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Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations

Retrieved on: 
Tuesday, March 12, 2024

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      Guideline on allergen products development for
      immunotherapy and allergy diagnosis in moderate to lowsized study populations

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      Table of contents

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      Executive summary ..................................................................................... 3

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      1.

    • Specific effects ................................................................................................. 17

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      12.

    • Management for allergies may involve avoidance of the allergen, medications to relieve

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      symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.

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      Recommendations are made on the clinical development, potential study designs and safety

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      considerations for allergen products within the scope of the guideline.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      While allergen specific immunotherapy is the only known disease modifying therapy for type I allergies,

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      there is no such treatment available for type IV allergies.

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      Several guidelines applicable for allergen products are available (see section 3) and provide advice on

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      quality and clinical development according to the current knowledge.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      However, this guideline does not cover the indication of atopic dermatitis or asthma as these

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      conditions will require separate clinical trials (see Section 6).

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      In addition, the guideline does not cover medicinal allergen products manufactured using recombinant

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      DNA technology, synthetic peptides, DNA or RNA constructs and/or cell preparations as they differ

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      substantially to the allergen products as discussed above.

    • 1

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      ?

      Guideline on the clinical development of products for specific immunotherapy for the treatment

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      of allergic diseases - CHMP/EWP/18504/2006
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      Guideline on Allergen Products: Production and Quality Issues EMEA/CHMP/BWP/304831/2007

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      Guideline on process validation for finished products - information and data to be provided in
      regulatory submissions - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Corr.1

      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      ?

      Recommendations on common regulatory approaches for allergen products - CMDh/399/2019

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      4.

    • In any

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      case, a reduced validation should include all relevant manufacturing process steps that are considered
      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      product specific.

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      Diagnostic allergen products (Type I allergy)

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      A possible target indication is diagnosis of type I hypersensitivity (immediate-type allergy) by prick,

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      intracutaneous or provocation testing.

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      7.1.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      8.

    • Clinical development of products for AIT: Study design,
      efficacy and safety

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      In general, the clinical development should be performed according to current guidelines.

    • In such single trial, the suitability as a test allergen as well as the

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      dose finding for the therapeutic allergen could be investigated.

    • Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      8.2.1.

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      In general, sensitivity and specificity of the product should be determined.

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      10.2.

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      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      4.

    • Allergol Immunopathol, 1989;

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      17(2):53-65

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      Guideline on allergen products development for immunotherapy and allergy diagnosis
      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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RevSpring Announces Its Credit Card EMV Device Integration is First Application in Epic Toolbox

Retrieved on: 
Tuesday, February 6, 2024

NASHVILLE, Tenn., Feb. 6, 2024 /PRNewswire-PRWeb/ -- RevSpring, the leading provider of healthcare engagement and payment solutions, announced today its Credit Card EMV Device Integration has been listed in Epic's Toolbox for payment device integrations. The Toolbox designation indicates an integration that follows Epic's established recommended practices in a given category.

Key Points: 
  • NASHVILLE, Tenn., Feb. 6, 2024 /PRNewswire-PRWeb/ -- RevSpring , the leading provider of healthcare engagement and payment solutions, announced today its Credit Card EMV Device Integration has been listed in Epic's Toolbox for payment device integrations.
  • The Toolbox designation indicates an integration that follows Epic's established recommended practices in a given category.
  • RevSpring's Credit Card EMV Device Integration provides a secure and flexible point of service and back-office payment processing solution that seamlessly embeds into Epic.
  • In addition to the Credit Card EMV Device Integration, RevSpring has a wide range of RevSpring applications listed in Connection Hub that are designed specifically to effectively engage patients and empower staff to securely make payments.

SEO Toolbox Launch Provides Media Marketing Experts and Entrepreneurs With Search Engine Optimization Tracking and Reporting Made Easy

Retrieved on: 
Tuesday, January 30, 2024

SEO Toolbox.io, Inc. is thrilled to announce their new monthly subscription service designed to make SEO simple for C Suite marketing professionals, media agencies and independent business owners.

