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TG Therapeutics Announces Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the 2024 Consortium of Multiple Sclerosis Centers Annual Meeting

Retrieved on:

fredag, maj 31, 2024

Patient, CMSC, Therapy, Multiple sclerosis, MD, RMS, Publication, Harbor

NEW YORK, May 31, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced presentations highlighting study designs for post-marketing studies being undertaken for BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting.

Key Points:

NEW YORK, May 31, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced presentations highlighting study designs for post-marketing studies being undertaken for BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting.
Presentations are now public and can be viewed using the below links.
of California San Francisco, San Francisco, CA
Lead Author: Riley Bove, MD - UCSF Weill Institute of Neurosciences, Dept.
of California San Francisco, San Francisco, CA
Presentations are available on the Publications page, located within the Pipeline section, of the Company’s website at https://www.tgtherapeutics.com/publications/ .

TG Therapeutics Announces Schedule of Upcoming Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the 2024 Consortium of Multiple Sclerosis Centers Annual Meeting

Retrieved on:

tisdag, maj 28, 2024

Patient, CMSC, Abstract (summary), Therapy, Multiple sclerosis, MD, RMS, Publication, Harbor

NEW YORK, May 28, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of upcoming presentations highlighting study designs for post-marketing studies being undertaken for BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, being held May 29 – June 1, 2024, in Nashville, Tennessee.

Key Points:

NEW YORK, May 28, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of upcoming presentations highlighting study designs for post-marketing studies being undertaken for BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2024 Consortium of Multiple Sclerosis Centers (CMSC) annual meeting, being held May 29 – June 1, 2024, in Nashville, Tennessee.
Abstracts are now available online and can be accessed on the CMSC meeting website at www.mscare.org/2024 or by clicking on the following link: https://meridian.allenpress.com/ijmsc/article/26/s1/1/500896/Abstracts-f... .
of California San Francisco, San Francisco, CA
Lead Author: Riley Bove, MD - UCSF Weill Institute of Neurosciences, Dept.
of California San Francisco, San Francisco, CA
Presentations will be available on the Publications page, located within the Pipeline section, of the Company’s website at https://www.tgtherapeutics.com/publications/ .

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction - EU Implementation Guide

Retrieved on:

tisdag, maj 28, 2024

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction - EU Implementation Guide

Key Points:

Products Management Services - Implementation of International Organization for
Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
EMA/676106/2019
Page 3/8

1.
Introduction
The International Organisation for Standardisation (ISO) Identification of Medicinal Products (IDMP)
standards specify the use of standardised definitions for the identification and description of medicinal
products for human use.
The use of ISO IDMP standards is required in accordance with Articles 25 and 26 of Commission
Implementing Regulation (EU) No 520/2012.
Products Management Services - Implementation of International Organization for
Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
EMA/676106/2019
Page 4/8

2.
Chapters
The EU IG is composed of the following chapters available on the 'Substances and products data
management services' webpage:
Introduction ? EU Implementation Guide: Introduction and Scope of the EU IG for implementation
of ISO IDMP.
Chapter 1 ? Registration requirements: Guidance on how to get access to SPOR (Substances,
Products, Organisations and Referential Management Services).
Chapter 3 ? Process for the electronic submission of medicinal products information:
Guidance on the processes driving the submission of medicinal product information.
Products Management Services - Implementation of International Organization for
Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
EMA/676106/2019
Page 5/8

3.
These updates are reflected
Products Management Services - Implementation of International Organization for
Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
EMA/676106/2019
Page 6/8

in EU IG Chapter 2 and 8.
Products Management Services - Implementation of International Organization for
Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
EMA/676106/2019
Page 8/8

Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1

Retrieved on:

tisdag, maj 28, 2024

Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1

Key Points:

Training .................................................................................................................................................... 13
Product Management Service (PMS) - Implementation of International Organization for
Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in
Europe
EMA/676105/2019

Page 2/13

Summary of changes
Following the publication of version 2 in February 2021, the following sections were updated:
?

PMS Registration requirements;

?

Access to data;

?

Training.
Scope of this document
This document has been developed with the goal of facilitating the maintenance and accessibility to
data on medicinal products for human use in the EU.
Scope of PMS
The scope of PMS is to have harmonised data and definitions to uniquely identify a medicinal product
based on regulated information (e.g.
Therefore, users shall read this chapter in
conjunction with the 'On-boarding of users to Substance, Product, Organisation and Referentials
(SPOR) data services' document.
In order to start this process the user has to confirm the registration of the relevant organisation in
Organisation Management Service (OMS).
Product Management Service (PMS) - Implementation of International Organization for
Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in
Europe
EMA/676105/2019
Page 4/13

User can check whether the relevant organisation is in OMS by searching using 'Request Access for
Organizations' at EMA account management.
Product Management Service (PMS) - Implementation of International Organization for
Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in
Europe
EMA/676105/2019
Page 10/13

Is the user Organisation
in OMS?
For further information on how data are classified please refer to EU IG
Chapter 5 and Annex A to Chapter 5.
Product Management Service (PMS) - Implementation of International Organization for
Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in
Europe
EMA/676105/2019
Page 12/13

5.
Additional information on the location of the training materials
will be made available in future updates of this chapter.
At the time of the PMS go live foreseen in Q2 2024, users will have read-only privileges in PMS.
The
enabling of the write privileges will be released for specific set of PMS data elements at later stage in
Q4 2024.
Product Management Service (PMS) - Implementation of International Organization for
Standardization (ISO) standards for the Identification of Medicinal Products (IDMP) in
Europe
EMA/676105/2019
Page 13/13

Inotiv Reports Second Quarter Financial Results for Fiscal 2024 and Provides Business Update

Retrieved on:

onsdag, maj 15, 2024

WEST LAFAYETTE, Ind., May 15, 2024 (GLOBE NEWSWIRE) -- Inotiv, Inc. (Nasdaq: NOTV) (the “Company”), a leading contract research organization specializing in nonclinical and analytical drug discovery and development services and research models and related products and services, today announced financial results for the three months (“Q2 FY 2024”) and six months ("YTD FY 2024") ended March 31, 2024.

