When the time was right to make a powerful Western biotech welcome in China, Beigene Ltd. was ready when Amgen Inc. came calling. Its massive $2.7 billion cash equity investment in Beigene buys Amgen an oncology footprint in China. Read More
LONDON – The Swiss headquarter operations of Arvelle Therapeutics GmbH are taking shape as the company awaits the outcome later this month of the FDA's deliberations on its in-licensed asset, cenobamate, and prepares to apply for EMA approval for the novel epilepsy treatment in the first half of 2020.
San Diego-based Otonomy Inc.'s launch of the phase I/II trial for OTO-413, a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), in patients with hearing loss brought renewed investor attention to the company, consigned to the back burner after a late-stage failure. Read More
MELBOURNE, Australia – Although Australia's Therapeutic Goods Administration (TGA) approved its first CAR T therapy in 2018, the country is lacking a system to reimburse those advanced therapies, and industry is calling on government to revalue gene therapies so that patients can access them. Read More
A subtype of schizophrenia is related to abnormally high brain levels of hydrogen sulfide (H2S), which has important implications for the development of new treatments, according to a study by researchers at the RIKEN Center for Brain Science (CBS) in Japan. Read More
HONG KONG – South Korean AI-based biotech Azoth Bio Inc., of Seongnam, Gyeonggi-do, and biopharmaceutical venture Wellmarker Bio Co. Ltd., based in Seoul, have signed a memorandum of understanding for cancer drug R&D and commercialization. Under the agreement, the two entities will use Azoth's AI-powered platform to develop Wellmarker's cancer treatment candidates. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