Key Points: 
  • SEO Toolbox.io, Inc. is thrilled to announce their new monthly subscription service designed to make SEO simple for C Suite marketing professionals, media agencies and independent business owners.
  • SEO Toolbox provides keyword rank tracking, backlink analysis, task management, connectivity to third-party systems such as Google analytics and competitor tracking.
  • The service also offers other essential data gathering and reporting features businesses of all sizes need to fully analyze the effectiveness of their website and the interactions of potential clients.
  • “This is the service I wish I had when I was working as a media and marketing executive,” concludes Sylvander.

Linux Foundation Connectivity Grows Portfolio with ISP Toolbox and Magma Projects

Retrieved on: 
Tuesday, December 19, 2023

Magma is an open-source software platform that gives network operators an open, flexible and extendable mobile core network solution and current Linux Foundation project.

Key Points: 
  • Magma is an open-source software platform that gives network operators an open, flexible and extendable mobile core network solution and current Linux Foundation project.
  • ISP Toolbox helps to empower ISP operators with products, tools, and resources to better run their business and connect more people to faster Internet.
  • "We are pleased to  welcome the addition of Magma and ISP Toolbox to the LF Connectivity portfolio, bringing even more new open source tools to more organizations across the globe."
  • "Meta is pleased to contribute its ISP Toolbox to the Linux Foundation's open-source Connectivity project, which completes the portfolio alongside Terragraph, Open M-Plane, and Maveric technologies," said Shah Rahman, Engineering Director at Meta responsible for supporting open-source Connectivity projects.

Workbox Announces New Location at Chicago's Landmark National Building, Doubling Down on The Loop's Future

Retrieved on: 
Tuesday, December 5, 2023

CHICAGO, Dec. 5, 2023 /PRNewswire/ -- Workbox, a specialized workspace operator dedicated to providing solutions and resources to early and growth stage companies, is preparing to open its doors at Chicago's historic National Building in the Loop. Targeting an early January opening, Workbox Chicago-The Loop will offer local entrepreneurs and businesses the opportunity to be a part of an unparalleled coworking community of growing companies with direct connection to over 100 capital and operating partners, programming and networking events, and vetted strategic advising from professional specialists.

Key Points: 
  • The new location will be the company's fifth in Chicago and eighth location nationwide since launching four years ago.
  • Workbox Chicago- The Loop will be located at the National Building at 123 S Clark Street, Suite 1700.
  • The National Building also features a tenant-only fitness center and a large indoor/outdoor tenant-only lounge on the 6th floor.
  • The direct access to a wide array of public transportation options makes this location convenient and accessible to everyone in the city.

Workbox Taps Timothy Doman to Lead Real Estate Initiatives & Expansion

Retrieved on: 
Thursday, October 26, 2023

CHICAGO, Oct. 26, 2023 /PRNewswire/ -- Workbox, the Chicago-based specialized workspace operator, has announced the hiring of Timothy Doman as the company's first EVP, Head of Real Estate. In this new role, Doman will leverage more than 30 years of portfolio management experience across all major real estate sectors to help accelerate Workbox's expansion plans across the United States.

Key Points: 
  • Member-driven coworking company expands leadership team with the addition of Timothy Doman as EVP, Head of Real Estate
    CHICAGO, Oct. 26, 2023 /PRNewswire/ -- Workbox , the Chicago-based specialized workspace operator, has announced the hiring of Timothy Doman as the company's first EVP, Head of Real Estate.
  • In this new role, Doman will leverage more than 30 years of portfolio management experience across all major real estate sectors to help accelerate Workbox's expansion plans across the United States.
  • He also has over a decade of institutional commercial real estate experience in portfolio management at GE Capital Real Estate and Kemper Corporation.
  • Mr. Doman received his BBA in Real Estate and Finance from the University of Wisconsin – Madison and an MBA from Indiana University.

