News

Bioequivalence Study of Sublingual BHV-0223 Shows Positive Results as Rilutek Substitute

A dissolving tablet version of riluzole called BHV-0223 has shown positive bioequivalence when compared to the oral form of the therapy, Rilutek, developer Biohaven Pharmaceuticals announced. The dissolving tablet, placed under the tongue, is easier to administrate to patients with amyotrophic lateral sclerosis (ALS) who have trouble swallowing. BHV-0223 also was found…

American CryoStem’s Atcell Not Approved for ALS, Other Neurodegenerative Diseases, FDA Warns

The U.S. Food and Drug Administration (FDA) has issued a warning to the American CryoStem Corporation of Monmouth Junction, New Jersey, for marketing Atcell, the company’s adipose-derived stem cell product, without FDA approval. In its warning letter, the FDA noted “significant deviations from current good manufacturing practice requirements, including some…