Matt Hoffman

Final approval is expected by June 20, 2020, ahead of the generic erosion following the patent expiration of Biogen’s Tecfidera.

The anti-CD20 antibody showed greater reductions in Expanded Disability Status Scale scores over a decade in patients with SPMS compared to matching controls never treated with it.

The Clinical Director of the NHGRI spoke about the impact of the NIH program and its future development.

The director of the Jefferson Comprehensive Epilepsy Center and the Jefferson Clinical Neurophysiology Laboratory spoke to the therapy’s success thus far.

The position statement’s author noted that a lack of specificity in laws and inconsistencies in protocols has led to confusion surrounding brain death in several high-profile cases.

The program’s director spoke about its genesis and evolution into a more widespread initiative which has helped improve next-generation genome sequencing.

The FDA notice stated that these discontinuations are the result of a business decision by manufacturer GlaxoSmithKline.

The director of the sleep clinic and assistant professor of neurology at Harvard Medical School spoke about the state of pediatric narcolepsy management and diagnosis.

A proof-of-concept trial’s findings have shown that more clinical research into the potential neuroprotective effect of cannabinoids in slowing disease progression in motor neuron disease is warranted.

The associate professor of neurology and the director of clinical trials at the University of Florida’s Center for Movement Disorders and Neurorestoration spoke about what’s being developed in the Parkinson disease pipeline.

The founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation spoke about the exciting therapeutic landscape in Alzheimer and what holes remain.

The associate professor of neurology and the director of clinical trials at the University of Florida’s Center for Movement Disorders and Neurorestoration spoke about addressing the complex relationship between caregivers in treating tardive dyskinesia.

The agency has decided that a major amendment is needed for the therapy’s NDA and has pushed the PDUFA goal date to March 20, 2019.

The founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation spoke about the progress made in 2018, and what to look forward to in 2019.

The approval marks the first and only of its kind, with the treatment anticipated to be commercially available by prescription in the US sometime in Q1 of 2019.

A recent review of treatments for pediatric status epilepticus included a critical assessment of non-medicinals which detailed that the evidence for their use is mostly anecdotal.

Although the therapy did not achieve significance for the primary end point in the full data set, a pre-specified exploratory analysis implemented in a post-hoc framework did provide evidence of significant benefit for the 20-μg dose.

With more than a dozen disease-modifying therapies, some have set their sights on developing an agent designed to promote remyelination.

The chief of the Multiple Sclerosis Division at the Perelman School of Medicine explained how an increase in the number of MS neurologists could improve the state of care.

The trial of the mesenchymal stem cells therapy is expected to commence in early 2019.

After failing to show motor symptom improvement in patients with Huntington disease in several clinical trials, pridopidine may have hit the end of its developmental road.

Bayer’s pharmacovigilance database showed a similar rate of birth defects and spontaneous abortions in those exposed to IFN-β in comparison with available general population worldwide estimates.

The professor of neurology at the Hospital of the University of Pennsylvania and the chief of the Multiple Sclerosis Division at the Perelman School of Medicine spoke about this strategy and why it came to be.

The treatment is the first approved novel, oral once-daily extended release formulation of oxcarbazepine for the treatment of partial-onset seizures in patients aged 6 years and older.

Based on the findings, patients who are stable on their current IFN-ß therapy should remain on that therapy, but further studies are needed on when to switch therapies in multiple sclerosis.

The professor and head of the Department of Neurology and Rehabilitation at the University of Illinois at Chicago spoke about how data can better inform epilepsy care.

The treatment, previously known as retigabine, was assessed in a phase 2 trial in more than 60 patients with amyotrophic lateral sclerosis.

Although the trial was small, the findings reiterate what has previously been shown with natalizumab in larger, prior studies.

Physicians have debated whether or not cognition is a reliable marker for disease deterioration, and if it should necessitate a change in therapy.

A new analysis has suggested that an inflammatory response may be a crucial and modifiable determinant of disability accrual in progressive-onset multiple sclerosis.