Alnylam Pharmaceuticals recently completed enrollment in the phase 3 HELIOS-A clinical trial of the drug.
Results from one of the first multi-case studies of neurologic manifestations of COVID-19 demonstrate complex CNS involvement and raise further questions about pathological mechanism.
The first presumptive case of acute necrotizing encephalopathy in a patient with confirmed COVID-19 has been published in the journal Radiology.
The FDA has moved the PDUFA date for risdiplam back to August 24, 2020, as the agency works to review additional data that was made available from part 2 of the pivotal SUNFISH trial.
Although the drug requires no CYP2C9 genotyping or first-dose observation, an up-titration scheme should be used due to the risk of transient cardiac conduction issues.
Disease-modifying therapies used to treat several immune-mediated disorders in neurology may make patients more susceptible to the novel coronavirus.
The investigational MS therapy is currently under review with the FDA, with a PDUFA date set for June 2020.
The novel B-cell therapy has been assigned a PDUFA date of June 2020.
The latest generic entry comes on the heels of a new report from ICER, which published a list of prescription drugs that had substantial price increases in 2017 and 2018 without what they consider to be new supporting evidence.
"Mind Moments," a podcast from NeurologyLive, brings you an exclusive interview with Fred Rincon, MD, MSc.