ToughBuilt Industries Launched Innovative StackTech™ Line: A Mobile Stacking Tool Organization Ecosystem

Retrieved on: 
Tuesday, October 24, 2023

ToughBuilt entered the Stacking Tool Storage and Toolbox market for the first-time beginning October 19th, 2023, with an initial roll out of more than 25 SKUs.

Key Points: 
  • ToughBuilt entered the Stacking Tool Storage and Toolbox market for the first-time beginning October 19th, 2023, with an initial roll out of more than 25 SKUs.
  • StackTech™ is the world’s first auto-locking stacking tool storage solution with 14 unique features.
  • IRVINE, Calif., Oct. 24, 2023 (GLOBE NEWSWIRE) -- ToughBuilt Industries, Inc. ("ToughBuilt” or the Company”) (NASDAQ: TBLT; TBLTW), announced today that the Company has released its revolutionary StackTech™ mobile stacking toolbox system.
  • ToughBuilt's launch into the stacking Toolbox category has swept social media with an early preview of the product line, garnering more than 19 million impressions in just two weeks.

MathWorks Introduces Simulink Fault Analyzer and Polyspace Test in MATLAB and Simulink Release 2023b

Retrieved on: 
Thursday, September 21, 2023

MathWorks unveiled Release 2023b (R2023b) of the MATLAB® and Simulink® product families today.

Key Points: 
  • MathWorks unveiled Release 2023b (R2023b) of the MATLAB® and Simulink® product families today.
  • Simulink Fault Analyzer™ enables systematic fault effect and safety analysis using simulation.
  • Simulink Fault Analyzer helps engineers create and document formal connections between faults, hazards, fault detection and mitigation logic, and other artifacts when paired with Requirements Toolbox ™.
  • For information on all the new products, enhancements, and bug fixes to the MATLAB and Simulink product families, visit https://www.mathworks.com/products/new_products/latest_features.html .

MiniTool Unveils System Booster: Revitalize PC with This New Software

Retrieved on: 
Thursday, September 21, 2023

VANCOUVER, BC, Sept. 20, 2023 /PRNewswire/ -- MiniTool has unveiled its latest software offering: MiniTool System Booster, designed to elevate PC performance.

Key Points: 
  • VANCOUVER, BC, Sept. 20, 2023 /PRNewswire/ -- MiniTool has unveiled its latest software offering: MiniTool System Booster, designed to elevate PC performance.
  • Below are the key features and the toolbox included in MiniTool System Booster.
  • The ActiveCare feature in MiniTool System Booster can help find and fix these issues to speed up PC .
  • Users who are interested in MiniTool System Booster can try it out to optimize computer's performance.

Real Estate Center 4 Success Announces Launch of Comprehensive On-Demand Education Platform - REC4Success.com

Retrieved on: 
Wednesday, September 6, 2023

With a commitment to elevating the professional standards of the real estate industry and its agents, leading on-demand real estate education platform Real Estate Center 4 Success (REC4Success) today announced the official launch of its website REC4Success.com .

Key Points: 
  • With a commitment to elevating the professional standards of the real estate industry and its agents, leading on-demand real estate education platform Real Estate Center 4 Success (REC4Success) today announced the official launch of its website REC4Success.com .
  • It is an unparalleled and robust platform of essential tools and resources curated to advance the careers of residential and commercial real estate professionals.
  • REC4Success’s Toolbox for Real Estate Agent Success is an ever-expanding and comprehensive database of timely and essential information with real-time access to efficiency-driven topics.
  • As Broker Counsel to REBNY and appointed member of the New York State Real Estate Board, as well as certified instructor of real estate courses, he provides training programs across the country and is the creator of the Toolbox 4 Real Estate Agent Success to be an integral resource for the real estate community.