Matt Hoffman

After almost a year on the market, post-marketing data has been suggestive of a risk of anaphylaxis and angioedema in patients who are hypersensitive to erenumab or the excipients.

Ned Sharpless, MD, the director of the National Cancer Institute, has been named to the position of acting FDA Commissioner. The announcement was made just a week after the current commissioner, Scott Gottlieb, MD, announced his plans to resign in early April.

The 2-year safety and efficacy extension of the CHANGE-MS trial ultimately showed encouraging dose-dependent effects with the 18-mg/kg dose on confirmed 12-week EDSS and 25-foot timed walk scores.

The review period for the oral CGRP receptor antagonist has been set at 10 months, with a Prescription Drug User Fee Act action date in the fourth quarter of 2019.

The chief of the Multiple Sclerosis Division at the Perelman School of Medicine discussed the importance of institutions recognizing the value a comprehensive MS clinic can provide not only to the patients but the institution itself.

The vice president of US Medical Affairs in Neurology and Immunology at EMD Serono spoke to the next steps for the oral agent and its potential to get approved by the FDA in 2019.

The chief of the Multiple Sclerosis Division at the University of Pennsylvania’s Perelman School of Medicine spoke about the need for more team-based care for patients with MS.

SEEG displayed better procedural morbidities and may have better outcomes than subdural grid electrodes, which study authors suggest should impact decision-making and lower the surgical candidacy barrier.

The Allergan product was granted Priority Review for upper limb spasticity and is expected to be decided on in the second quarter of 2019, while the lower limb indication will have its evaluation by the fourth quarter.

The vice president of US Medical Affairs in Neurology & Immunology at EMD Serono discussed the importance of having long-term and age-matched data on the use of the investigational oral agent in MS.

After showing success in older infants with SMA, risdiplam is now being evaluated in adults—something that’s never been done in a controlled trial of SMA.

The director of the probabilistic vision group and medical imaging lab at McGill University spoke about machine learning’s potential to help physicians predict MS disease progression, treatment effectiveness, and more.

The spinal cord area has shown a strong link to MS disability and can help discriminate progressive and relapsing-remitting disease subtypes, which in turn could help inform individualized treatment plans.

A pair of poster presentations regarding the use of cladribine in multiple sclerosis have shown that No Evidence of Disease Activity-3 status can be sustained up to 4 years, without any new safety signals appearing.

Data have suggested that neurologists treating MS have clearly and persistently deviated from the readily available evidence regarding DMT use, all while costs continue to rise and payers intensify efforts to control them.

A late-breaking poster has suggested that the use of disease-modifying therapy is safe in patients with MS over the age of 65, as well as that disability burden and relapse rates may be lower than believed.

The pediatric critical care medicine attending physician in the Department of Anesthesiology and Critical Care Medicine at the Children’s Hospital of Philadelphia spoke about how physicians can better address brain death in pediatric patients.

Investigators concluded that the findings are suggestive of a link between faster cognitive decline, especially frontal lobe dysfunction, in patients with Parkinson who develop levodopa-induced dyskinesia.

The PDUFA date for the novel oral fumarate has been set for the fourth quarter of 2019. If approved, Biogen plans to commercialize the product under the trade name Vumerity.

The investigators wrote that these findings are suggestive of a superior effect of natalizumab and rituximab compared with fingolimod in suppressing further disease activity in patients with RRMS who switched from interferon or glatiramer acetate due to breakthrough disease.

The findings suggested that a patient’s likelihood of taking medications systematically decreased as the probability of potential AEs occurring increased or the efficacy of treatment decreased.

If approved, eptinezumab, an Alder Biopharmaceuticals product, would become the fourth member of the CGRP class, and the only member available for quarterly infusions.

In a cohort study of 592 patients with MS, the findings were suggestive that real-world escalation approaches may be inadequate to prevent unfavorable long-term outcomes.

The professor of neurology and pediatrics at Columbia University Irving Medical Center spoke about the success of the small molecule in older infants with SMA, and about what she’s looking forward to in the future of SMA treatment.

The professor of neurology and pediatrics at Columbia University Irving Medical Center spoke about the treatment’s success thus far and its potential to treat infants with more severe disease.

A joint statement from the FDA commissioner and the director of the agency’s Center for Biologics Evaluation and Research noted the product is being offered at a variety of establishments as a treatment for conditions for which its benefits are unproven.

MMJ-001 is currently in a dose-ranging trial, with a planned study for spasticity in primary progressive MS. The trial's principal investigator spoke about how it will be assessed.

A new investigation has suggested that the Magnetic Resonance Parkinsonism Index 2.0 can accurately predict the clinical evolution toward a progressive supranuclear palsy-parkinsonism phenotype, differentiating it from Parkinson disease.

The framework consists of 2 documents that expand on the agency’s plans for its risk-based approach for describing drugs, devices, and biologics, including those designated as regenerative medicine advanced therapies.

In addition to tremor-dominant Parkinson disease and essential tremor, focused ultrasound has the potential to be used in a number of conditions, according to the chief of the Neurology Service at the Maryland VA Health Care System.