Liver

Inaugural Award Poised to Advance Treatment Options for Uveal Melanoma Patients

Retrieved on: 
Friday, February 16, 2024

WASHINGTON , Feb. 16, 2024 /PRNewswire-PRWeb/ -- The Melanoma Research Foundation (MRF) recently announced the winners of the inaugural CURE OM Options Bring Hope Team Science Award: Bruce Ksander, PhD from the Schepens Eye Research Institute; Rizwan Haq MD, PhD from the Dana-Farber Cancer Institute and Margarete Karg, PhD from Massachusetts Eye and Ear Infirmary. The collaborative research project is titled, "Identification of molecular pathways that drive uveal melanoma metastasis." The goal of the team's research is to determine the main factors that drive uveal melanoma (UM) to spread and specifically target the liver, with the hope that this research may guide the development of effective therapeutic interventions. Uveal melanoma is a type of ocular melanoma (OM) and is the most common type of eye cancer in adults that constitutes around 5 of all melanomas. In about half of all UM cases, the disease will spread to other parts of the body. When this occurs, it is almost always fatal.

Key Points: 
  • The collaborative research project is titled, "Identification of molecular pathways that drive uveal melanoma metastasis."
  • Uveal melanoma is a type of ocular melanoma (OM) and is the most common type of eye cancer in adults that constitutes around 5 of all melanomas.
  • The CURE OM Options Bring Hope Team Science Award intends to support an interdisciplinary research team who is researching treatment options for metastatic UM patients not limited by HLA type.
  • To learn more about the CURE OM Options Bring Hope Team Science Award, read here .

Herbal medicinal product: Cimicifugae rhizomaArray, C: ongoing call for scientific data

Retrieved on: 
Friday, February 16, 2024

Overview

Key Points: 
  • Overview
    This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of black cohosh.
  • The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing black cohosh.
  • Black cohosh preparations may also be found in combination with other herbal substances in some herbal medicines.
  • - Therapeutic area
    - Urinary tract and genital disorders
    - Status
    - C: ongoing call for scientific data
    - Date added to the inventory
    - Date added to priority list
    - Outcome of European assessment
    - European Union herbal monograph

Getlabs to Add GRAIL's GalleriⓇ Multi-Cancer Early Detection Test to Suite of At-Home Diagnostic Services

Retrieved on: 
Thursday, February 15, 2024

MIAMI, Feb. 15, 2024 /PRNewswire/ -- Getlabs , the nationwide leader for at-home diagnostics, today announced that it will be adding GRAIL's GalleriⓇ multi-cancer early detection test to its list of test offerings.

Key Points: 
  • MIAMI, Feb. 15, 2024 /PRNewswire/ -- Getlabs , the nationwide leader for at-home diagnostics, today announced that it will be adding GRAIL's GalleriⓇ multi-cancer early detection test to its list of test offerings.
  • The Galleri test is a significant advancement in multi-cancer early detection screening.
  • "By leveraging our expertise in at-home diagnostic collections, we can greatly expand access to critical cancer screening services.
  • Our partnership with GRAIL represents a step forward in saving lives through early cancer detection."

Intellia Therapeutics and ReCode Therapeutics Announce Strategic Collaboration to Develop Novel Gene Editing Therapies for Cystic Fibrosis

Retrieved on: 
Thursday, February 15, 2024

and MENLO PARK, Calif., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, and ReCode Therapeutics, a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, today announced a strategic collaboration to develop novel genomic medicines for the treatment of cystic fibrosis (CF).

Key Points: 
  • and MENLO PARK, Calif., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, and ReCode Therapeutics, a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, today announced a strategic collaboration to develop novel genomic medicines for the treatment of cystic fibrosis (CF).
  • Intellia will be responsible for the design of the editing strategy and research-grade components for the investigational therapies.
  • “This collaboration provides further validation of ReCode's SORT LNP platform to deliver diverse gene editing modalities to specific cells and tissues.
  • By combining our highly synergistic technologies and capabilities, we are excited about the potential to enable a faster path for next-generation gene editing therapeutics to CF patients.”

