inc. is working with its U.S. partner, Lynkogen Inc., of New Jersey, to develop novel GLP-1 mimetic and alpha-1 antitrypsin (A1AT) fusion proteins for the treatment of nonalcoholic steatohepatitis (NASH) and metabolic diseases. Clinical trials could begin in two years' time. Read More
HONG KONG – Compugen Inc. has two investigational new drug applications (INDs) recently approved by the FDA, as the Israeli company is set to transform from a predictive drug discovery and development company into a clinical-stage venture. Read More
PERTH, Australia – Sydney-based gene therapy company Benitec Biopharma Ltd. saw its stock more than double following a global out-licensing deal with Axovant Sciences Ltd. valued at $187.5 million for its DNA-directed RNA interference (ddRNAi) therapy BB-301. Read More
PERTH, Australia – Melbourne-based regenerative medicine company Cynata Therapeutics Ltd. is gearing up to take its Cymerus mesenchymal stem cell (MSC) product candidate CYP-001 into phase II trials after reporting solid results in two cohorts of patients in its phase I trial in steroid-resistant graft-vs.-host disease (GvHD). Read More
NEW DELHI, India – India's drugs standards regulatory authority has recommended the introduction of a track and trace system for the top 300 pharmaceutical brands sold by 66 companies, in a bid to curb the sale of counterfeit or substandard drugs in the country. Read More
Sinovac Biotech Ltd., of Beijing, reported it completed an $86.73 million private placement of its common shares with Vivo Capital and Advantech Capital, which both received a total of 5.9 million common shares for $7.35 per share. The proceeds will be used to increase the company's capabilities in research relating to quality control and to build additional production facilities to support the development and commercialization of sIPV-based combination vaccine and other new vaccine projects. Read More
Histoindex Pte. Ltd., of Singapore, appointed Poon Thong Yuen CEO. He has more than a decade of corporate experience with healthcare services, therapeutic drugs and medical devices. Read More
