Phase III
The regulatory filing puts the company alongside Vertex and CRISPR, which also await FDA approval for their SCD gene therapy.
Vedanta will use the funds to advance its lead asset VE303 in clostridioides difficile infection and support the development of another candidate in ulcerative colitis.
Govorestat failed its primary composite measure but showed signals of efficacy, leading the company to push forward with an NDA.
Eplontersen halted ATTRv-PN disease progression and improved quality of life through 66 weeks. The drug has a PDUFA date of Dec. 22, 2023.
AbbVie shared more positive results for its migraine prevention drug, Qulipta, just three days after FDA approval to expand its label.
The checkpoint inhibitor is approved for several cancers in China, but after an indefinite FDA delay last summer, BeiGene’s partner Novartis still awaits its first U.S. approval.
The leaked data show that Carvykti cuts the risk of disease relapse by 74% versus standard chemotherapy regimens.
The checkpoint inhibitor improved patient outcomes in three cancer trials, according to results presented at the AACR meeting.
A unanimous FDA committee vote supported the favorable risk-benefit profile of Innoviva’s sulbactam-durlobactam for hospital-acquired A. baumannii infections.
Between new formulations of traditional drugs nearing the market and completely novel approaches in mid-stage trials, 2023 is poised to be a pivotal year in Parkinson’s disease treatment.
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