Tokyo-based Astellas Pharma Inc. is buying Belgium's Ogeda SA for €500 million (US$532.7 million) up front and up to €300 million in milestone payments tied to the clinical and regulatory advancement of fezolinetant, a midstage nonhormonal treatment for menopause-related vasomotor symptoms (MR-VMS). If successful, it could potentially broaden the options for women seeking an alternative to estrogens and progestogens, which though commonly used to treat MR-VMS, have been associated with heightened risks of breast cancer, stroke and thromboembolism. Read More
Astellas Pharma Inc., of Tokyo, appointed John DeMay president, Astellas US Technologies Inc. (AUST). DeMay will be responsible for promoting collaboration and cooperation across pharmaceutical technology division functions in the Americas. He will also serve as the site manager for AUST based in Northbrook Ill., and will represent AUST in various Americas management activities. DeMay will also continue to serve as head of project and product management group within Astellas' pharmaceutical technology. Read More
Genexine Inc., of Seoul, South Korea, and Handok Inc., also of Seoul, presented interim results from the phase II trials of long-acting human growth hormone candidate GX-H9 in pediatric growth hormone deficiency and adult growth hormone deficiency (GHD) at the ENDO 2017 meeting in Orlando, Fla. In the pediatric study, GX-H9 demonstrated annualized height velocities comparable to that of active comparator, daily recombinant human growth hormone (hGH) at three months, with data showing mean annualized height velocities of 10.7 cm and 15.3 cm for the two weekly doses of 0.8 mg/kg and 1.2 mg/kg, respectively. Read More
SHANGHAI – Shanghai-based biotech Zai Labs Ltd. is adding biologics manufacturing capabilities to its business model of developing new drugs for China via in-licensing assets and in-house biologics discovery. The site will be located in Suzhou Biobay and will make clinical trial quantity Biotherapeutics, with the possibility of scaling to commercial quantities at a later stage. Read More
HONG KONG – The global market for traditional Chinese medicine (TCM) is growing rapidly as researchers make strides in applying modern drug development techniques to TCM development. However, regulatory hurdles for TCM clinical trials are slowing down progress. Read More
HONG KONG – A deal between South Korean biopharmaceutical firm Alteogen Inc. and Chinese company Qilu Pharmaceutical Co. Ltd. to complete development of a biosimilar drug suggests the technology gap between the two countries is closing, and underlines the fact that recent political tensions between the two countries have had little impact on the biotech industry. Read More
An Australian Senate committee recommended last week that Parliament pass the Therapeutic Goods Amendment Bill (2016 Measures No. 1) that would overhaul drug and device regulations to speed access to novel therapies and reduce regulatory red tape. Read More
SHANGHAI – Suzhou-based Innovent Biologics Inc. and Hanmi Pharmaceuticals Co. Ltd., of Seoul, South Korea, will pair up to co-develop and co-commercialize a bispecific immuno-oncology antibody for breast cancer with the possibility of other indications to follow. The molecule is expected to enter clinical trials in 2019. Read More
