• Eli Lilly Gets Approval for Brain Plaque Test

    • 09 April 2012
    The US Food and Drug Administration (FDA) has approved a test that would help doctors detect brain plaque to rule out Alzheimer's disease in patients, according to a Reuters report. The radioactive dye, called Amyvid, attaches to clumps of beta amyloid, a toxic protein accumulating in the brains of Alzheimer's patients. The report said doctors can see the plaque light up due to the dye on a positron emission tomography (PET) scan. Eli Lilly and Co. said the test should ...
  • Europe: European Medicines Agency Adopts Two Alzheimers Biomarkers

    Under a voluntary new scientific pathway, the European Medicines Agency (EMA) adopted two innovative biomarkers for use in the development of new medications for Alzheimers submitted by Bristol-Myers Squibb: PET amyloid imaging (positive/ negative) as a biomarker for enrichment for use in predementia AD clinical trials , and use of CSF AB 1-42 and t-tau and/or PET-amyloid imaging (positive/ negative) . The new process can lead to either a Committee for Medicinal Produ...
  • BMJ: Despite Warning, FDA Approved Higher-Dose Aricept

    An article in The British Medical Journal ( BMJ) claims the US Food and Drug Administration (FDA) approved a higher-dose version of Eisai's blockbuster Alzheimer's drug Aricept 23 (donepezil) despite the concerns of its reviewers at FDA, reports The New York Times . FDA review staff noted their concerns about the drug's safety and efficacy, according to  The Times, finding little evidence of the drug's effectiveness in a 1,400-person clinical trial, but finding...