Tenecteplase

Summary of opinion: Metalyse, 14/12/2023 Positive

Retrieved on: 
Tuesday, January 2, 2024
Marketing, European Commission, Bundle branch block, AMI, Splenic infarction, Myocardial infarction, AIS, Civil service commission, Intraparenchymal hemorrhage, Medication package insert, Committee, Tenecteplase, CHMP, Dietary supplement

On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Metalyse.

Key Points: 
  • On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Metalyse.
  • The marketing authorisation holder for this medicinal product is Boehringer Ingelheim International GmbH.
  • The CHMP adopted a new pharmaceutical form and strength (5 000 units (25 mg) powder for solution for injection) together with a new indication for the thrombolytic treatment of acute ischaemic stroke in adults.
  • Metalyse 5 000 units (25 mg) powder for solution for injection:
    Metalyse is indicated in adults for the thrombolytic treatment of acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage.

Summary of opinion: Metalyse, 14/12/2023 Positive

Retrieved on: 
Saturday, December 30, 2023
Marketing, European Commission, Bundle branch block, AMI, Splenic infarction, Myocardial infarction, AIS, Civil service commission, Intraparenchymal hemorrhage, Medication package insert, Committee, Tenecteplase, CHMP, Dietary supplement

On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Metalyse.

Key Points: 
  • On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Metalyse.
  • The marketing authorisation holder for this medicinal product is Boehringer Ingelheim International GmbH.
  • The CHMP adopted a new pharmaceutical form and strength (5 000 units (25 mg) powder for solution for injection) together with a new indication for the thrombolytic treatment of acute ischaemic stroke in adults.
  • Metalyse 5 000 units (25 mg) powder for solution for injection:
    Metalyse is indicated in adults for the thrombolytic treatment of acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage.

Summary of opinion: Metalyse, 14/12/2023 Positive

Retrieved on: 
Monday, December 18, 2023
Bundle branch block, European Commission, Tenecteplase, Civil service commission, Intraparenchymal hemorrhage, Myocardial infarction, Medication package insert, CHMP, AMI, Marketing, AIS, Committee, Splenic infarction, Dietary supplement

On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Metalyse.

Key Points: 
  • On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Metalyse.
  • The marketing authorisation holder for this medicinal product is Boehringer Ingelheim International GmbH.
  • The CHMP adopted a new pharmaceutical form and strength (5 000 units (25 mg) powder for solution for injection) together with a new indication for the thrombolytic treatment of acute ischaemic stroke in adults.
  • Metalyse 5 000 units (25 mg) powder for solution for injection:
    Metalyse is indicated in adults for the thrombolytic treatment of acute ischaemic stroke (AIS) within 4.5 hours from last known well and after exclusion of intracranial haemorrhage.

Genentech Announces Industry-Leading Brain Health Research Collaborations and Latest Data Across Neuroscience Medicines at AAN 2023 Annual Meeting

Retrieved on: 
Monday, April 24, 2023
Mental Health, Health, Telemedicine, Virtual Medicine, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, DSM-IV codes, Spinal muscular atrophy, Survival, Multiple sclerosis, Science, Patient, Nervous system, Ageing, Policy, IHME, Disease, Maintenance, Cleveland Clinic, University, Disability, Cardiovascular disease, Dementia, Brain, NMOSD, Research, Satralizumab, RO, RMS, RRMS, Cleveland, Immunodeficiency, Phase, Death, Safety, Huntington's disease, Abstract, Natural history, COVID-19, Multimedia, ROG, Brainpower, Neuroscience, Myasthenia gravis, Cancer, EMPOWER, Angelman syndrome, SMA, Experience, Telehealth, Partnership, Central nervous system, AAN, American Academy, Digital technology, Annual general meeting, Neuromyelitis optica spectrum disorder, Tenecteplase, AD, Pharmaceutical industry, Medical imaging, Risdiplam, Genentech

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is announcing three new partnerships focused on improving brain health outcomes.

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is announcing three new partnerships focused on improving brain health outcomes.
  • “With that in mind, we are committed to developing and delivering new medicines that address areas of highest need in neuroscience.
  • See AAN oral presentation details on Genentech’s telehealth pilot with Cleveland Clinic here , Tuesday, April 25 at 3:54 p.m.
  • To meet the needs of people living with brain health conditions, Genentech is continuing to grow and advance its pipeline, with key areas of focus in neuroimmunologic, neuromuscular, neurodegenerative and neurodevelopmental diseases.

