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Amgen finally launched Amjevita (adalimumab-atto) in the U.S. yesterday, releasing the first rival to AbbVie’s mega-blockbuster anti-inflammatory drug, Humira. Read More
Cassava Sciences is claiming a phase 2 win with its investigational Alzheimer’s treatment simufilam in patients with mild-moderate disease — but the open-label study lacks a placebo comparator, and the topline numbers didn’t come with context indicating their statistical validity. Read More
The FDA’s Antimicrobial Drugs Advisory Committee gave a 14-1 thumbs-up yesterday for Cidara Therapeutics’ rezafungin, an investigational injection intended to treat candidemia and invasive candidiasis in adults who have no other treatment options. Read More
In a clear sign that the FDA is raising the bar for accelerated approvals, the agency has declined to grant Accelerated Approval for donanemab — Eli Lilly’s entry into the antiamyloid antibody race — saying there isn’t enough long-term data to support such a move. Read More