Takeda Pharmaceutical Co. Ltd. has voluntarily withdrawn its U.S. BLA for its dengue fever vaccine, Qdenga (TAK-003), following discussions with the FDA centered on “aspects of data collection, which cannot be addressed within the current BLA review cycle,” the company said in a statement. Read More
Neuren Pharmaceuticals Ltd. and Acadia Pharmaceuticals Inc. have expanded their development and commercialization partnership for Daybue (trofinetide) beyond the U.S. to take the Rett syndrome treatment to the world in a deal valued at $527 million plus royalties. Read More
From Roche Holding AG to Novartis AG, bad news abounds for anti-TIGIT immunotherapies. In an SEC filing on July 11, Chinese oncology R&D firm Beigene Ltd. and Basel, Switzerland-based Novartis announced an end to their $1 billion deal to develop the former’s TIGIT immunotherapy ociperlimab, with the checkpoint inhibitor going back to Beigene. Read More
Viiv Healthcare Group’s long-acting therapies to treat human immunodeficiency virus (HIV), including cabotegravir as an oral tablet and as an injectable, have been approved by China’s NMPA, expanding the company’s presence in the sector and giving HIV patients in the country a new treatment option. Read More
Questionable efficacy, high priced and risky side effects are some words to describe Leqembi (lecanemab), the latest amyloid beta-targeting antibody approved by the U.S. FDA, Korean experts said, but none of that diminishes the profound significance of the drug for Alzheimer’s disease. Read More
On the heels of a licensing deal last week, Genequantum Healthcare Co. Ltd. has struck another deal, this time out-licensing its conjugation technology to Inxmed Co. Ltd. to support development of next-generation targeted antibody-drug conjugates (ADCs). Read More
Another collaboration between two biopharmaceutical companies in the Asia-Pacific region is adding fuel to an already heated fire for antibody-drug conjugate (ADC) development worldwide. Suzhou, China-headquartered Genequantum Healthcare Co. Ltd. and South Korea’s Aimedbio Inc. recently announced extending an existing partnership to jointly develop five ADC investigative drugs. Read More
GC Biopharma Corp., formerly Green Cross Corp., said July 17 that it refiled the BLA for its intravenous immune globulin agent Alyglo (GC-5107B; IVIG-SN 10%) to the U.S. FDA – nearly a year and a half after the regulator’s initial rejection. Read More
China’s NMPA approved Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s Enhertu (fam-trastuzumab deruxtecan) as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer. Read More
Elevar Therapeutics Inc. said that the U.S. FDA accepted its NDA for oral tyrosine kinase inhibitor rivoceranib in combination with PD-1 inhibitor camrelizumab (Airuika) as a first-line treatment for liver cancer. The FDA stamped an official PDUFA target action date of May 16, 2024. Read More
The biopharma industry experienced a notable decline in deal values and activity in June 2023, with a 48.51% decrease in deal values and a 43.62% decrease in the number of deals completed compared to the previous June. M&As, however, showed a remarkable 824.59% increase in value year over year in June, thanks to several billion-dollar transactions. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Hangzhou, Hutchmed, Reece, Sciwind. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Arrivent, Astellas, Astrazeneca, Beigene, Biontech, Hansoh, Innocare, Iveric, Lianbio, Novartis, Monopar, Silence, Sumitomo, Zhejiang Doer. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Arctic Vision, Ardelyx, Astellas, Astrazeneca, Beigene, Daiichi Sankyo, Dr. Reddy’s, Incannex, Junshi, Spinogenix, Takeda. Read More
