Continuity

argenx Delivers on Promise to Transform Patient Expectations in Autoimmunity at American Academy of Neurology 2024 Annual Meeting

Retrieved on: 
Thursday, March 7, 2024

“We are opening a new chapter for the VYVGART portfolio,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx.

Key Points: 
  • “We are opening a new chapter for the VYVGART portfolio,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx.
  • These positive data from the ADHERE study have been submitted to the FDA for potential approval of VYVGART Hytrulo in CIDP with a PDUFA target action date of June 21, 2024.
  • Achievement of MSE enables significant quality of life improvements: ADAPT/ADAPT+ demonstrate that >40% of patients achieve minimal symptom expression (MSE) across both studies.
  • Patients achieving MSE experience quality of life outcomes comparable to healthy populations, suggesting MSE could be a primary goal of gMG treatment.

Dairy Council of California Releases Culturally Responsive Nutrition Resource for the Hispanic Community

Retrieved on: 
Wednesday, March 6, 2024

SACRAMENTO, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Dairy Council of California, a leader in nutrition education and advocacy, announced the release of a culturally responsive resource to support infant and toddler nutrition for Hispanic families.

Key Points: 
  • SACRAMENTO, Calif., March 06, 2024 (GLOBE NEWSWIRE) -- Dairy Council of California, a leader in nutrition education and advocacy, announced the release of a culturally responsive resource to support infant and toddler nutrition for Hispanic families.
  • Collaborating with dietitians and nutritionists that work with the Hispanic community, Dairy Council of California served as lead consultant to coordinate development of the critical resource.
  • This resource provides an actionable way to better reach families with culturally tailored nutrition resources that are relevant and relatable.
  • The community’s feedback on the resource has been very positive,” states Dairy Council of California CEO Amy DeLisio.

Continuity Private Wealth launches with support from LPL Strategic Wealth Services

Retrieved on: 
Tuesday, February 27, 2024

SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- LPL Financial LLC announced today that financial advisors James “Jamie” P. Debuque, CPFA®, CPWA®, CRPC™ and Timothy M. Baltz, CPFA®, CRPC™ have launched a new independent practice, Continuity Private Wealth , through affiliation with LPL Financial’s supported independence model, LPL Strategic Wealth Services .

Key Points: 
  • SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- LPL Financial LLC announced today that financial advisors James “Jamie” P. Debuque, CPFA®, CPWA®, CRPC™ and Timothy M. Baltz, CPFA®, CRPC™ have launched a new independent practice, Continuity Private Wealth , through affiliation with LPL Financial’s supported independence model, LPL Strategic Wealth Services .
  • They reported having served approximately $1 billion in advisory, brokerage and retirement plan assets* and join LPL from Merrill Lynch.
  • LPL’s Strategic Wealth Services allows advisors to do just that—to run their business on their terms and decide what’s best for their clients, all while receiving comprehensive modern services and support.
  • We look forward to supporting Continuity Private Wealth for years to come.”

Preliminary QIG Considerations regarding Pharmaceutical Process Models

Retrieved on: 
Tuesday, March 12, 2024

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Key Points: 
    • 6

      Preliminary QIG Considerations regarding Pharmaceutical
      Process Models

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      Background

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      This Quality Innovation Group (QIG) document follows on from the first QIG Listen & Learn Focus

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      Group (LLFG) on Continuous manufacturing and the second QIG LLFG on Digital novel technologies,

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      held on 13 March 2023 and 12-13 October 2023 respectively.

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      It is recognised that regulatory expectations for process models in pharmaceutical manufacturing are

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      evolving; the intent of this document is to share QIG?s current thinking with stakeholders and seek

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      their comments.

    • This, in turn, supports adoption of advanced process

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      control strategies, continuous process verification, real-time process monitoring and optimisation, and

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      automated or even autonomous operation and management of manufacturing processes.

    • Process

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      models play an increasingly important role in process design and validation, in control strategies and

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      during manufacturing process lifecycle.

    • The expected outcome from the use of process models is

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      enhanced process understanding, (multivariate) monitoring and control, robustness, performance and

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      adaptability.

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      A model (in the context of pharmaceutical manufacturing) is a mathematical representation of a

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      physical or biological process or system.

