AIT

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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Key Points: 
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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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Zebra Technologies Announces Fourth-Quarter and Full-Year 2023 Results

Retrieved on: 
Thursday, February 15, 2024

Fourth-quarter 2023 gross profit was $448 million compared to $685 million in the prior year.

Key Points: 
  • Fourth-quarter 2023 gross profit was $448 million compared to $685 million in the prior year.
  • Gross margin decreased to 44.4% for the fourth quarter of 2023 compared to 45.6% in the prior year.
  • Operating expenses decreased in the fourth quarter of 2023 to $374 million from $425 million in the prior year.
  • Adjusted operating expenses decreased in the fourth quarter of 2023 to $312 million from $364 million in the prior year.

Consortium including Eco Wave Power, Toshiba, Hitachi Energy, and UK Universities Secure £1.5 Million Grant to Develop Wave-Powered Microgrid for Island in Thailand

Retrieved on: 
Thursday, February 8, 2024

TEL AVIV, Israel, Feb. 8, 2024 /PRNewswire/ -- Eco Wave Power Global (Nasdaq: WAVE) ("Eco Wave Power" or the "Company" or "EWP"), a leading, publicly traded onshore wave energy company, is pleased to announce that  it has won a £1.5 million grant (the "Grant") as part of a consortium led by Toshiba (U.K.) and Aquatera (U.K.) to design a pilot microgrid project for a remote island in Thailand.

Key Points: 
  • The £1.5 million grant is part of Innovate UK's Energy Catalyst program Round 10, which supports U.K. and international businesses and organizations in developing market-focused technologies that provide clean, affordable and accessible energy..
  • The consortium will utilize the onshore Wave Energy Converters (WECs) developed by EWP and implement advanced technology developed by the corporate partners and the university teams.
  • Professor Guang Li, of the University of Manchester, said: "This is a second grant from Innovate UK for the development and commercialization of the Eco Wave Power's technology.
  • I also believe with our great partners we can achieve all of our objectives in this project".

Consortium including Eco Wave Power, Toshiba, Hitachi Energy, and UK Universities Secure £1.5 Million Grant to Develop Wave-Powered Microgrid for Island in Thailand

Retrieved on: 
Thursday, February 8, 2024

TEL AVIV, Israel, Feb. 8, 2024 /PRNewswire/ -- Eco Wave Power Global (Nasdaq: WAVE) ("Eco Wave Power" or the "Company" or "EWP"), a leading, publicly traded onshore wave energy company, is pleased to announce that  it has won a £1.5 million grant (the "Grant") as part of a consortium led by Toshiba (U.K.) and Aquatera (U.K.) to design a pilot microgrid project for a remote island in Thailand.

Key Points: 
  • The £1.5 million grant is part of Innovate UK's Energy Catalyst program Round 10, which supports U.K. and international businesses and organizations in developing market-focused technologies that provide clean, affordable and accessible energy..
  • The consortium will utilize the onshore Wave Energy Converters (WECs) developed by EWP and implement advanced technology developed by the corporate partners and the university teams.
  • Professor Guang Li, of the University of Manchester, said: "This is a second grant from Innovate UK for the development and commercialization of the Eco Wave Power's technology.
  • I also believe with our great partners we can achieve all of our objectives in this project".

AIT Worldwide Logistics Finalizes Lubbers Logistics Group Acquisition

Retrieved on: 
Tuesday, February 6, 2024

AIT Worldwide Logistics, a leading provider of global supply chain solutions, has completed its acquisition of Lubbers Logistics Group, a European logistics company specializing in high-value, complex, and time-sensitive transport services.

Key Points: 
  • AIT Worldwide Logistics, a leading provider of global supply chain solutions, has completed its acquisition of Lubbers Logistics Group, a European logistics company specializing in high-value, complex, and time-sensitive transport services.
  • The deal, first announced on Nov. 17, 2023 , expands AIT’s global reach and enhances its offerings in the road transport and energy logistics sectors.
  • View the full release here: https://www.businesswire.com/news/home/20240206024730/en/
    With the finalized acquisition of Lubbers Logistics Group, more than 350 new teammates in 18 offices join AIT's European network (Graphic: Business Wire)
    Headquartered in Schoonebeek, Netherlands, and with more than 350 employees working across nine road transport hubs and nine freight locations, the Lubbers acquisition further expands AIT’s extensive European network.
  • In the past two months, AIT also acquired Mach II Shipping Ltd and Global Transport Solutions Group .

AIT Worldwide Logistics Acquires Global Transport Solutions Group

Retrieved on: 
Thursday, February 1, 2024

AIT Worldwide Logistics, one of the world’s leaders in global supply chain solutions, has acquired Global Transport Solutions Group (GTS), a prominent international freight forwarder specializing in time-critical marine spare parts logistics.

