Matt Hoffman

The FDA announced that eszopiclone, zaleplon, and zolpidem will have a new boxed warning for rare, but serious injuries and deaths as a result of complex sleep behaviors caused by the medications.

While the overall link is only suggestive, new findings from a preliminary study have implied that there may be a link between sugar-sweetened beverage consumption and a higher disability status in MS.

The co-founder and CEO of Onera Health spoke about how Onera plans to revamp sleep diagnostics with its smart band-aid patches.

Onera’s co-founder and chief medical officer, and the associate professor at John’s Hopkins University spoke about the plans for recently raised Series A funding and how a newly developed patch system could alter the diagnostics of sleep medicine.

The chair of Applied Neuroimaging and head of Neuroimaging Sciences and Edinburgh Imaging at the University of Edinburgh spoke about what the physician community needs to know about utilizing isosorbide mononitrate and cilostazol for lacunar stroke.

Although highly efficacious DMTs have improved outcomes for a growing number of patients, the majority of people with MS are still subjected to the day-to-day consequences of the disease’s symptoms, which often have a more debilitating effect on the patient than the disease itself.

An escalating, combination dose of isosorbide mononitrate and cilostazol was shown to be well tolerated, with 72% of patients achieving full or ≥50% partial doses, the primary outcome, by the end of the 8-week treatment period.

The FDA issued a reminder that improper use of the Stryker Wingspan Stent System can result in an increased risk for stroke or mortality. The agency advises against using the system when the onset of symptoms is within 7 days or less of treatment or for the treatment of transient ischemic attacks.

NuPlasma yFFP was associated with improvements in complications of therapy, motor examination scores, mentation, behavior, and mood, and in activities of daily living in patients with Parkinson disease.

Over the course of approximately 3 years, Hammersmith Functional Motor Scale-Expanded and Upper Limb Module scores, as well as 6-Minute Walk Test distances, improved significantly in patients with SMA type 2 and type 3.

Infants with SMA—who have elevated pNF-H levels—experienced significant drops in pNF-H levels when treated with nusinersen (Spinraza, Biogen), suggestive of pNF-H’s potential as a biomarker of disease activity and treatment response.

Alder stated that it expected to receive a PDUFA action date within 74 days of the submission for eptinezumab and is planning a commercial launch of the anti-CGRP agent by early 2020.

The chief executive officer of Alder Biopharmaceuticals detailed where the intravenous anti-CGRP treatment will fit into the marketplace and how the migraine prevention therapy will make an impact in treating patients.

A review of newly implemented primary end points—pain freedom and most bothersome symptom freedom at 2 hours—used in 8 clinical trials may help to guide future migraine researchers in the design of acute treatment trials.

The designation was granted by the FDA based on the results of the largest study ever conducted with monotherapy in NMOSD, which were favorable for the anti-CD19 antibody.

In addition to efficacy end points, the WEB system was markedly safer compared to current treatments, with no primary safety end points occurring between 30 days and 1 year.

Data from the STR1VE trial have reinforced the findings from the phase 1 START trial, including inclinations of prolonged survival as well as milestone achievement never seen in the natural history of SMA.

Alder Biopharmaceuticals’ monoclonal antibody was recently submitted in a BLA to the FDA and is on pace to hit the newly crowded preventive migraine market in early 2020.

MediciNova will be moving forward with a phase 2b/3 clinical trial of the ALS therapy, also known as MN-166, in 150 patients. If successful, its data will be used to support an NDA.

Patients with multiple sclerosis who were exposed to teriflunomide during pregnancy experienced similar risks of major birth defects and spontaneous abortions to the general population’s rates of 2% to 4% and 15% to 20%, respectively.

The scale includes 11 observable characteristics of CDM1 and was established through the merging of experiences and advice from patients, caregivers, therapeutic experts, and the FDA.

The Aquestive Therapeutics product, marketed as Exservan, was previously granted an orphan drug designation in January 2018. Its NDA is supported by a number of studies which sought to confirm its bioequivalence to its reference listed drug.

The study also added to a growing base of findings which suggest that patients who have failed preventive medications prior to trial participation have lower placebo responses, which could have implications for clinical trial design.

Data from the EVOLVE-1 and EVOLVE-2 phase 3 clinical trials suggest that galcanezumab (Emgality, Eli Lilly) can maintain ≥50% responder rates equivalent to that of placebo while reducing more monthly migraine days for 5 months after halting treatment.

Results of a recent real-world study at 2 MS centers have uncovered misdiagnosis rates of 17% and 19%, with patients facing an average time of misdiagnosis of 4 years during which they may be subject to numerous risks due to improper treatment.

Over the course of 2 years, findings revealed that serum NfL levels were significantly higher in patients with evidence of disease activity compared to those with no evidence of disease activity as well as 35 age-matched healthy controls.

The chief scientific officer of the Parkinson’s Foundation spoke about the developing interest in genetic forms of Parkinson, the potential to target therapies in that direction, and how a genetic treatment is the next big stage for the field.

The PEGASUS principal investigator and Translational Neurology Head of the Interdisciplinary Brain Center at Massachusetts General Hospital and Harvard Medical School spoke about the Amylyx Pharmaceuticals product’s potential in Alzheimer.

Pembrolizumab resulted in a decrease in the detection of programmed cell death protein 1 on lymphocytes in both cerebrospinal fluid and peripheral blood, with 5 of the 8 patients displaying clinical improvement or stabilization.

Amylyx Pharmaceuticals announced the trial of the 2-drug combination is seeking to enroll 100 patients with late-stage mild cognitive impairment or dementia due to Alzheimer, with plans to complete the study in 2020.