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G. Caleb Alexander, MD, MS

Alexander is a professor of epidemiology and medicine at Johns Hopkins Bloomberg School of Public Health, founding codirector of the Center for Drug Safety and Effectiveness and principal investigator of the Johns Hopkins FDA Center of Excellence in Regulatory Science and Innovation.
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Most recent by G. Caleb Alexander, MD, MS

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January 12, 2022
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Medicare proposal would limit Aduhelm coverage to those enrolled in clinical trials

CMS has proposed a National Coverage Determination decision memorandum specifying “coverage with evidence development” for FDA-approved monoclonal antibodies targeting amyloid for treating Alzheimer’s disease.

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November 18, 2021
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AAN: Neurologists must discuss Aduhelm risks with patients, families

The American Academy of Neurology has issued ethical guidance on Aduhelm that outlines important points for neurologists to communicate to patients eligible for the treatment.

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August 24, 2021
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Q&A: Use of amyloid surrogate endpoint in Aduhelm approval sets ‘dangerous’ precedent

The FDA approval of Aduhelm, which was based on beta amyloid as a surrogate endpoint, represented a “regulatory failure,” according to members of an advisory committee convened by the FDA in November 2020.