Category: Uncategorised

The U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorisation for Fujirebio Diagnostics’ Lumipulse® G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic (IVD) test for the assessment of β-Amyloid pathology in patients being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline. The test, which was granted Breakthrough Device Designation by the FDA, is…

Ipsen receives positive opinion in Europe for Dysport® in the management of urinary incontinence in adults with neurogenic detrusor overactivity due to Multiple Sclerosis or Spinal Cord Injury Submission based on data from the pivotal international Phase III CONTENT clinical programme, also recently published in European Urology1 CONTENT showed that Dysport® decreased incontinence episodes, detrusor pressure and increased…

Study is first to investigate the neural hallmarks of co-occurring chronic pain and trauma in veterans, finding high, medium, and low symptom groups        Chronic pain and trauma often co-occur. However, most previous research investigated them in isolation and using subjective measures such as surveys, leading to an incomplete picture. A new study in Frontiers…

Janssen was disappointed with the recent decision (27/5/22) by the National Institute for Health and Care Excellence (NICE) on their Final Appraisal Determination, in which SPRAVATO®▼ (esketamine) nasal spray has not been recommended for use within its marketing authorisation, in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI),…

Sleepio is recommended as a cost saving option for treating insomnia and insomnia symptoms in primary care for people who would otherwise be offered sleep hygiene or sleeping pills. For people who may be at higher risk of other sleep disorder conditions, such as in pregnancy, or in people with comorbidities, a medical assessment should…

PTC Therapeutics, Inc. announced on May 20th that Upstaza™ (eladocagene exuparvovec; PTC-AADC) received a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Once ratified by the European Commission, Upstaza will be the first approved disease-modifying treatment for aromatic L-amino acid decarboxylase (AADC) deficiency for patients…

JAMA Neurology publishes Phase 3 study results on the efficacy and safety of FINTEPLA®▼(fenfluramine) oral solution for the treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) Primary endpoint was met demonstrating that fenfluramine, as adjunctive treatment, is effective in significantly reducing the frequency of drop seizures in LGS patients compared to placebo1 LGS is a…

ULTOMIRIS® (ravulizumab-cwvz) Met Primary Endpoint in CHAMPION-NMOSD (Neuromyelitis Optica Spectrum Disorder) Phase III Trial Positive high-level results from the open-label Phase III CHAMPION-NMOSD trial showed that ULTOMIRIS®(ravulizumab-cwvz) achieved a statistically significant and clinically meaningful reduction in the risk of relapse in adults with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD) compared to the external placebo…