Lindsey Shapiro on Muck Rack

Lindsey Shapiro

Austin
As seen in: BioNews Services, Flipboard, NewsBreak, Multiple Sclerosis News Today, Parkinson's News Today, Alzheimer’s News Today, ALS News Today, SMA News Today, Huntington's Disease News, Muscular Dystrophy News, Sickle Cell Disease News and
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Articles

Oral Gaucher disease therapy moves ahead with help from EU status

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By Lindsey Shapiro
| Gaucher Disease News
The European Medicines Agency has given orphan drug designation to YH35995, Yuhan Corporation‘s investigational oral therapy for Gaucher disease, following a similar decision from the U.S. Food and Drug Administration in April. Orphan drug designation is granted to medicines for rare diseases, defined in the European Union as a condition affecting fewer than 5 in 10,000 people, and in the U.S. as one affecting fewer than 200,000 people.
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Amylyx advancing ALS treatment in trial after early safety data is positive

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By Lindsey Shapiro, Marisa Wexler Verified
| ALS News Today
The lowest tested dose of Amylyx Pharmaceuticals‘ treatment candidate AMX0114 was found to be safe and well tolerated among people with amyotrophic lateral sclerosis (ALS) in an ongoing Phase 1 clinical trial. Biomarkers of nerve damage due to ALS remained relatively stable from the study’s start — a result the trial investigators believe may change with higher doses and longer treatment.
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EU regulators approve tolebrutinib, now Cenrifki, for nonreplapsing SPMS

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By Lindsey Shapiro
| Multiple Sclerosis News Today Verified
Tolebrutinib has been approved in the European Union for the treatment of secondary progressive multiple sclerosis (SPMS) for people who have not experienced a relapse in the previous two years. The medication will be sold under the brand name Cenrifki. The decision, which is in line with a positive opinion issued by a European Medicines Agency committee earlier this year, makes tolebrutinib the first treatment approved in the EU that targets disability progression in nonrelapsing SPMS.
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