Adverse drug reaction

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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Ferring Announces Abstract of the First Prospective, Multi-National, Real-world Study of Rekovelle® (follitropin delta) at the Congress of the Pacific Society for Reproductive Medicine

Retrieved on: 
Monday, March 13, 2023

Today, an oral poster of the first post-authorisation Phase 4 real-world study, PROFILE, is being presented at the 13th Congress of the Pacific Society for Reproductive Medicine (PSRM) 2023 in Australia.

Key Points: 
  • Today, an oral poster of the first post-authorisation Phase 4 real-world study, PROFILE, is being presented at the 13th Congress of the Pacific Society for Reproductive Medicine (PSRM) 2023 in Australia.
  • Results highlighted that with Rekovelle, almost three-quarters (74.0%) of women had between 4-19 oocytes retrieved and 255 women (27.0%) achieved an ongoing pregnancy at 10-11 weeks after transfer.
  • Adverse drug reactions (ADRs) were monitored for all initiated OS cycles, and the number of ADRs leading to treatment and study discontinuation was low (n=4).
  • “Ferring is committed to building healthy families of every shape and size by developing innovative fertility treatments.

Pharmacovigilance Global Market Report 2022: Rising Cases of Adverse Drug Reactions Fueling Growth - ResearchAndMarkets.com

Retrieved on: 
Thursday, November 10, 2022

The "Pharmacovigilance Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2022 to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Pharmacovigilance Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2022 to 2030" report has been added to ResearchAndMarkets.com's offering.
  • The pharmacovigilance market is anticipated to grow at a compound annual growth rate of 13.5% for the forecasted period (2022-2030).
  • As the world's population ages, chronic diseases have increased; and more adverse drug reactions mean more pharmacovigilance.
  • The surge in cases of adverse drug reactions (ADR), the increasing occurrence of chronic diseases (Diabetes, Cancer, etc.)

Global Pharmacovigilance Market Report 2022: Increased Prevalence of ADRs Driving Sector Growth - ResearchAndMarkets.com

Retrieved on: 
Friday, September 9, 2022

The "Global Pharmacovigilance Market - Forecasts from 2022 to 2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Pharmacovigilance Market - Forecasts from 2022 to 2027" report has been added to ResearchAndMarkets.com's offering.
  • The global pharmacovigilance market is expected to grow at a compound annual growth rate of 10.49% over the forecast period to reach a market size of US$9.535 billion in 2027 from US$4.743 billion in 2020.
  • The major driving factors of this market include rising drug consumption and drug development rates, rising rates of adverse drug reactions and drug toxicity, and an increasing tendency to outsource pharmacovigilance services.
  • Therefore, the rising global prevalence of ADRs will increase demand in the pharmacovigilance market.

GeneIQ Leads Education and Implementation of Pharmacogenomics

Retrieved on: 
Tuesday, July 12, 2022

DALLAS, July 12, 2022 /PRNewswire/ -- GeneIQ, a molecular diagnostics (MDx) company based in Dallas, Texas, leads the discussion on the importance of Pharmacogenomics (PGx) and its impact on the healthcare system.

Key Points: 
  • DALLAS, July 12, 2022 /PRNewswire/ -- GeneIQ , a molecular diagnostics (MDx) company based in Dallas, Texas, leads the discussion on the importance of Pharmacogenomics (PGx) and its impact on the healthcare system.
  • In addition, genomic data help clinicians avoid using a trial-and-error approach to prescribing medications, making medication management more efficient and effective.
  • GeneIQ is the only molecular diagnostics laboratory that provides healthcare professionals with real-time decision-making tools for PGx.
  • GeneIQ is a leading molecular diagnostics company specializing in Pharmacogenomic (PGx) testing and RT-PCR testing for infectious diseases, including COVID-19.

Nalagenetics obtains CE Mark for its pharmacogenomics software, Nala Clinical Decision Support™ Module- PGx Core

Retrieved on: 
Tuesday, May 31, 2022

SINGAPORE, May 31, 2022 /PRNewswire/ --Nalagenetics has just completed CE-marking for one of the reporting modules of its Clinical Decision Support (CDS) software.

Key Points: 
  • SINGAPORE, May 31, 2022 /PRNewswire/ --Nalagenetics has just completed CE-marking for one of the reporting modules of its Clinical Decision Support (CDS) software.
  • Nala Clinical Decision Support Module - PGx Core is a companion software to its qPCR kit, Nala PGx Core(R) , which genotypes top pharmacogenes to help providers run pre-emptive pharmacogenomics programs in a cost-effective manner.
  • Nala CDS Module-PGx Core and PGx Core qPCR kit are used together as a plug-and-play solution for labs with qPCR machines.
  • Its flagship product, Nala Clinical Decision Support, is a genetic analysis and interpretation software for flexible input and diverse use cases, starting with pharmacogenomics.

