Lilly’s Alzheimer’s candidate joins a club that no sponsor wants to be in, but one in which some members do get approved, albeit with less-than-ideal labeling.
The delayed review for Lilly’s donanemab sets up not just another high-stakes advisory committee for an Alzheimer’s candidate but that most precarious of FDA panels – the ones announced late in the review cycle.
(This piece is one of several Pink Sheet
Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.
Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