Key Points: 
  • AIT Worldwide Logistics, one of the world’s leaders in global supply chain solutions, has acquired Global Transport Solutions Group (GTS), a prominent international freight forwarder specializing in time-critical marine spare parts logistics.
  • AIT Chairman and Chief Executive Officer, Vaughn Moore, said, “I’d like to welcome our new GTS teammates to the global AIT network.
  • The deal also provides a strong foundation to expand GTS’ world-class marine spare parts solutions via AIT’s expansive global freight network.
  • “GTS will gain enormous benefits from leveraging the global AIT infrastructure, creating an even more integrated and seamless solution for clients around the world.”
    Terms of AIT’s agreement to acquire Global Transport Solutions Group have not been disclosed.

Applied Industrial Technologies Reports Fiscal 2024 Second Quarter Results

Retrieved on: 
Thursday, January 25, 2024

Applied Industrial Technologies (NYSE: AIT), a leading value-added distributor and technical solutions provider of industrial motion, fluid power, flow control, automation technologies, and related maintenance supplies, today reported results for its fiscal 2024 second quarter ended December 31, 2023.

Key Points: 
  • Applied Industrial Technologies (NYSE: AIT), a leading value-added distributor and technical solutions provider of industrial motion, fluid power, flow control, automation technologies, and related maintenance supplies, today reported results for its fiscal 2024 second quarter ended December 31, 2023.
  • Results include a tax benefit of $3.0 million, or $0.08 per share, from a deferred tax valuation allowance adjustment.
  • Neil A. Schrimsher, Applied’s President & Chief Executive Officer, commented, “I’m encouraged by our second quarter results considering normalization of industrywide end-market activity.
  • Updated adjusted EPS guidance excludes the $3.0 million tax benefit in the fiscal 2024 second quarter related to a deferred tax valuation allowance adjustment.

AIT Worldwide Logistics Opens State-of-the-Art Facility in Chicago Suburbs

Retrieved on: 
Tuesday, January 23, 2024

AIT Worldwide Logistics, a leading global logistics provider, is proud to announce the opening of its all-new AIT-Chicago office and warehouse, a LEED-certified facility in Palatine, Illinois.

Key Points: 
  • AIT Worldwide Logistics, a leading global logistics provider, is proud to announce the opening of its all-new AIT-Chicago office and warehouse, a LEED-certified facility in Palatine, Illinois.
  • In addition to two floors (30,000 square feet) of modern office space, the new location’s bonded warehouse is also a Transportation Security Administration Certified Cargo Screening Facility.
  • According to AIT’s President and Chief Operating Officer, Keith Tholan, the multi-purpose facility was also designed to support the organization’s core values.
  • “This modern facility is a testament to the company’s growth and the hard work of our dedicated teammates,” Tholan said.

Advanced IT Labs Launches AIT LABS PLATFORM - A Revolutionary AI-Driven Platform Set to Transform Small Businesses Orlando, FL

Retrieved on: 
Friday, January 19, 2024

ORLANDO, Fla., Jan. 19, 2024 /PRNewswire-PRWeb/ -- Advanced IT Labs (AIT LABS) is excited to announce the launch of AIT LABS' new Platform. An innovative Artificial Intelligence (AI) platform that will empower small businesses to compete, grow, and scale like never before. This ground-breaking solution is poised to disrupt the industry by providing small businesses with the resources typically only accessible to larger organizations. AIT LABS delivers game-changing technology to small businesses that previously found the costs and risks associated with custom solutions prohibitive.

Key Points: 
  • Advanced IT Labs (AIT LABS) is excited to announce the launch of AIT LABS' new Platform.
  • AIT LABS delivers game-changing technology to small businesses that previously found the costs and risks associated with custom solutions prohibitive.
  • ORLANDO, Fla., Jan. 19, 2024 /PRNewswire-PRWeb/ -- Advanced IT Labs (AIT LABS) is excited to announce the launch of AIT LABS' new Platform.
  • "Our mission with AIT LABS is to democratize access to cutting-edge technology for small businesses," said Paiman Allage, CEO & Carla Allage President of Advanced IT Labs.

Applied Industrial Technologies to Report Second Quarter Earnings and Conduct Conference Call on January 25, 2024

Retrieved on: 
Friday, January 12, 2024

Applied Industrial Technologies (NYSE: AIT) today announced it will release its fiscal 2024 second quarter results on Thursday, January 25, 2024, before the market opens.

Key Points: 
  • Applied Industrial Technologies (NYSE: AIT) today announced it will release its fiscal 2024 second quarter results on Thursday, January 25, 2024, before the market opens.
  • The Company’s fiscal 2024 second quarter ended December 31, 2023.
  • A supplemental presentation detailing latest quarter results will be available on the Investor Relations portion of the Company’s website at www.applied.com .
  • A live audio webcast can be accessed online through the investor relations portion of the Company’s website at www.applied.com .