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.
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.
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.
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.
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.
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).
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.
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.
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.
RSS
