THX-110 Shows Promise in Obstructive Sleep Apnea With Interim Phase 2a Results
June 21st 2019Four of the 7 patients exhibited significant improvement in all assessed study parameters, which included reduction in the Apnea-Hypopnea Index scale and an improvement in oxygen desaturation index, with 1 patient demonstrating mild improvement; overall THX-110 was generally well tolerated.
Cladribine Reduces MRI Lesions Across Subgroups in ORACLE-MS Study
May 28th 2019The subgroups were defined by baseline characteristics that are known to be potential modifiers of risk to conversion to clinically-definite multiple sclerosis, including age, gender, first classification of demyelinating event, presence of T1 Gd+ lesions, and number of active T2 lesions.
The State of Charcot-Marie-Tooth Disease: An In-Depth Interview With K. Florian P. Thomas, MD
May 24th 2019The Director of the Multiple Sclerosis and Hereditary Neuropathy Centers at Seton Hall-Hackensack Meridian School of Medicine shared insight into what clinicians should know about Charcot-Marie-Tooth disease.
Fingolimod Significantly Reduces Blood NfL in Relapsing-Remitting Multiple Sclerosis
May 16th 2019NfL levels were reduced during treatment with fingolimod, providing further evidence of the long-term benefit of the drug and demonstrating a greater impact of highly effective therapy in relapsing-remitting multiple sclerosis.
Teva Halts Clinical Development of Fremanezumab for Cluster Headache
April 23rd 2019A prespecified futility analysis of a phase 3 study revealed that the primary endpoint of mean change from baseline in the weekly average number of cluster headache attacks during the 4-week treatment period is unlikely to be met.
Zogenix Receives Refusal to File Letter for Dravet Syndome Treatment ZX008
April 9th 2019The FDA cited 2 deficiencies in the NDA: certain nonclinical studies were not included to allow for assessment of chronic administration of fenfluramine; and an incorrect version of the clinical data was submitted.
Huntington Disease Gene Therapy AMT-130 Wins FDA Fast Track Designation
April 8th 2019The planned phase 1/2 trial of the recombinant AAV5 vector treatment, the first one-time administered AAV gene therapy to enter clinical testing for Huntington disease, is expected to begin dosing patients in the second half of 2019.