Multiple sclerosis

TG Therapeutics Announces European Launch of BRIUMVI® (ublituximab-xiiy)

Retrieved on: 
Monday, February 26, 2024

The launch commenced in Germany, with additional launches throughout Europe to follow.

Key Points: 
  • The launch commenced in Germany, with additional launches throughout Europe to follow.
  • In accordance with the ex-US commercialization agreement, TG Therapeutics will receive a milestone payment of $12.5 million for the first launch of BRIUMVI in a European country.
  • Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, “We want to congratulate our partner, Neuraxpharm, on the official launch of BRIUMVI in Europe.
  • TG Therapeutics entered into an agreement with Neuraxpharm (the commercialization agreement) for the ex-US commercialization of BRIUMVI® in August 2023.

Clene Reports Significant Survival Benefit With CNM-Au8® Treatment in ALS EAP Compassionate Use Programs

Retrieved on: 
Thursday, February 22, 2024

CNM-Au8 30 mg treatment was well-tolerated, without a single serious adverse event attributed to CNM-Au8, and no significant safety findings reported.

Key Points: 
  • CNM-Au8 30 mg treatment was well-tolerated, without a single serious adverse event attributed to CNM-Au8, and no significant safety findings reported.
  • A pooled survival analysis of EAP participants treated with CNM-Au8 30 mg was compared to two independent datasets derived from PRO-ACT and the ALS/MND Natural History Consortium.
  • The EAP dataset was comprised of 256 participants with ALS of which 220 EAP participants had all baseline values available for matching.
  • The Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital and Clene supported the first EAP (EAP01) launched in 2019.

ZyVersa Therapeutics Publishes New White Paper Detailing the Role of Inflammasomes and ASC Specks in Neurological Diseases, and Data Supporting Inflammasome ASC Inhibitor IC 100 as a Potential Therapeutic Option

Retrieved on: 
Thursday, February 22, 2024

A growing body of evidence supports that activation of more than one type of inflammasome contributes to development of common neurological diseases, and that extracellular ASC specks are involved in disease progression.

Key Points: 
  • A growing body of evidence supports that activation of more than one type of inflammasome contributes to development of common neurological diseases, and that extracellular ASC specks are involved in disease progression.
  • The white paper summarizes the preclinical research of leading inflammasome experts, Drs.
  • The white paper then summarizes data from preclinical research led by Drs.
  • Keane, de Rivero Vaccari, and their colleagues currently have research underway in Parkinson’s disease that was funded through a grant with the Michael J.

Ashvattha Therapeutics Announces First Patient Enrolled in Expanded Phase 1/2 Study of Imaging Agent 18F-OP-801 in Additional Neurological Indications

Retrieved on: 
Thursday, February 22, 2024

The study will evaluate the safety, pharmacokinetics and biodistribution of an intravenously administered dose of 18F-OP-801 in patients with amyotrophic lateral sclerosis (ALS), Alzheimer’s disease (AD), multiple sclerosis (MS) and Parkinson’s disease (PD).

Key Points: 
  • The study will evaluate the safety, pharmacokinetics and biodistribution of an intravenously administered dose of 18F-OP-801 in patients with amyotrophic lateral sclerosis (ALS), Alzheimer’s disease (AD), multiple sclerosis (MS) and Parkinson’s disease (PD).
  • “This study builds on preclinical data which demonstrated 18F-OP-801's ability to cross the blood-brain barrier and be taken up by activated microglia in regions of neuroinflammation in multiple disease models.
  • Additional objectives include determining the correlation between PET imaging signal, biomarkers of disease activity and clinical disease assessments.
  • The study will also assess test/retest repeatability of 18F-OP-801 uptake in a subset of subjects.

A.I. Processors for Cloud & Data Centers Forecasted to Increase to $38 Billion Dollars By 2026

Retrieved on: 
Wednesday, February 21, 2024

As AI becomes increasingly integrated into various industries, data centers must be equipped with the latest hardware to meet computational requirements.

