The U.S. FDA has approved its second treatment for an ultra-rare disease in the past three days by greenlighting Veopoz (pozelimab-bbfg) from Regeneron Pharmaceuticals Inc. Approval of the priority BLA for Veopoz, a fully human monoclonal antibody to treat Chaple disease, was announced two days ahead of its Aug. 20 PDUFA date. It is the only FDA-approved therapy for the indication. Read More
Jyong Biotech Ltd. filed for an IPO that could raise as much as $40 million to advance a pipeline that includes several prospects for urinary system disorders, including one that has reached the NDA stage in the U.S. Based in New Taipei City, Taiwan, Jyong was founded in 2002. The lead compound is MCS-2 for benign prostatic hyperplasia with lower urinary tract symptoms. Read More
South Korea’s Celltrion Inc. is rolling out a tweaked plan to merge its three affiliates – electing for a two-way merger followed by consolidation with the final branch – in its latest efforts to rise through the ranks and emerge as a “true” big pharma. Read More
Drug approvals by the U.S. FDA increased 20.48% compared to the first seven months of 2022, even with July approvals slightly down to 13 from the previous six months’ average of 14.5 per month. Worldwide approvals from January to July are down 13.8% from the same period last year. Read More
Imagion Biosystems Ltd. signed a flurry of deals recently to expand its pioneering molecular magnetic resonance imaging platform Magsense beyond Australia and into additional indications to detect cancer earlier. Read More
Research in rhesus monkeys has shown a gene therapy that enhanced activity in dopamine producing neurons in the brain was effective at stopping excessive alcohol consumption in previously addicted animals. Read More
Guests Karen Carey, BioWorld’s managing editor, and Mike Ward, Clarivate’s global head of Life Sciences and Healthcare Thought Leadership, discuss the deals, financing and M&A landscape for the first half of 2023 and how U.K. biopharmas are faring post Brexit. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 10xbio Bloom, Imbria, Immunic, Inhibikase, Minghui, Mitsubishi, Neurophth, Nextpoint, Processa, Response, Reviva. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Endo, Ibio, Innocan, Medipacific, Pardes, Scilex. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Innovent, Ipsen, Nuvectis, Regeneron. Read More
