Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February. Until now, Australia did not have a framework for CDx.
BEIJING – U.S. biotech Tracon Pharmaceuticals Inc., of San Diego, has in-licensed from Chinese drugmakers 3D Medicines (Beijing) Co. Ltd. and Jiangsu Alphamab Biopharmaceuticals Co. Ltd. the rights to develop envafolimab, a subcutaneous PD-L1 antibody, to treat soft tissue sarcoma in North America.
Following lengthy consultations with industry, Australia’s Therapeutic Goods Administration (TGA) has released its new regulatory framework for in vitro companion diagnostics (IVD CDx) that becomes effective in February.
A Chinese study has established a previously unknown direct mechanistic link between elevated mechanical tension caused by impaired alveolar regeneration and progressive idiopathic pulmonary fibrosis (IPF), highlighting a pathogenic mechanism that may underlie fibrosis.
KARACHI, Pakistan – Hit by international sanctions, medical device manufacturers in Iran now are looking to get their products out to the world with a little help from neighbor and friend Pakistan. This year, Iran’s med-tech makers have taken their first steps toward finding a new route for their products that goes beyond its neighbors.
Establishment Labs SA, from the Virgin Islands and with main manufacturing and marketing operations in Alajuela, Costa Rica, where it was founded, is entering the Japanese market with what it says is a revolutionary breast implant solution, starting this month.
HONG KONG - With a corporate valuation of $1.04 billion, the South Korean biosimilar company Aprogen Inc. has become the country’s first biotech “unicorn,” according to U.S. market research firm CB Insights. Korea now ranks fifth, tied with Germany, in terms of the number of unicorns, with total of 11 unicorns, a term used to describe private ventures with $1 billion-plus valuations. The U.S has a total of 210 unicorns, followed by China with 102, the U.K. with 22 and India with 18.
BEIJING – Suzhou-based Alphamab Oncology Co. Ltd. (HK:9966), which aims to bring the first PD-L1/CTLA4 bispecific antibody to China, saw its share prices jump almost 30% on its debut on the Hong Kong Stock Exchange (HKEX) on Dec. 12, 2019, ending the year on a positive note for the pre-revenue biotech.
HONG KONG - South Korean biopharmaceutical company Quratis Inc. and Indonesia’s state-run company, Bio Farma PT, have entered a term sheet agreement to develop and commercialize Quratis’ tuberculosis (TB) vaccine, QTP-101, for adults and adolescents.
HONG KONG – Singapore and U.S.-based Hummingbird Bioscience Pte Ltd. has raised $19 million in a series B financing round. Proceeds will be used to support the discovery of new disease targets and to fuel the work of co-discovery projects that are part of an agreement valued with Amgen Inc.