Toxicity

Ginkgo Bioworks and SaponiQx Awarded MCDC Contract to Discover and Manufacture Next-Generation Vaccine Adjuvants Using Generative Molecular Design

Retrieved on: 
Thursday, February 15, 2024

Adjuvants are components of vaccines that help to enhance the magnitude, breadth, and duration of the immune response to vaccination.

Key Points: 
  • Adjuvants are components of vaccines that help to enhance the magnitude, breadth, and duration of the immune response to vaccination.
  • Currently, only a handful of adjuvants are available for human use in licensed vaccines.
  • Ginkgo will develop a first-generation Adjuvant Development Candidate (ADC) production method, using a heterologous production strain such as brewers' yeast, Saccharomyces cerevisiae.
  • Development of a first-generation ADC production method could facilitate further development of a sustainable mass-production manufacturing process for these complex adjuvants.

Lithium-Ion Capacitors and Battery Supercapacitor Hybrids Set to Drive $10 Billion Market Growth: Opportunities for Investors and Industry Players

Retrieved on: 
Thursday, February 15, 2024

The latest research report on lithium-ion capacitors (LIC) and other battery supercapacitor hybrid (BSH) storage systems reveals significant market advancements and forecasts a burgeoning industry, estimated to reach a $10 billion valuation by 2044.

Key Points: 
  • The latest research report on lithium-ion capacitors (LIC) and other battery supercapacitor hybrid (BSH) storage systems reveals significant market advancements and forecasts a burgeoning industry, estimated to reach a $10 billion valuation by 2044.
  • The report provides valuable insights for stakeholders in the energy storage sector, including investors, manufacturers, and system integrators.
  • This detailed analysis covers a range of emerging technologies, including LIC and BSHs, that are poised to transform multiple sectors.
  • Industry professionals will find the Executive Summary and Conclusions section particularly insightful, offering a succinct yet thorough overview of the report's findings.

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

      Page 2/14

      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

      Page 3/14

      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

      Page 4/14

      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

      Page 5/14

      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

      Page 6/14

      ?

      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

      Page 7/14

      ?

      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

      Page 8/14

      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

      Page 10/14

      ?

      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

      Page 12/14

      ?

      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

      Page 13/14

      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

      Page 14/14

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
Wednesday, February 14, 2024

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 5/12

      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 6/12

      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

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      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 12/12

AIM ImmunoTech Announces First Subject Dosed in the Netherlands for Phase 1b/2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi (durvalumab) for the Treatment of Pancreatic Cancer

Retrieved on: 
Wednesday, February 14, 2024

The primary objective of the Phase 2 portion is to determine the clinical benefit rate of the combination therapy.

Key Points: 
  • The primary objective of the Phase 2 portion is to determine the clinical benefit rate of the combination therapy.
  • Subjects will start with Ampligen 200 mg via IV infusion twice per week for a total of 6 weeks (12 doses).
  • The first dose of Ampligen will be administered preferably 4-6 weeks after the last chemotherapy FOLFIRINOX dose.
  • After two doses of Ampligen, the first dose of durvalumab 1500 mg via IV infusion will be introduced in week 2.

IN8bio Announces Publication on Novel Gamma-Delta T Cell Therapy for Glioblastoma in Frontiers in Immunology

Retrieved on: 
Wednesday, February 14, 2024

(NASDAQ: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced a publication in Frontiers in Immunology that reviews IN8bio’s novel approach for solid tumors, such as glioblastoma (GBM), an aggressive form of brain cancer.

Key Points: 
  • (NASDAQ: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced a publication in Frontiers in Immunology that reviews IN8bio’s novel approach for solid tumors, such as glioblastoma (GBM), an aggressive form of brain cancer.
  • Cellular therapies, particularly chimeric antigen receptor T cell therapies (CAR-T), have shown promise in hematologic malignancies but have faced significant challenges when applied to solid tumors like GBM.
  • The INB-200 and INB-400 studies by IN8bio addresses the challenges towards targeting solid tumors by harnessing the innate immune functions of gamma-delta T cells.
  • IN8bio is also conducting a Phase 2 clinical trial of a genetically modified autologous gamma-delta T cell therapy (INB-400) targeting newly diagnosed GBM.