Update on Acticor Biotech's clinical developments with glenzocimab in the treatment of cardiovascular emergencies

Retrieved on: 
Monday, January 9, 2023
Biotechnology, Pharmaceutical, Health, Cardiology, University, Hospital, IRB, Alteplase, AP, Type, University Hospitals Birmingham NHS Foundation Trust, Agence nationale de sécurité du médicament et des produits de santé, Partnership, Marketing, Assistance Publique–Hôpitaux de Paris, Stroke, Infarction, ISIN, RHU, Biologics license application, European Medicines Agency, Death, Quality of life, Pulmonary embolism, BLA, EVT, Sri Jayadeva Institute of Cardiovascular Sciences and Research, TNK, EMA, Agence nationale de la recherche, FDA, MRS, Disability, Tenecteplase, IRAS, Șaeș, Reperfusion, Standard of care, Safety, IPO, Modified Rankin Scale, Patient, Thrombectomy, Myocardial infarction, GREEN, Pharmaceutical industry, Medical imaging

ACTICOR BIOTECH (ISIN: FR0014005OJ5 - ALACT), a clinical-stage biotechnology company focused on the development of innovative drugs for the treatment of cardiovascular emergencies, in particular stroke, today provides an update on the progress of its clinical programs with glenzocimab, its lead drug candidate.

Key Points: 
  • ACTICOR BIOTECH (ISIN: FR0014005OJ5 - ALACT), a clinical-stage biotechnology company focused on the development of innovative drugs for the treatment of cardiovascular emergencies, in particular stroke, today provides an update on the progress of its clinical programs with glenzocimab, its lead drug candidate.
  • We have fully met our patient enrollment goals in 2022 and are involving new countries and hospitals in 2023.
  • We look forward to continuing the clinical development of glenzocimab in the treatment of myocardial infarction in partnership with the University of Birmingham (UK).
  • The recognition of this pivotal study design supports a future application for marketing authorization for glenzocimab in stroke in Europe.

Global Acute Ischemic Stroke Drug Pipeline Market Research 2022: Comprehensive Insights About 35+ Companies and 35+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Thursday, August 25, 2022
Neurology, Stem Cells, Pharmaceutical, Managed Care, Health, Medical Devices, Genetics, Clinical Trials, Mortality, Threonine, AIS, Tenecteplase, Ministry, NDA, Technology, Human, Safety, Plasmin, Clinical trial, Tissue plasminogen activator, TPA, Glutamine, Death, Bleeding, Cerebral infarction, Half-life, Antioxidant, Stroke, Organic acid, Disability, Fibrin, Therapy, Edema, News, III, TNK, Asparagine, Acquisition, Discovery, Oxidative stress, Ministry of Health and Welfare (Taiwan), NMDA, Patient, Dietary supplement, Pharmaceutical industry, Health

This "Acute Ischemic Stroke - Pipeline Insight, 2022" report provides comprehensive insights about 35+ companies and 35+ pipeline drugs in Acute Ischemic Stroke pipeline landscape.

Key Points: 
  • This "Acute Ischemic Stroke - Pipeline Insight, 2022" report provides comprehensive insights about 35+ companies and 35+ pipeline drugs in Acute Ischemic Stroke pipeline landscape.
  • A detailed picture of the Acute Ischemic Stroke pipeline landscape is provided which includes the disease overview and Acute Ischemic Stroke treatment guidelines.
  • The assessment part of the report embraces, in depth Acute Ischemic Stroke commercial assessment and clinical assessment of the pipeline products under development.
  • The companies which have their Acute Ischemic Stroke drug candidates in the most advanced stage, i.e.

iSchemaView’s RAPID™ Imaging Platform Chosen for Patient Selection in TIMELESS Trial

Retrieved on: 
Wednesday, February 6, 2019
Health, Cardiology, Clinical trials, Medical devices, Radiology, RTT, Stroke, Tissue plasminogen activator, Magnetic resonance imaging, Tenecteplase

Stroke is the third leading cause of death and primary cause of long-term disability in the United States.

Key Points: 
  • Stroke is the third leading cause of death and primary cause of long-term disability in the United States.
  • The TIMELESS trial is designed to evaluate whether tenecteplase is safe and effective for use in AIS when administered between 4.5 and 24 hours after stroke onset.
  • Unique in the comprehensive depth and range of its clinical validation, RAPID is now also the imaging standard in stroke research.
  • Installed in over 1,000 stroke centers, iSchemaViews RAPID (automated CTP, MRI, CTA and ASPECTS), with enhanced AI framework, is the most advanced stroke imaging platform.