ICYMI: Why 2017 medicine approvals matter

This week, the U.S. Food and Drug Administration ’s (FDA) Center for Drug Evaluation and Research (CDER)released its 2017 New Drug Therapy Approvals report. Last year marked an extraordinary milestone for the biopharmaceutical industry and the FDA with major medicine approvals. According to the report, the FDAapproved 46 new molecular entities for a range of disease states -- the highest number of new medications in 21 years.
Source: The Catalyst - Category: Pharmaceuticals Tags: FDA Drug Development Multiple Sclerosis PDUFA New Era of Medicine Source Type: news

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Acta Neurologica Scandinavica, EarlyView.
Source: Acta Neurologica Scandinavica - Category: Neurology Authors: Source Type: research
Conditions:   Multiple Sclerosis;   Gait Disorders, Neurologic;   Cognitive Impairment Interventions:   Other: Dual-task gait;   Other: Single-task gait Sponsors:   Texas Woman's University;   TIRR Memorial Hermann;   The University of Texas Health Science Center, Houston Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Relapsing Remitting Multiple Sclerosis;   Optic Neuropathy;   Optic; Neuritis, With Demyelination Interventions:   Drug: CNM-Au8;   Drug: Placebo Sponsors:   Clene Nanomedicine;   Clene Australia Pty Ltd Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Multiple Sclerosis;   Gait Disorders, Neurologic;   Cognitive Impairment Interventions:   Other: Dual-task gait;   Other: Single-task gait Sponsors:   Texas Woman's University;   TIRR Memorial Hermann;   The University of Texas Health Science Center, Houston Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Relapsing Remitting Multiple Sclerosis;   Optic Neuropathy;   Optic; Neuritis, With Demyelination Interventions:   Drug: CNM-Au8;   Drug: Placebo Sponsors:   Clene Nanomedicine;   Clene Australia Pty Ltd Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
PMID: 29790573 [PubMed - in process]
Source: Revista de Neurologia - Category: Neurology Authors: Tags: Rev Neurol Source Type: research
Conclusions: Staff training and clinical support in the use of a structured clinical protocol for managing BPSD were linked to reductions in staff job stress, which may in turn increase staff capacity to identify indicators of resident distress and respond accordingly. Site variation in outcomes may relate to organisational and workforce-level barriers that may be unique to the RAC context and should be systematically addressed in future RCT studies of larger PND samples. PMID: 29785228 [PubMed - in process]
Source: Behavioural Neurology - Category: Neurology Authors: Tags: Behav Neurol Source Type: research
Authors: Ruet A Abstract Pediatric-onset multiple sclerosis (POMS) has distinctive features compared with adult-onset multiple sclerosis (AOMS), and warrants caution despite being a rare form of MS. POMS diagnostic criteria are somewhat different from those used in AOMS, with acute disseminated encephalomyelitis being a key differential diagnosis of MS in children. Other differential diagnoses that have to be ruled out before diagnosing MS include demyelinating syndromes, autoimmune and systemic pathologies, and infectious, genetic, metabolic and neoplastic diseases. Compared with AOMS, POMS has several different c...
Source: Revue Neurologique - Category: Neurology Tags: Rev Neurol (Paris) Source Type: research
Authors: Thouvenot E Abstract Multiple sclerosis (MS) is a complex heterogeneous disease. Diagnostic criteria are based on symptoms, biomarkers, MRI data and exclusion of differential diagnoses. Over the past few years, the usefulness of biomarkers has progressively decreased with the development of new MRI criteria, yet dozens of new biomarkers, especially in cerebrospinal fluid, for MS diagnosis and prognosis have been described. Large-scale studies validating some of these new biomarkers have also provided confirmation of a restricted set of biomarkers (presented here in this review) as having potential value fo...
Source: Revue Neurologique - Category: Neurology Tags: Rev Neurol (Paris) Source Type: research
Authors: Louapre C Abstract Magnetic resonance imaging (MRI) plays a central role in the management of patients with multiple sclerosis (MS). T2-weighted/FLAIR lesions have been included in the diagnostic criteria since 2001, and the importance of the technology has been expanded in each successive revision of the McDonald criteria. While the typical focal hyperintense lesions seen on T2 and FLAIR sequences in several areas of the central nervous system are key features for MS diagnosis, they can also be used to monitor disease activity, particularly in asymptomatic patients, and to evaluate therapeutic responses. ...
Source: Revue Neurologique - Category: Neurology Tags: Rev Neurol (Paris) Source Type: research
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