Key Points:

The Company completed this in-house integration in the second quarter of fiscal 2024.
Second Quarter Fiscal 2024 Financial Results (Three Months Ended March 31, 2024)
Revenue decreased 21.5% to $119.0 million in Q2 FY 2024 as compared to $151.5 million in Q2 FY 2023.
Year-to-Date Fiscal 2024 Financial Results (Six Months Ended March 31, 2024)
Revenue decreased 7.2% to $254.5 million in YTD FY 2024 as compared to $274.2 million in YTD FY 2023.
Management will host a conference call on Wednesday, May 15, 2024, at 4:30 pm ET to discuss second quarter results for fiscal 2024.

Fivetran Appoints Anjan Kundavaram as Chief Product Officer

Retrieved on:

onsdag, maj 22, 2024

Fivetran , the global leader in data movement, today announced the appointment of Anjan Kundavaram as the company’s Chief Product Officer (CPO).

Key Points:

Fivetran , the global leader in data movement, today announced the appointment of Anjan Kundavaram as the company’s Chief Product Officer (CPO).
He will report to CEO George Fraser and serve as a member of the Fivetran executive team, driving product development and strategy execution.
"Anjan’s expertise in building new product lines and driving revenue will be invaluable as we continue to expand our product offerings and serve our customers,” said Fraser.
Earlier, Anjan led the product team at RMS, where he spearheaded the development of a SaaS product line that ultimately contributed to the company's acquisition by Moody's.

EQS-News: Immunic, Inc. Reports First Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on:

fredag, maj 10, 2024

January 2024: Announced a three-tranche private placement totaling up to $240 million, with participation from select new and existing investors.

Key Points:

January 2024: Announced a three-tranche private placement totaling up to $240 million, with participation from select new and existing investors.
With these funds, Immunic expects to be able to fund its operations into the third quarter of 2025.
Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.
An archived replay of the webcast will be available approximately one hour after completion on Immunic’s website at: ir.imux.com/events-and-presentations .

CentralSquare Customers Recognized for Excellence in Public Safety, Government Operations, and Citizen Services

Retrieved on:

onsdag, maj 8, 2024

This year, CentralSquare launched two new categories to further recognize the extraordinary efforts of dispatchers and teams driving community engagement.

Key Points:

This year, CentralSquare launched two new categories to further recognize the extraordinary efforts of dispatchers and teams driving community engagement.
The Citizen Experience Award focuses on the outstanding efforts of a municipality committed to utilizing citizen portals to engage their community.
“Citizen needs are constantly evolving, but our customers are always answering the call despite challenges with funding, infrastructure, workforce, cybersecurity, and more,” said Tim Boyle, Chief Customer Officer, CentralSquare.
The group has also endorsed CentralSquare, completed numerous online references, and hosted over twenty site visits for prospective CentralSquare customers in 2023.

Mark43 Achieves Premier FedRAMP High Authorization

Retrieved on:

tisdag, maj 7, 2024

Mark43, the leading cloud-native public safety software provider today announced that it has earned the Federal Risk and Authorization Management Program (FedRAMP®) High Authorization through agency sponsorship by the United States Secret Service (USSS).

Key Points:

Mark43, the leading cloud-native public safety software provider today announced that it has earned the Federal Risk and Authorization Management Program (FedRAMP®) High Authorization through agency sponsorship by the United States Secret Service (USSS).
With this FedRAMP High Impact Level authorization and StateRAMP High authorization, public safety agencies that partner with Mark43 can be confident that they are receiving the most resilient platform on the market.
Mark43, now authorized at the FedRAMP and StateRAMP High level, has streamlined the process for agencies by eliminating the need for extensive vendor reviews.
Built on Amazon Web Services (AWS) GovCloud, Mark43 will continue to provide the premier industry-leading security controls available for public safety.

Northern Trust and EDS Selected by Cornerstone FTM for Research Management and Portfolio Construction Capabilities

Retrieved on:

tisdag, maj 7, 2024

Banking, Professional Services, Finance, Northern Trust, EDS, Data, Data science, IDS, Trust, FTM, Aggregation, RMS, CIO, Cryptocurrency

Northern Trust (Nasdaq: NTRS) announced today that Cornerstone FTM, a financial technology focused investment fund, has selected Northern Trust and its strategic partner, Equity Data Science (EDS), for Research Management System (RMS) and Portfolio Construction solutions.

Key Points:

Northern Trust (Nasdaq: NTRS) announced today that Cornerstone FTM, a financial technology focused investment fund, has selected Northern Trust and its strategic partner, Equity Data Science (EDS), for Research Management System (RMS) and Portfolio Construction solutions.
Cornerstone will also leverage Northern Trust custody and hedge fund administration services, and data visualization and ingestion capabilities from EDS.
This new collaboration highlights the continued growth momentum of Northern Trust’s Investment Data Science (IDS) product suite, of which EDS is a key partner.
“The solutions available through Northern Trust and EDS support our critical processes and decision-making from front to back office,” said Jean-Jacques Louis, CIO & Co-Founder of Cornerstone FTM.