Kala Announces Entry into Definitive Agreement to Sell EYSUVIS® and INVELTYS® to Alcon Inc.

Retrieved on: 
Monday, May 23, 2022

ARLINGTON, Mass., May 23, 2022 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that it has entered into a definitive agreement to sell its commercial portfolio and related intellectual property assets to Alcon Inc. This includes EYSUVIS, the first and only U.S. Food and Drug Administration (FDA) approved medicine for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease, and INVELTYS, a twice-a-day corticosteroid for the treatment of post-operative inflammation and pain following ocular surgery.

Key Points: 
  • Kala plans to focus on developing KPI-012, a novel cell-free secretome therapy that has the potential to address a number of rare and severe ocular diseases.
  • Under the terms of the asset purchase agreement, Kala will receive an upfront payment of $60 million and will be eligible to receive commercial-based sales milestone payments.
  • Piper Sandler acted as the exclusive financial advisor, and Wilmer Cutler Pickering Hale and Dorr LLP served as legal counsel to Kala.
  • Kala believes INVELTYS has a favorable profile for the treatment of inflammation and pain following ocular surgery, due to its twice-a-day dosing regimen.

Kala Pharmaceuticals Announces New Commercial and Medicare Coverage for EYSUVIS®

Retrieved on: 
Tuesday, May 3, 2022

ARLINGTON, Mass., May 03, 2022 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc., (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that the largest Pharmacy Benefit Manager in the United States has added EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% as a covered brand on its commercial formularies, effective May 1, 2022. This adds 28.5 million commercial lives to EYSUVIS coverage, bringing total commercial coverage to 155.3 million lives, or 92% of total commercial lives.

Key Points: 
  • This adds 28.5 million commercial lives to EYSUVIS coverage, bringing total commercial coverage to 155.3 million lives, or 92% of total commercial lives.
  • This adds approximately 7 million Medicare lives to EYSUVIS coverage, bringing total EYSUVIS Medicare coverage to 14.1 million lives, or approximately 30% of all Medicare lives.
  • We are excited to announce this additional payer coverage, which brings our commercial access to 92% of covered lives and doubles our Medicare Part D coverage.
  • Earlier this year, we secured coverage with several large commercial and Medicare Part D plans and, together with these additions, we have now achieved total EYSUVIS coverage for more than 169 million lives.

Kala Pharmaceuticals Announces EYSUVIS® Now Covered on UnitedHealthcare Commercial and Cigna Medicare

Retrieved on: 
Tuesday, March 8, 2022

ARLINGTON, Mass., March 08, 2022 (GLOBE NEWSWIRE) -- Kala Pharmaceuticals, Inc., (NASDAQ:KALA), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that UnitedHealthcare, one of the largest commercial health care plans in the United States, covering approximately 13 million lives, has added EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% as a covered brand on its commercial formularies effective March 2022. EYSUVIS now has coverage for approximately 118 million lives, or 70% of all commercial lives.

Key Points: 
  • EYSUVIS now has coverage for approximately 118 million lives, or 70% of all commercial lives.
  • Also today, Kala announced that Cigna Medicare has added EYSUVIS as a preferred brand effective February 2022, adding an additional 1.9 million Medicare lives.
  • EYSUVIS now has Medicare preferred coverage for select plans with Express Scripts, Prime Therapeutics and Cigna.
  • Total EYSUVIS Medicare coverage is now approximately 7.1 million lives, or 15% of all Medicare lives.

Worldwide Pharmacovigilance Outsourcing Industry to 2030 - Featuring Accenture, Ergomed and Genpact Among Others - ResearchAndMarkets.com

Retrieved on: 
Friday, January 21, 2022

The global pharmacovigilance outsourcing market was valued at $2,489.10 million in 2020, and is projected to reach $9,654.10 million by 2030 registering a CAGR of 14.60% from 2021 to 2030.

Key Points: 
  • The global pharmacovigilance outsourcing market was valued at $2,489.10 million in 2020, and is projected to reach $9,654.10 million by 2030 registering a CAGR of 14.60% from 2021 to 2030.
  • Pharmacovigilance outsourcing is transfer of drug safety operations and processes to a third-party service provider by a life science firm.
  • Furthermore, management pharmacovigilance outsourcing activities comprise preparing standard operating procedures as well as other controlled quality documents.
  • Extensive analysis of the key segments of the industry helps to understand the application and services of pharmacovigilance outsourcing used across the globe.