    • Empirical models (e.g., multivariate models used for Statistical Process Control, regression models

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      derived from data collected from Design of Experiments), and

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      3.

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      Scope

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      This document addresses preliminary considerations (general principles) for process models, reflecting

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      the use of performance-based approaches in pharmaceutical manufacturing processes.

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      The scope of this document is limited to process models such as first-principle models, regression

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      models, system models, multivariate statistical process control models, and Machine Learning models

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      (ML).

    • Complex datasets need not be
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      submitted.

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      EMA/90634/2024

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      151

      Of note, these are just examples.

    • Process validation for finished products ? information and data to be provided in regulatory submissions
      (EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1,Corr.1)
      Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory
      submission (EMA/CHMP/BWP/187338/2014)
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      5

      Preliminary QIG Considerations regarding Pharmaceutical Process Models
      EMA/90634/2024

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      163

      Some models may have a dual purpose e.g., used for process development and used as part of the

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      control strategy e.g., to set control limits.

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      Process validation (as described in the process validation guidelines) has an overarching role to ensure

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      that the process consistently delivers material of the intended quality.

    • Depending on the model risk, a model verification protocol may be requested,
      Preliminary QIG Considerations regarding Pharmaceutical Process Models
      EMA/90634/2024

      Page 6/7

      209

      including the model performance metrics and the manufacturing process IPC and CQAs that should be

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      followed, the respective acceptance criteria, the number of additional data (independent) that would be

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      used, and the monitoring period (parallel testing).

    • Preliminary QIG Considerations regarding Pharmaceutical Process Models
      EMA/90634/2024

      Page 7/7

MetricStream Named a Leader in Third-Party Risk Management Platforms by Independent Research Firm

Retrieved on: 
Wednesday, March 6, 2024

MetricStream , the global market leader in governance, risk, and compliance (GRC), announced today that it has been named a Leader in The Forrester Wave™: Third-Party Risk Management (TPRM) Platforms, Q1 2024.

Key Points: 
  • MetricStream , the global market leader in governance, risk, and compliance (GRC), announced today that it has been named a Leader in The Forrester Wave™: Third-Party Risk Management (TPRM) Platforms, Q1 2024.
  • After identifying the 13 most significant providers, Forrester used a 24-criterion evaluation of third-party risk management (TPRM) platform providers to research, analyze, and score them.
  • According to the report, MetricStream has oriented its strategy around cognitive innovation, offering robust features to support the third-party risk lifecycle.
  • It automates the end-to-end processes of information gathering, onboarding, real-time monitoring, risk, compliance and control assessments, and risk mitigation.

Stelo by Dexcom First Glucose Biosensor to be Cleared by FDA as Over-the-Counter

Retrieved on: 
Tuesday, March 5, 2024

DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today that the FDA has cleared Stelo by Dexcom – the first glucose biosensor that doesn’t require a prescription.

Key Points: 
  • DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring for people with diabetes, announced today that the FDA has cleared Stelo by Dexcom – the first glucose biosensor that doesn’t require a prescription.
  • There are approximately 25 million people in the U.S. living with Type 2 diabetes who do not use insulin and who can benefit from continuous glucose monitoring (CGM) technology.
  • Today, Dexcom G7 is available for them with a prescription.
  • To learn more about Stelo and do a benefits check to see if you’re eligible to get started now with Dexcom G7, visit https://www.dexcom.com/en-us/stelo .

Apple unveils the new 13- and 15-inch MacBook Air with the powerful M3 chip

Retrieved on: 
Monday, March 4, 2024

Apple® today announced the new MacBook Air® with the powerful M3 chip, taking its incredible combination of power-efficient performance and portability to a new level.