GSK Exercises Option to License Elsie Biotechnologies’ Discovery Platform to Find and Develop Novel Oligonucleotides

Retrieved on: 
Wednesday, February 14, 2024

Elsie Biotechnologies, Inc. announced today that GSK plc (LSE/NYSE: GSK) has exercised its option to a non-exclusive license to Elsie’s discovery platform, following a successful outcome of the research collaboration , announced in July 2023, to explore the platform capabilities.

Key Points: 
  • Elsie Biotechnologies, Inc. announced today that GSK plc (LSE/NYSE: GSK) has exercised its option to a non-exclusive license to Elsie’s discovery platform, following a successful outcome of the research collaboration , announced in July 2023, to explore the platform capabilities.
  • The option allows GSK to employ Elsie’s discovery platform and P(V) chemistry technologies in its own oligonucleotide drug discovery research.
  • Kevin Green, Chief Operating Officer, Elsie Biotechnologies, said, "We are pleased that GSK has elected to license our platform technology following the research collaboration.
  • Under the terms of the agreement, Elsie will receive a license payment from GSK and could receive additional development and commercial milestones on a target-by-target basis.

CitiusTech Launches Healthcare’s First End-to-End Generative AI Quality & Trust Solution

Retrieved on: 
Wednesday, February 14, 2024

CitiusTech , a leading provider of healthcare technology services and solutions, announced that it has launched an industry-first solution for healthcare organizations to help address the reliability, quality and trust requirements for Generative AI (Gen AI) solutions.

Key Points: 
  • CitiusTech , a leading provider of healthcare technology services and solutions, announced that it has launched an industry-first solution for healthcare organizations to help address the reliability, quality and trust requirements for Generative AI (Gen AI) solutions.
  • The CitiusTech Gen AI Quality & Trust solution will help organizations design, develop, integrate, and monitor quality and facilitate trust in Generative AI applications, providing the confidence needed to adopt and scale Gen AI applications enterprise-wide.
  • But we find that over 80% of Gen AI proofs of concept and initiatives are delayed due to reliability and compliance concerns, due to lack of trust in Gen AI solutions.
  • “Our Gen AI Quality & Trust Solution is the first systematic approach in healthcare to quantitatively measure, verify and monitor Gen AI solutions.

Europe Cell-Based Assay Market Analysis and Forecast Report 2023-2032 Featuring Merck KGaA and Lonza Group with Focus on Emerging Technologies and Applications - ResearchAndMarkets.com

Retrieved on: 
Tuesday, February 13, 2024

The "Europe Cell-Based Assay Market: Analysis and Forecast, 2023-2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Europe Cell-Based Assay Market: Analysis and Forecast, 2023-2032" report has been added to ResearchAndMarkets.com's offering.
  • This trend is further amplified by rising chronic disease prevalence and supportive government initiatives, fostering a market poised for significant expansion.
  • The European cell-based assay market is experiencing a surge, fueled by a confluence of factors.
  • The Europe cell-based assay market is anticipated to witness growth during the forecast year 2023-2032.

Find your purr-fect match and explore more pup-ular breeds with enhanced Pet HealthZone®

Retrieved on: 
Tuesday, February 13, 2024

COLUMBUS, Ohio, Feb. 13, 2024 /PRNewswire/ -- Nationwide, the largest U.S. provider of pet health insurance, is sharing a new way for pet parents to feel the love for their canine companions and feline friends this Valentine's Day – by visiting the Pet HealthZone. The Pet HealthZone is an online destination that can help families nurture the needs of their four-legged family members like never before, and even help them find the new love of their life. 

Key Points: 
  • The recently expanded Pet HealthZone now contains detailed profiles of 11 cat breeds and more than 100 dog breeds, including mixed breeds and popular crossbreeds like Labradoodles and Puggles.
  • Altogether, they represent 97% of the dog breeds and 90% of the cat breeds Nationwide currently insures.
  • The Pet HealthZone is designed to help pet parents uncover the increased health risks their pet may face, along with lots of fun information about how to love and care for them right.
  • Looking for love: For families looking to open their hearts and homes to a new pet, the Pet HealthZone can help find a match made in heaven.