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 – Gene therapy startup Hui-Gene Therapeutics Ltd. Co., of Shanghai, said it secured more than ¥100 million (US$14 million) in a series A financing round to develop a safer gene therapy to treat genetic diseases caused by single-base mutations.
Four new U.S. drug approvals, one accelerated for need, have handed a string of year-end victories to five drugmakers, marking an unusually active start to a week full of global holiday celebrations. Daiichi Sankyo Co. Ltd., Astrazeneca plc, Eisai Inc., Intra-Cellular Therapies Inc. and Allergan plc all secured new approvals from the agency.
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.
BEIJING – China made strides in the CAR T space this month. The country approved two more candidates to enter clinical trials in December, and forerunner Nanjing Legend Biotech Co. Ltd. said its investigational CAR T therapy LCAR-B38M/JNJ-4528 co-developed with Janssen Biotech Inc. won FDA’s breakthrough therapy designation.
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.
PERTH, Australia – Boehringer Ingelheim GmbH is discontinuing development of BI-1467335 for the treatment of nonalcoholic steatohepatitis (NASH) that it acquired from Sydney-based Pharmaxis Ltd. in 2015.
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