Debate over Vanda Pharmaceuticals Inc.’s Hetlioz (tasimelteon) for use in jet lag disorder looks to continue after the U.S. FDA rejected the latest supplemental NDA submission, with the agency’s Center for Drug Evaluation and Research concluding the application cannot be approved in its current form.
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Akeso, Arrowhead, Curadel, GSK, Vivavision.
Clinical updates, including data readouts and publications: Bridgebio, Genfit, Gilgamesh, GSK, Hutchmed, Jazz, JJP Biologics, Monte Rosa, Pulmocide, Rezolute.
The value of biopharma deals involving nonprofit partners declined sharply over the past several years, falling to about $127.43 million in 2025 after exceeding $21.4 billion in 2021. The 2025 total also represents a steep drop from 2024’s $754.56 million.
Hutchmed Ltd. plans to file a second NDA in China for sovleplenib, a novel spleen tyrosine kinase inhibitor, based on positive phase II/III findings in warm antibody autoimmune hemolytic anemia.
Takeda Pharmaceuticals Co. Ltd.’s oral tyrosine kinase 2 inhibitor, zasocitinib (TAK-279), met the co-primary endpoints and all ranked secondary endpoints in two pivotal phase III studies in patients with moderate to severe plaque psoriasis.
There are two significant messages for companies developing and profiting from obesity drugs in a meta-analysis of clinical trials examining the extent of weight regain after treatment stops. First, people taking obesity medication regain weight four times faster on average than those who lose weight through behavioral diet and exercise programs; and second, poor tolerability leads to poor adherence.
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