Roche has announced that it has terminated two phase III trials of crenezumab, a monoclonal antibody targeting beta-amyloid. The trials, CREAD 1 and CREAD 2, were evaluating the agent in prodromal to mild Alzheimer’s disease. Read More
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Phase III trials in neurology – 2018 in review
January 24, 2019A dozen phase III trials in neurology were published in 2018, many of which led to FDA approvals. The following is a summary of the study results. Read More
Record number of FDA drug approvals in 2018
January 9, 2019The U.S. Food and Drug Administration approved 59 new drugs in 2018 – a 30% increase over the number approved in 2017 and a 270% increase over the low-water mark set in 2016. Only 7 of the new approvals were for drugs used in neurology; there were no approvals of psychiatric agents. Read More
Rare cases of stroke reported with alemtuzumab
December 14, 2018The U.S. Food and Drug Administration (FDA) has issued a black-box warning about a risk of stroke and arterial dissection in patients with multiple sclerosis who have been exposed to alemtuzumab (www.fda.gov/Drugs/DrugSafety/ucm624247.htm?fbclid=IwAR2eBbqp24E0J3VIk8jbUZZ5pet…). The announcement was issued on November 29, 2018 and a black-box warning was added to the U.S. product label. The Canadian product monograph had not been updated at the time of writing. Read More