Seizure

Novanta completes acquisition of Motion Solutions

Retrieved on: 
Tuesday, January 2, 2024

Novanta Inc. (Nasdaq: NOVT) (“Novanta” or the "Company"), a trusted technology partner to medical and advanced technology equipment manufacturers, announced today that it has completed the acquisition of Motion Solutions.

Key Points: 
  • Novanta Inc. (Nasdaq: NOVT) (“Novanta” or the "Company"), a trusted technology partner to medical and advanced technology equipment manufacturers, announced today that it has completed the acquisition of Motion Solutions.
  • “Motion Solutions is an excellent strategic fit to Novanta.
  • Motion Solutions offers high-precision, customized precision motion subsystems and components to market-leading OEMs, largely centered on medical and life sciences applications.
  • They are a market leading business, and their team shares a passion for customers, innovation, and solving complex technical challenges,” said Matthijs Glastra, Chair and Chief Executive Officer of Novanta.

Anavex Life Sciences Provides an Update on Rett Syndrome Program

Retrieved on: 
Tuesday, January 2, 2024

NEW YORK, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders today reported topline results from the randomized, double-blind, placebo-controlled, Phase 2/3 EXCELLENCE clinical trial, which evaluated the clinical efficacy, safety, and tolerability of 30 mg ANAVEX®2-73 in 92 pediatric patients with Rett syndrome (RTT) between the ages of 5 through 17 years. Participants were randomized 2:1 (ANAVEX®2-73 [62 patients] to placebo [30 patients]) for 12 weeks, followed by a week 16 safety visit. As well, Anavex reported positive Real World Evidence (RWE) feedback from Rett syndrome patients under Compassionate Use Authorization.

Key Points: 
  • As well, Anavex reported positive Real World Evidence (RWE) feedback from Rett syndrome patients under Compassionate Use Authorization.
  • After 12 weeks, the study showed improvement on the key co-primary endpoint Rett Syndrome Behaviour Questionnaire (RSBQ), which is a detailed 45-item questionnaire for assessing multiple Rett syndrome characteristics by the patients’ caregivers.
  • As of today, some patients with Rett syndrome have been on ANAVEX®2-73-treatment for over 4 years, combined OLE and Compassionate Use Program.
  • In addition to Rett syndrome, Anavex is evaluating ANAVEX®2-73 in other neurodevelopmental disorders, including Fragile X syndrome, and in neurodegenerative disorders like Parkinson’s disease.

Longboard Pharmaceuticals Announces Positive Topline Data from the PACIFIC Study, a Phase 1b/2a Clinical Trial, for Bexicaserin (LP352) in Participants with Developmental and Epileptic Encephalopathies (DEEs)

Retrieved on: 
Tuesday, January 2, 2024

Of the 52 participants enrolled in the study, 43 participants were randomized to bexicaserin (DS=4, LGS=24, DEE Other=15) and 9 to placebo (DS=0, LGS=5, DEE Other=4).

Key Points: 
  • Of the 52 participants enrolled in the study, 43 participants were randomized to bexicaserin (DS=4, LGS=24, DEE Other=15) and 9 to placebo (DS=0, LGS=5, DEE Other=4).
  • The median number of countable motor seizures per 28-day period at baseline was 38.8 in the bexicaserin group compared to 20.8 in the placebo group.
  • Most participants (85.7%) in the bexicaserin treated group (n=35) that started the maintenance period tolerated the highest dose (12 mg).
  • 100% of the participants who completed the PACIFIC Study elected to enroll in the ongoing 52-week open-label extension study.

Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Date of authorisation: 21/06/2013, Date of refusal: 26/04/2013, Revision: 21, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Date of authorisation: 21/06/2013, Date of refusal: 26/04/2013, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Xtandi, enzalutamide, Date of authorisation: 21/06/2013, Date of refusal: 26/04/2013, Revision: 21, Status: Authorised

Human medicines European public assessment report (EPAR): Inovelon, rufinamide, Date of authorisation: 16/01/2007, Revision: 24, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Inovelon, rufinamide, Date of authorisation: 16/01/2007, Revision: 24, Status: Authorised

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Human medicines European public assessment report (EPAR): Inovelon, rufinamide, Date of authorisation: 16/01/2007, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Date of authorisation: 29/08/2008, Revision: 47, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Date of authorisation: 29/08/2008, Revision: 47, Status: Authorised

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Human medicines European public assessment report (EPAR): Vimpat, lacosamide, Date of authorisation: 29/08/2008, Revision: 47, Status: Authorised

Human medicines European public assessment report (EPAR): Lyrica, pregabalin, Date of authorisation: 05/07/2004, Revision: 62, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Lyrica, pregabalin, Date of authorisation: 05/07/2004, Revision: 62, Status: Authorised

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Human medicines European public assessment report (EPAR): Lyrica, pregabalin, Date of authorisation: 05/07/2004, Revision: 62, Status: Authorised

Human medicines European public assessment report (EPAR): Pregabalin Pfizer, pregabalin, Date of authorisation: 10/04/2014, Revision: 30, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Pregabalin Pfizer, pregabalin, Date of authorisation: 10/04/2014, Revision: 30, Status: Authorised

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Human medicines European public assessment report (EPAR): Pregabalin Pfizer, pregabalin, Date of authorisation: 10/04/2014, Revision: 30, Status: Authorised

Chicago Neurodiagnostic EEG Testing Review Portal Launched By NeuLine Health

Retrieved on: 
Wednesday, November 29, 2023

NeuLine Health (844-212-5321), a neurodiagnostic service provider, announces its expanded EEG monitoring service in Chicago, Illinois.

Key Points: 
  • McKinney, Texas--(Newsfile Corp. - November 29, 2023) - As part of its expanded service, NeuLine Health has released NeuLine X, a cloud-based electroencephalogram (EEG) review portal that provides real-time access to neurologists throughout the EEG testing process.
  • NeuLine Health specializes in EEG testing for patients with neurological-related medical conditions.
  • Unlike traditional EEG testing, which often requires a hospital stay, NeuLine Health performs these tests in the comfort of patients' homes or in medical office settings.
  • NeuLine Health offers its EEG testing services to patients all over the United States, contributing to the advancement of neurodiagnostic care.

Crossject signs ZEPIZURE® commercialization agreement for northern Europe

Retrieved on: 
Friday, December 22, 2023

Dijon, France 22 December, 2023, 07:30 CET -- Crossject (ISIN: FR0011716265; Euronext: ALCJ), a specialty pharma company developing needle-free auto-injectors for emergency situations, announces it has concluded a commercialization agreement in northern Europe for its innovative rescue therapy for epileptic seizures ZEPIZURE®, previously known as ZENEO® Midazolam, covering Germany, the UK, Denmark, Sweden, Finland and Norway.

Key Points: 
  • Under the terms of the agreement, with an undisclosed strategic partner, Crossject will receive milestone payments of up to €1 million in total, upon marketing authorizations granted in the territories.
  • Crossject will sell ZEPIZURE® with a markup that is a share of the gross margin (net sales minus cost of goods).
  • Crossject covers regulatory development costs and owns potential marketing authorizations, while Crossject’s partner controls and is responsible for all commercial costs.
  • “This agreement further progresses development of ZEPIZURE® and adds further to our commercial prospects, as we have a firm order in place in the U.S., with the Biomedical Advanced Research and Development Authority, and a commercialization agreement for Australia and New Zealand.”