Phase III
Longitudinal studies that track patients’ experiences can inform and accelerate the drug approval process for rare diseases.
The joint venture between Walgreens and Prothena to accelerate the approval of an Alzheimer’s treatment is the latest in biotech and retail chain alliances.
The French pharma drops another BTK inhibitor program from Principia and an anti-TNFa from Ablynx.
Merck and AstraZeneca are seeking broad approval for Lynparza in mCRPC regardless of BRCA status.
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.
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