Key Points: 
  • Apple® today announced the new MacBook Air® with the powerful M3 chip, taking its incredible combination of power-efficient performance and portability to a new level.
  • View the full release here: https://www.businesswire.com/news/home/20240304158359/en/
    The new 13- and 15-inch MacBook Air soars with the powerful M3 chip, featuring a super-portable design, power-efficient performance, and all-day battery life.
  • The 13-inch MacBook Air with M3 starts at $1,099 (U.S.) and $999 (U.S.) for education, and the 15‑inch MacBook Air with M3 starts at $1,299 (U.S.) and $1,199 (U.S.) for education.
  • Apple, the Apple logo, MacBook Air, Liquid Retina, MagSafe, macOS, Final Cut Pro, Mac, FaceTime, Magic Keyboard, Touch ID, Apple Pay, iPhone, Safari, Stage Manager, AirDrop, Handoff, Freeform, iMovie, GarageBand, Pages, Numbers, Keynote, Apple Store, Apple Trade In, Apple Card, and Daily Cash are trademarks of Apple.

IRONSCALES Strengthens Executive Leadership With Appointment of Gil Mazor as Chief Product and R&D Officer, GM Israel

Retrieved on: 
Thursday, February 22, 2024

IRONSCALES , the leading enterprise cloud email security platform protecting more than 13,000 global organizations, today announced the appointment of Gil Mazor as the company's first Chief Product and R&D Officer and GM Israel.

Key Points: 
  • IRONSCALES , the leading enterprise cloud email security platform protecting more than 13,000 global organizations, today announced the appointment of Gil Mazor as the company's first Chief Product and R&D Officer and GM Israel.
  • Gil’s addition to the executive team underscores IRONSCALES' commitment to growth and innovation in the cybersecurity industry.
  • "We are thrilled to welcome Gil Mazor to the IRONSCALES team," said Eyal Benishti, CEO.
  • "His appointment reflects our commitment to strengthening our executive leadership team and driving growth and success across the cybersecurity market.

Netwrix Continues to Secure Organizations Globally by Securing Their Data, Identities and Infrastructure

Retrieved on: 
Thursday, February 29, 2024

FRISCO, Texas, Feb. 29, 2024 /PRNewswire/ -- Netwrix, a vendor that delivers effective and accessible cybersecurity to any organization, has released new versions of six products since October 2023 and expanded its offering with data loss prevention (DLP) capabilities. The enhancements further help customers face digital threats with confidence by enabling them to identify and protect sensitive data as well as to detect, respond to, and recover from attacks.

Key Points: 
  • Netwrix PolicyPak now enables organizations to solve endpoint management and protection challenges for workstations and laptops with ARM processors without affecting end-user productivity.
  • Privileged access management (PAM) solution:
    Netwrix Privilege Secure now ensures consistent control over privileges across both Microsoft SQL Server and Postgres and provides seamless database migration.
  • Netwrix Change Tracker facilitates compliance with a broad selection of new CIS Benchmarks and Compliance Reports templates.
  • "Netwrix keeps focusing on delivering strong, consistent security measures across the whole on-premises and cloud infrastructure to empower our customers to face digital threats with confidence."

Seeq Announces Generative AI Capabilities with Seeq AI Assistant

Retrieved on: 
Thursday, February 29, 2024

SEATTLE, Feb. 29, 2024 /PRNewswire/ -- Seeq, a leader in industrial analytics and AI, today unveiled the Seeq AI Assistant, a generative AI (GenAI) resource embedded across its industrial analytics platform. The Seeq AI Assistant provides real-time assistance to users across the enterprise, empowering them to accelerate mastery of the Seeq platform, build advanced analytics, machine learning, and AI skills and knowledge, and accelerate insights to improve decision making in pursuit of operational excellence and sustainability.

Key Points: 
  • SEATTLE, Feb. 29, 2024 /PRNewswire/ -- Seeq , a leader in industrial analytics and AI, today unveiled the Seeq AI Assistant, a generative AI (GenAI) resource embedded across its industrial analytics platform.
  • The Seeq AI Assistant provides real-time assistance to users across the enterprise, empowering them to accelerate mastery of the Seeq platform, build advanced analytics, machine learning, and AI skills and knowledge, and accelerate insights to improve decision making in pursuit of operational excellence and sustainability.
  • The Seeq AI Assistant provides organizations with the opportunity to further debottleneck their most precious resource – the people at the frontlines of their processes and decisions.
  • Combining these competencies with prompt engineering curated by the world-class analytics and learning engineers at Seeq, the Seeq AI assistant generates accurate and actionable suggestions for analytical approaches and techniques, code generation and more.