Cadila Healthcare Ltd. (also known as Zydus Cadila) has received emergency use authorization (EUA) in India for Zycov-D, making it the world’s first plasmid DNA vaccine for COVID-19. Besides the adult population, the Drug Controller General of India’s nod has also given the South Asian country its first COVID-19 vaccine for adolescents ages 12 to 18. Read More
Suzhou Abogen Biosciences Co. Ltd.’s $700 million series C fundraising provides tailwinds for the development of its messenger ribonucleic acid (mRNA) platform. The company plans to accelerate its COVID-19 mRNA vaccine clinical trial, develop other vaccine candidates and oncology programs. Read More
Building on a March deal leveraging lipid nanoparticle (LNP) technology from Genevant Sciences Corp. to fight liver fibrosis, Takeda Pharmaceutical Co. Ltd. has signed a second agreement with the company for the development and commercialization of therapies for up to two rare liver diseases. The deal includes up to $303 million in up-front and potential milestone payments for Genevant, plus royalties on possible product sales, adding to the first deal's similarly structured $600 million package. Read More
Coherus Biosciences Inc. and partner Shanghai Junshi Biosciences Co. Ltd. continued to build their case for the anti-PD-1 antibody toripalimab, popping the lid off positive interim data from the pivotal, combination phase III study called Choice-01 in first-line advanced squamous or non-squamous non-small-cell lung cancer (NSCLC). Read More
Less than two weeks after Fibrogen Inc. received an FDA complete response letter for its hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, Evrenzo (roxadustat), Astellas Pharma Inc. and Fibrogen have won European Commission approval for the drug to treat symptomatic anemia associated with chronic kidney disease (CKD) in adults. The approval, which followed a positive CHMP opinion in June, triggered a $120 million milestone payment from Astellas to Fibrogen. In addition, Fibrogen will receive royalties on EU sales of the drug. Read More
Adlai Nortye Biopharma Co. Ltd.’s $100 million series D financing in July threw new light on the enticing prospect of targeting EP4 in prostaglandin (PGE2)-driven cancers, and a number of players are lined up in the space. Read More
PERTH, Australia – As the Delta variant of SARS-CoV-2 sweeps across the globe, drugs like Roche Holding AG’s interleukin-6 receptor inhibitor Actemra (tocilizumab) are being used, often off-label, to treat serious cases of COVID-19. That usage, however, is resulting in serious drug shortages that may leave some without treatment options. Read More
PERTH, Australia – The Australian government is investing AU$79 million (US$56.75 million) in medical research and innovation projects to develop new drugs, devices and digital health technologies through its AU$20 billion Medical Research Future Fund (MRFF). Read More
PERTH, Australia – Imugene Ltd. has closed an AU$90 million (US$64 million) placement and an AU$5 million share repurchase plan that will allow the company to progress its CAR T pipeline through 2025 and pursue a collaboration with Celgene Corp. spin-off Celularity Inc. Read More
An update from China’s NMPA clarifying registration requirements and classification methods for drug-device combination products has been welcomed by industry as the regulator seeks to keep pace with fast-moving developments in the sector. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Amerimmune, Astrazeneca, Biophytis, Coherus, Exevir, Histogen, Innocare, Innovent, Junshi, Kyowa Kirin, Mei, Nrx, Senhwa, Telix, Tiziana Life Sciences, Transcenta, Zhaoke Ophthalmology. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Adagene, Amyris, Arthrosi, Aurigene Pharmaceutical Services, Bavarian Nordic, Bionova, Dr. Reddy’s, Dyadic, Guangzhou Ruiao Biopharmaceutical Technology, Harrow Health, Iaso, Insilico Medicine Hong Kong, Kinarus, Kyan, Merck & Co., Merck KGaA, Penao, Providence, RDIF, Scancell, Senhwa, Sorrento, Telix, Therapeutic Solutions International, Wakamoto. Read More
