Taking strides from its start as a Seoul National University laboratory, South Korea’s Cellid Co. Ltd. said July 24 that the MFDS approved an IND for the global phase III trial for its omicron variant-targeting COVID-19 vaccine called AdCLD-CoV19-1 OMI. Approval from the MFDS comes two months after Cellid filed the IND on May 23 for its adenovirus vector platform vaccine “capable of responding quickly to virus mutations,” the company said. Read More
With Aeon Biopharma Inc. listing on the New York Stock Exchange (NYSE) on July 24, South Korea’s Daewoong Pharmaceutical Co. Ltd. is seeking new territory for its beleaguered botulinum toxin (BTX) product, Nabota (Jeuveau or ABP-450 in the U.S). Aeon’s move is expected help expand Nabota beyond aesthetic treatment to include medical conditions such as episodic migraines, cervical dystonia and post-traumatic stress disorder (PTSD). Read More
South Korea’s antitrust agency on July 20 imposed fines of ₩40.9 billion (US$31.9 million) to crack down on 32 pharmaceutical firms charged with colluding on production, distribution and wholesale of vaccines in the country’s immunization program. Read More
The HIV journey is a roller coaster of highs and lows for the patients living with HIV and their families and loved ones but also for the community of researchers and clinicians who pour their hearts and souls into the work they do, said speakers at the International AIDS Society (IAS) 2023 conference in Brisbane, Australia. Read More
Artificial intelligence (AI) drug discovery specialist Insilico Medicine Inc. is progressing INS018-055, its lead compound to phase II trials for idiopathic pulmonary fibrosis, a chronic lung disease that results in progressive and irreversible decline in lung function. Read More
Nearly five years after submitting its first NDA seeking U.S. approval for Vanflyta (quizartinib) for treating a subset of patients with acute myeloid leukemia (AML), Daiichi Sankyo Co. Ltd. finally cleared the last hurdle. The FDA on July 20 approved the FLT3 inhibitor for use in combination with cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed disease that is FLT3 ITD-positive. Read More
Santen Pharmaceutical Co. Ltd. is selling its North American branded ophthalmic portfolio to Visiox Pharma LLC and Harrow Health Inc. in a move to make its global organization as competitive as possible, Santen told BioWorld. Read More
Sosei Heptares is fulfilling its ambition for growth in the Asia-Pacific region by buying the Japanese and South Korea businesses of Swiss biotech Idorsia Ltd. for ¥65 billion (US$463 million), potentially freeing Idorsia from its struggle to prove its stroke drug, Pivlaz (clazosentan), is effective enough to warrant approval in key Western markets. Read More
Kissei Pharmaceutical Co. Ltd. has withdrawn its NDA in Japan for rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Kissei, of Osaka, Japan, said it temporarily withdrew the application for marketing approval and would discuss the possibility of conducting additional clinical trials with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), because the PMDA expressed concern about the approval based on the current clinical trial data. Read More
Prestige Biopharma Ltd. is mounting efforts to rise rank through the industry with a two-pronged strategy of becoming a global cancer antibody drug developer and contract development and manufacturing organization. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Antengene, Biocity, Biogen, Gannex, Highfield, Kintor, Recce, Sathgen, Telix, Triastek, Zai. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Biontech, Biotheus, Botanix, CASI, Cleave, Fresh Tracks. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Antengene, Arrowhead, Beigene, Daiichi Sankyo, Dong-A, Fosun Kite, Hutchmed, Junshi, Mabwell, Qihan, Scynexis, SN. Read More
