FDA Places Hold on Approval Request for Nurtec, Sublingual Version of Riluzole

Concerns over an active pharmaceutical ingredient used in a 2017 study of Nurtec (riluzole) as a bioequivalent medicine were voiced by the U.S. Food and Drug Administration (FDA) in its response to a request for the treatment’s approval for  amyotrophic lateral sclerosis (ALS), its developer, Biohaven Pharmaceuticals,…

In 2010, a few short months after my ALS diagnosis, I found myself having to rely full time on a rollator. I’ll be the first to admit I wasn’t happy at all. But now, nine years later, it’s become my ever-present silent buddy, and I can’t imagine my life…

Patient enrollment is now complete, ahead of schedule, for the Phase 3 ORARIALS-01 clinical trial assessing the effectiveness of Orphazyme’s investigational therapy arimoclomol in the treatment of amyotrophic lateral sclerosis (ALS). “The completion of enrollment for Orphazyme’s pivotal ALS trial is another great milestone for our clinical development program. We are confident that…

Mallinckrodt Pharmaceuticals has shut down its Phase 2b PENNANT clinical trial assessing the effectiveness and safety of H.P. Acthar Gel, an experimental injectable therapy for amyotrophic lateral sclerosis (ALS). The reason for this decision was an increased incidence of pneumonia among ALS patients receiving H.P. Acthar Gel compared to…

This year for Father’s Day, I ordered a basket of gourmet caramel apples from Amy’s Candy Kitchen, a little shop in Cedarburg, Wisconsin. Amy’s Granny Smith apples are large and covered with sweet caramel, salty pecans, or other nuts. It is an explosion of flavor, magnifying both the…

A new international consortium based in Paris, and funded largely by the 28-member European Union, intends to speed the diagnosis of rare diseases, while also accelerating the development of treatments for the 95% of such illnesses that currently don’t have one. The European Joint Programme on Rare Diseases (EJP…

Lately, I’ve been on alert trying to avoid sticky points. These are what I call particular points in my day when I’m most vulnerable to distractions. Because if I give in to the distraction, I end up lost in negative thoughts and I weaken the positive mindset I’ve created to…