European Commission Approval of ZTALMY® (ganaxolone) for the Adjunctive Treatment of Epileptic Seizures Associated with CDKL5 Deficiency Disorder 31 July 2023: Marinus Pharmaceuticals announced that the European Commission (EC) has granted approval of ZTALMY® (ganaxolone) oral suspension for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to…
AI enhances clinical decision-making in radiology
AI solution will help improve patient outcomes by providing timely and accurate detection of critical abnormalities Milton Keynes University Hospital NHS Foundation Trust (MKUH) will use Qure’s qER for automating the detection of critical and life-threatening abnormalities in head CT scans, including intracranial haemorrhages (ICH) caused by trauma, accidents or strokes. It is an FDA…
Positive CHMP opinion for multiple sclerosis biosimilar natalizumab
July 24, 2023 — Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion for marketing authorisation for first-of-a-kind biosimilar natalizumab developed by Polpharma Biologics. The authorisation covers treatment as a single disease-modifying…
SPRAVATO® for adults with treatment-resistant major depressive disorder
Findings presented at Royal College of Psychiatrists International Congress (RCPsych 2023) confirm the importance of SPRAVATO® as a therapeutic option for adults with treatment-resistant major depressive disorder in patients with 2 and >3 prior treatment failures.1 10 July 2023: The Janssen Pharmaceutical Companies of Johnson & Johnson announced further findings from the ESCAPE-TRD study. Data…
Improvements in treatment of intracranial aneurysms
Meta-analysis shows fewer complications and higher occlusion rates for ruptured wide-neck intracranial aneurysms, using Rapid Medical’s COMANECI™ Embolisation Assist Device 19 July 2023: Rapid Medical™, developer of advanced neurovascular devices, has announced new clinical data showing significant advantages of its novel COMANECI™ embolisation assist device over established techniques to treat ruptured wide-neck intracranial aneurysms. A recent meta-analysis…
Subcutaneous Ocrevus injection – OCARINA II trial results
Phase III trial results could strengthen Ocrevus’s position in multiple sclerosis GlobalData, 19th July 2023: Genentech recently announced positive results from its phase III trial, OCARINA II (NCT05232825), investigating the efficacy of Ocrevus (ocrelizumab) as a subcutaneous injection, administered twice yearly for ten minutes, in patients diagnosed with relapsing multiple sclerosis (RMS) and primary progressive…
Digital biomarker platform for early and differential diagnosis of Parkinson’s disease
BrainTale has been developing non-invasive, accessible, effective and clinically validated measurement and prediction tools for patients suffering from brain diseases BrainTale, a medtech deciphering white matter to enable better brain care, presented preliminary results demonstrating the effectiveness of its digital biomarker platform for the early and differential diagnosis of Parkinson’s disease. Results were presented during…
Buntanetap in PD faces challenges despite phase III progress
Annovis Bio recently received a positive safety review for the Phase III trial of buntanetap in patients with early Parkinson’s Disease (PD) (NCT05357989) from the Data and Safety Monitoring Board (DSMB). Should buntanetap demonstrate good efficacy and safety profiles in the trial, it could be the first α-synuclein-targeting product to enter the market and one…
Concussion guidance for teachers and parents
N-ABLES produces ‘Return-to-School’ concussion guide Easy-to-use, concise guidance for the return-to-school (RTS) following concussion has been produced by UKABIF National Acquired Brain Injury Learning and Education Syndicate (N-ABLES). This two-page document entitled ‘Concussion Return-to-School Guidance’ reiterates the staged return-to-education advocated in the Government’s new grassroots sports guidance but is aimed directly at teachers and parents…
