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In the wake of twin phase 3 failures, Roche will discontinue all active trials of the antiamyloid antibody gantenerumab, the company confirmed at the Clinical Trials on Alzheimer’s Disease annual meeting in San Francisco. Read More
TauRx went big at the Clinical Trials on Alzheimer’s Disease (CTAD) annual meeting in San Francisco, insisting that its investigational anti-tau agent, hydromethylthionine mesylate (HMTM), exerted cognitive benefit and slowed brain atrophy in an ongoing phase 3 trial — despite a prior admission that a blinded study of the drug is virtually impossible. Read More
The FDA has approved Ferring Pharmaceuticals’ fecal transplant therapy Rebyota for the prevention of recurrence of C. difficile infection (CDI) in individuals that have completed antibiotic treatment for recurrent CDI. Read More
Eisai’s antiamyloid antibody lecanemab nearly eliminated amyloid brain plaques in 68 percent of Alzheimer’s (AD) patients, while modestly slowing decline on all four cognitive and functional measures in the CLARITY AD study, company executives and clinicians involved in the study said at the Clinical Trials on Alzheimer’s Disease annual meeting in San Francisco. Read More
In FDA’s ongoing efforts to clean up the accelerated approval (AA) program, the agency has withdrawn approval for an antibiotic cream that’s been on the market for 24 years without its required confirmatory trial to show that the product works. Read More
The FDA has issued a warning letter to a clinical trial site in Illinois for failing to submit an investigational new drug application (IND) before launching a clinical investigation of a combination drug-device product. Read More
Biosimilars with “skinny labeling” saved Medicare $1.5 billion over 5 years, equivalent to almost 5 percent of what the federal system spent on five pricey biologics, according to a new report in JAMA Network. Read More
The FDA is investigating reports that the osteoporosis medicine Prolia (denosumab) may cause dangerously low calcium levels in the blood of patients with advanced kidney disease, particularly those on dialysis. Read More