Betahistine

Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)

Retrieved on: 
Wednesday, February 14, 2024

Industry level .................................................................................................. 13

Key Points: 
    • Industry level .................................................................................................. 13

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      1.

    • A reflection paper
      (RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      plan, and it is envisaged that something similar may be needed for other emerging treatment
      modalities (e.g., peptides).

    • Guideline work led by other working parties
      ?

      Revision of the guideline on the requirements for clinical documentation for orally inhaled
      products (CPMP/EWP/4151/00 Rev.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      The planned concept papers (CPs) will formulate problem statements for potential workshops and
      subsequent guidance documents will be informed and enriched by the outcome of discussions of
      workshops to be held in 2024.

    • Guideline work led by other working parties and committees
      ?

      Revision of Guidance on the investigation of medicinal products in the term and preterm
      neonate (EMEA/536810/2008).

    • There is a need for
      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      new guidance in these areas to ensure these novel approaches meet the required evidentiary
      standards and facilitate their evaluation.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      Provide appropriate support to the EU network for generic and hybrid medicines including
      product-specific requirements.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      2.3.

    • ?

      Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
      based biopharmaceutics modelling (PBBM).

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      In order to support adequate evaluation of all methodology MWP will aim to facilitate an
      increase in presence and visibility in relevant committees of methodological expertise from
      across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
      2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
      depot) and melatonin have been prioritised as the next in series for drafting.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      4.2.

    • ?

      Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
      assessment.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      To deliver an improved access to raw data (e.g.

    • ?

      Propose regulatory research priorities for funders in across the activities of Methodology
      Working Party, including in the big data area.

    • ?

      Establish key communication points in national competent authorities and build a resource of
      key messages and communication materials on regulation and methodology.

    • The timing of workshops may need to be arranged according to the

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      specific needs of the guidance ? either before the guidance is finalised to gather views and
      expertise; or once it is finalised for training purposes.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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Altamira Therapeutics Announces European Patent Office Decision to Grant for Patent Application Covering Intranasal Betahistine

Retrieved on: 
Friday, November 10, 2023

November 10, 2023 -- Altamira Therapeutics Ltd. ("Altamira" or the "Company") (Nasdaq:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that it has received an “Intention to Grant” notice from the European Patent Office (EPO) for its patent application titled “Intranasal Composition Comprising Betahistine” (designated as European Patent 3698791).

Key Points: 
  • November 10, 2023 -- Altamira Therapeutics Ltd. ("Altamira" or the "Company") (Nasdaq:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that it has received an “Intention to Grant” notice from the European Patent Office (EPO) for its patent application titled “Intranasal Composition Comprising Betahistine” (designated as European Patent 3698791).
  • The application is a continuation of the previously granted European Patent 3474850 and upon issuance, is expected to remain valid until February 2038.
  • Combined, these two patents will provide key intellectual property protection for the Company's intranasal betahistine program (AM-125) in Europe.
  • “We are very pleased with the continued expansion of our patent portfolio covering the intranasal betahistine program,” commented Thomas Meyer, Altamira Therapeutics’ founder, Chairman and CEO.

Altamira Therapeutics Provides Business Update and First Half 2022 Financial Results

Retrieved on: 
Wednesday, November 30, 2022

We continue to make good progress with the transformation of Altamira into an RNA delivery technology company, stated Thomas Meyer, Altamira Therapeutics founder, Chairman and CEO.

Key Points: 
  • We continue to make good progress with the transformation of Altamira into an RNA delivery technology company, stated Thomas Meyer, Altamira Therapeutics founder, Chairman and CEO.
  • Total operating expenses for the first half of 2022 were CHF 7.5 million compared with CHF 6.5 million for the first half of 2021.
  • R&D expenses for the first half of 2022 were CHF 3.6 million compared with CHF 3.4 million for the first half of 2021.
  • Altamira expects its total cash need for funding operations in 2022 to be in the range of CHF 12.0 to 13.0 million.

Auris Medical Provides Update on Intranasal Betahistine Development Program

Retrieved on: 
Friday, April 3, 2020

The Phase 1b trial with AM-201, intranasal betahistine for the prevention of antipsychotic-induced weight gain and somnolence, has remained unaffected by the COVID-19 pandemic.

Key Points: 
  • The Phase 1b trial with AM-201, intranasal betahistine for the prevention of antipsychotic-induced weight gain and somnolence, has remained unaffected by the COVID-19 pandemic.
  • The Phase 2 trial with AM-125, intranasal betahistine for the treatment of acute peripheral vertigo, will be impacted by the COVID-19 outbreak.
  • Auris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology and CNS disorders.
  • All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Auris Medical or to persons acting on behalf of Auris Medical are expressly qualified in their entirety by reference to these risks and uncertainties.

Auris Medical Provides Update on Ongoing Clinical Trials with Intranasal Betahistine

Retrieved on: 
Thursday, March 5, 2020

In addition to the ongoing intranasal dose escalation, open label testing of oral betahistine for reference purposes has commenced.

Key Points: 
  • In addition to the ongoing intranasal dose escalation, open label testing of oral betahistine for reference purposes has commenced.
  • We look forward to sharing the results from our two intranasal betahistine trials during the second quarter of 2020, commented Thomas Meyer, Auris Medicals founder, Chairman and CEO.
  • Auris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology and CNS disorders.
  • All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Auris Medical or to persons acting on behalf of Auris Medical are expressly qualified in their entirety by reference to these risks and uncertainties.

Auris Medical Announces Notices of Allowance for U.S. and European Patent Applications Covering Intranasal Betahistine

Retrieved on: 
Wednesday, September 11, 2019

In addition, the Company received an Intention to Grant notice from the European Patent Office (EPO) for its related patent application entitled Intranasal Composition Comprising Betahistine (European Patent Application 18 703 749.4).

Key Points: 
  • In addition, the Company received an Intention to Grant notice from the European Patent Office (EPO) for its related patent application entitled Intranasal Composition Comprising Betahistine (European Patent Application 18 703 749.4).
  • The allowed claims cover composition of matter and methods of use for formulations of betahistine dihydrochloride for intranasal delivery.
  • Auris Medical also has filed corresponding patent applications that will allow the Company to seek similar patent protection in other key markets throughout the world.
  • Auris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders.