A China-based manufacturer of active pharmaceutical ingredients (API) suspended producing API for the U.S. market following an FDA inspection that found “significant deviations” from good manufacturing practices at the facility.
To understand the focus of startup Insamo Inc., one need look no further than its name, which co-founder and CEO Timothy Craven described as “portmanteau of ‘internally satisfied molecules,’” highlighting its efforts to create orally administered and membrane-permeable cyclic peptides across a range of disease areas.
Less than a month after the U.S. FDA approved Sanofi SA and Regeneron Pharmaceuticals Inc.’s bestseller Dupixent (dupilumab) for treating eosinophilic esophagitis in children ages 1 to 11, the agency has approved Takeda Pharmaceutical Co. Ltd.’s Eohilia (budesonide oral suspension) for the same indication but for an older group.
Citing national security and intellectual property (IP) concerns, a bipartisan group of U.S. lawmakers is calling on three federal departments to investigate China’s Wuxi Apptec’s ties, and that of its subsidiary, Wuxi Biologics, to the Chinese Communist Party and the country’s People’s Liberation Army.
The U.S. FDA has granted Mesoblast Ltd.’s allogeneic cell therapy Revascor (rexlemestrocel-L) rare pediatric disease designation following submission of results from a clinical trial in children with hypoplastic left heart syndrome, a potentially life-threatening congenital heart condition.
The U.S. FDA issued a complete response letter to Shin Nippon Biomedical Laboratories Ltd.’s U.S. subsidiary, Satsuma Pharmaceuticals Inc., for its NDA for dihydroergotamine nasal powder (STS-101) for acute treatment of migraine, with or without aura, in adults. Shin Nippon acquired Satsuma for $220 million in April 2023 and gained rights to STS-101.
The U.S. FDA issued Astellas Pharma Inc. a complete response letter for its BLA for zolbetuximab, citing unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for claudin 18.2-targeting drug, which was recently listed in the 2024 edition of Clarivate’s Drugs to Watch.
South Korea’s GC Biopharma Corp. has gained U.S. FDA approval for its immune-deficiency plasma drug, Alyglo (immune globulin intravenous, human-stwk; IVIG-SN 10%), five months after refiling its BLA and before its PDUFA date of Jan. 13, 2024.
In efforts to strengthen cooperation between the U.S. and South Korea’s life sciences sector, industry organizations like Biocom California and KoreaBIO are helping foster cross-border collaboration as Korea looks to ramp up the so-called Bio Economy 2.0. KoreaBIO, which stands for the Korea Biotechnology Industry Organization, in its latest feat welcomed a trade delegation run by the San Diego Regional Economic Development Corp. and the World Trade Center San Diego in November 2023, helping bolster cooperation between companies in Korea and in the San Diego and Tijuana, Mexico, regions.
With the U.S. FDA giving the green light to Takeda Pharmaceutical Co. Ltd.’s Adzynma for treating a rare blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme, the company has won two approvals in two days after the FDA approved fruquintinib a day earlier.