Key Points: 
  • As AI becomes increasingly integrated into various industries, data centers must be equipped with the latest hardware to meet computational requirements.
  • Data centers underpin the remote management and orchestration of resources, enhancing operational efficiency.
  • Precedence Research continued: “Edge computing, which involves processing data closer to its source, demands decentralized data center infrastructure.
  • Data centers at the edge need to be compact, energy-efficient, and highly responsive to deliver real-time processing capabilities.

PolTREG appoints Dan Shelly as Chief Business Development Officer

Retrieved on: 
Wednesday, February 21, 2024

“I am elated we were able to attract Dan to help us deliver the promise of Treg cell therapies for a wide range of autoimmune diseases.

Key Points: 
  • “I am elated we were able to attract Dan to help us deliver the promise of Treg cell therapies for a wide range of autoimmune diseases.
  • Dr Shelly is an astute veteran of the life science industry, with a deep understanding of biology and the Treg cell therapies that PolTREG is developing.
  • He was Director of Global Business Development and Strategic Partnerships for the global non-profit PATH, where he was the Co-Lead for the COVID-19 task force.
  • So far, PolTREG has successfully treated 27 patients with PTG-007 commercially under a hospital exemption program in Poland.

TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Forum

Retrieved on: 
Tuesday, February 20, 2024

NEW YORK, Feb. 20, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of data presentations highlighting data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the upcoming Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held February 29 – March 2, 2024, in West Palm Beach, Florida.

Key Points: 
  • NEW YORK, Feb. 20, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of data presentations highlighting data from the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the upcoming Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held February 29 – March 2, 2024, in West Palm Beach, Florida.
  • Abstracts are now available online and can be accessed on the ACTRIMS meeting website at www.forum.actrims.org .
  • Details of the upcoming presentations are outlined below.
  • Lead Author: Barry Singer, MD, The MS Center for Innovations in Care - Missouri Baptist Medical Center, St. Louis, MO
    Following the presentations, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm .

Global Psoriatic Arthritis Drug Landscape Research Report 2024: Comprehensive Insights About 20+ Companies and 25+ Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 6, 2024

This report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Psoriatic Arthritis pipeline landscape.

Key Points: 
  • This report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Psoriatic Arthritis pipeline landscape.
  • A detailed picture of the Psoriatic Arthritis pipeline landscape is provided which includes the disease overview and Psoriatic Arthritis treatment guidelines.
  • The assessment part of the report embraces, in depth Psoriatic Arthritis commercial assessment and clinical assessment of the pipeline products under development.
  • Psoriatic Arthritis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Bristol Myers Squibb Announces New Data from the Long-Term DAYBREAK Study Reinforcing Efficacy and Safety of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis

Retrieved on: 
Thursday, February 29, 2024

Bristol Myers Squibb (NYSE: BMY) today announced new results from the Phase 3 DAYBREAK open-label extension trial, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced new results from the Phase 3 DAYBREAK open-label extension trial, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS).
  • In the DAYBREAK long-term extension study, treatment with Zeposia demonstrated a low annualized relapse rate of 0.098.
  • Three- and six-month confirmed disability progression was absent in 82.8% and 84.8% of participants in the trial respectively.
  • No new safety signals emerged; data from this long-term observational study of patients treated for up to 81.5 months were consistent with the established safety profile of Zeposia.

EMD Serono Presents New MAVENCLAD® Data Supporting Cognitive Function Benefits

Retrieved on: 
Thursday, February 29, 2024

The first presentation examines the stability or improvement in cognitive processing speed over a two-year period, suggesting the potential of MAVENCLAD to maintain or improve cognitive function in patients with highly active RMS.

Key Points: 
  • The first presentation examines the stability or improvement in cognitive processing speed over a two-year period, suggesting the potential of MAVENCLAD to maintain or improve cognitive function in patients with highly active RMS.
  • Additionally, interim findings from year three of the MAGNIFY-MS extension trial underscore the continued efficacy and safety profile of MAVENCLAD, which is consistent with earlier safety data.
  • These data are being presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2024.
  • The post-hoc analysis from 270 patients showed a clinically meaningful benefit in cognitive processing speed in patients treated with MAVENCLAD.