FDA Issues Final Policy Framework for RMAT Designated Therapies
February 18th 2019The framework consists of 2 documents that expand on the agency’s plans for its risk-based approach for describing drugs, devices, and biologics, including those designated as regenerative medicine advanced therapies.
Neuromodulation and Stimulation Devices Offer Additional Options to Patients With Headache Disorders
February 18th 2019As many patients with migraine and other disorders are resistant to currently available options, this increase in device development has brought forward additional path­ways to treatment for patients.
Focused Ultrasound Has Widespread Potential to Treat Movement Disorders
February 18th 2019In addition to tremor-dominant Parkinson disease and essential tremor, focused ultrasound has the potential to be used in a number of conditions, according to the chief of the Neurology Service at the Maryland VA Health Care System.
Pouya Ghaemmaghami, PhD: Predicted Gene Expression and the Association with Sleep Macrostructure
February 17th 2019Preliminary results show that the whole genome information can be used to assess the association between predicted gene expression in different parts of the brain and sleep, suggesting where brain genes are expressed matter for variability in sleep.
Could Vitamin D Be Leveraged as a Way to Treat Adrenoleukodystrophy?
February 15th 2019The assistant professor of neurology at Stanford University addressed the possibility that vitamin D’s role on cells within the human immune system could have a therapeutic influence in neuro-metabolic disorders such as ADL.
Drawing on Blood for Biomarkers of Alzheimer Disease
February 15th 2019The new funding initiatives and innovative programs to expedite research efforts could hasten the search for biomarkers of Alzheimer disease in the blood and, ultimately, open the door to easier, quicker, and more affordable diagnostic methods.
Focused Ultrasound Provides Patients With Tremor-Dominant Parkinson An Option Outside of DBS
February 15th 2019The professor of neurology and chief of the Neurology Service at the Maryland VA Health Care System spoke about the impact focused ultrasound has had in the treatment of tremor-dominant Parkinson disease.
Cannabis-Derived MS, Huntington Treatments Submitted to FDA for Fast Track, Orphan Drug Status
February 14th 2019MMJ International Holdings’ 2 cannabis-derived treatments, MMJ-001 and MMJ-002, were submitted for Fast Track and Orphan Drug designations, respectively, the latter of which was approved by the FDA.
Rituximab Highly Efficacious in Myasthenia Gravis, Especially in MuSK Positive Patients
February 13th 2019At the final follow-up at an average of 20 months, remission was present in 42.9% of the 56 patients included, and an additional 25% had minimal manifestations or better as measured by the Myasthenia Gravis Foundation of America-Postintervention Status.
Joseph Sullivan, MD: Efficacy of ZX008 in Dravet Syndrome
February 12th 2019The director of the Pediatric Epilepsy Center at UCSF Benioff Children’s Hospital discussed the efficacy profile of ZX008, for which Zogenix recently submitted a new drug application to the FDA for the treatment of Dravet syndrome.
FDA Issues Warnings About Dietary Supplements Claiming to Treat, Cure Alzheimer Disease
February 11th 2019A number of warning and online advisory letters were issued to 17 companies selling almost 60 products claiming to prevent, treat, or cure Alzheimer disease, among a number of health conditions.
Late-Window Thrombectomy Shows Benefit for Transferred Patients with Ischemic Stroke
February 10th 2019The investigators concluded that these findings have implications which suggest that transferring patients for late-window thrombectomy is associated with substantial clinical benefits and should be strongly encouraged.