PERTH, Australia – Cyclopharm Ltd. said it received a complete response letter (CRL) from the FDA for its Technegas NDA for pulmonary embolisms. The CRL relates to better defining and validating production and delivery of the Technegas particle and other aspects of crucible manufacturing and dosimetry that need to be addressed before the NDA can be approved.
PERTH, Australia – Australia’s Medical Technologies and Pharmaceuticals Industry Growth Center (MTPConnect) is boosting funding for the translation and commercialization of research in diabetes, cardiovascular disease and regenerative medicine.
HONG KONG – With the sale of a group of noncore assets to a little-known Chinese company, Takeda Pharmaceutical Co. Ltd. took another step in a multibillion-dollar string of divestitures that is part of a plan to cut debt and focus on five key business areas. Takeda announced on Dec. 21 the sale of a portfolio of noncore prescription drugs marketed in China to Hasten Biopharmaceutic Co. Ltd. (China).
PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease.
HONG KONG – Stempeutics Research Pvt Ltd. received the green light from the Drug Controller General of India (DCGI) to launch its Stempeucel therapy to treat critical limb ischemia (CLI) due to Buerger’s disease and atherosclerotic peripheral arterial disease.
HONG KONG – Tokyo-based Daiichi Sankyo Co. Ltd. has hit its goals in a phase III study testing the use of prasugrel hydrochloride in thrombotic stroke patients.
HONG KONG – Korea’s Celltrion Inc. aims to wrap up its first major M&A deal with Japan’s Takeda Pharmaceutical Inc. by the end of 2020, pending approvals.
PERTH, Australia – While the coronavirus captures the world’s attention, another global pandemic is quietly killing 100 million people under the age of 60.
BEIJING – Chinese biosimilar maker Bio-Thera Solutions Ltd., of Guangzhou, on Feb. 21 launched a pre-revenue listing on Shanghai’s STAR market to reap $241 million at a valuation of almost $2 billion.
The pending Abbvie Inc. merger with Allergan plc, expected to close in the first quarter, brought good tidings to another “A” company on Monday, allowing Astrazeneca plc to regain global rights to its late-stage Crohn’s disease and ulcerative colitis (UC) drug, brazikumab.
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