Intellia Therapeutics and ReCode Therapeutics Announce Strategic Collaboration to Develop Novel Gene Editing Therapies for Cystic Fibrosis

Retrieved on: 
Thursday, February 15, 2024

Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, and ReCode Therapeutics, a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, today announced a strategic collaboration to develop novel genomic medicines for the treatment of cystic fibrosis (CF).

Key Points: 
  • Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, and ReCode Therapeutics, a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, today announced a strategic collaboration to develop novel genomic medicines for the treatment of cystic fibrosis (CF).
  • Intellia will be responsible for the design of the editing strategy and research-grade components for the investigational therapies.
  • “This collaboration provides further validation of ReCode's SORT LNP platform to deliver diverse gene editing modalities to specific cells and tissues.
  • By combining our highly synergistic technologies and capabilities, we are excited about the potential to enable a faster path for next-generation gene editing therapeutics to CF patients.”

Ironwood Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Results; Achieves 2023 Financial Guidance

Retrieved on: 
Thursday, February 15, 2024

Total revenues in the fourth quarter of 2023 were $117.6 million, compared to $107.2 million in the fourth quarter of 2022.

Key Points: 
  • Total revenues in the fourth quarter of 2023 were $117.6 million, compared to $107.2 million in the fourth quarter of 2022.
  • Operating expenses in the fourth quarter of 2023 were $80.0 million, compared to $38.8 million in the fourth quarter of 2022.
  • Adjusted EBITDA was $39.9 million in the fourth quarter of 2023, compared to $68.7 million in the fourth quarter of 2022.
  • Ironwood generated $35.8 million in cash from operations in the fourth quarter of 2023, compared to $79.2 million in cash from operations in the fourth quarter of 2022.

Why banning gym selfies could do us all a lot of good

Retrieved on: 
Wednesday, February 14, 2024

It’s easy to see why taking selfies could be considered inappropriate in such cases.

Key Points: 
  • It’s easy to see why taking selfies could be considered inappropriate in such cases.
  • When considered alongside a rise in toxic influencer culture and widespread body-image insecurity, it could be argued banning gym selfies is a positive step.

Self-obsession in the digital age

  • One of the most famous Greek myths is that of Narcissus, who gave us the word “narcissist”.
  • This is the tale of a young man captivated by his own image.
  • Yet research shows narcissism is not only very prevalent in the modern age, in many cases it’s lucratively rewarded.

Gyms push back against selfies

  • Gym selfies can be tied particularly closely to influencer culture.
  • Influencers posting gym selfies will typically gain a lot of views and likes, and in some cases may attract mass followings.
  • Research shows gym selfies can also influence people’s motivations for exercising.
  • Study participants reported becoming more conscious of their own bodies when they saw gym selfies online.

Self-care in the social media age

  • And social media are a potent driver of the latter.
  • This promotes an obsession with self-image and pushes us to reach social media-worthy levels of muscularity or leanness.
  • Research shows adolescents in particular can have negative mental health outcomes as a result of self-image comparisons on social media.

Exercising for ourselves

  • At the same time, these individuals wield significant power within communities (both online and offline) and have an opportunity to shape norms around fitness and body image.
  • It might just be the beginning of people exercising for themselves and nobody else.


Samuel Cornell receives funding from Meta Platforms, Inc. His research is also supported by a UNSW University Postgraduate Award funded by the Australian Government. Timothy Piatkowski is a Lecturer and Researcher at Griffith University. He is also affiliated with Queensland Injectors Voice for Advocacy and Action.

HistoSonics Awarded Key Position in UK’s Novel Innovation Program

Retrieved on: 
Wednesday, February 14, 2024

The Edison Histotripsy System was measured against four distinct eligibility criteria that were required of applicants for consideration in the IDAP program.

Key Points: 
  • The Edison Histotripsy System was measured against four distinct eligibility criteria that were required of applicants for consideration in the IDAP program.
  • HistoSonics' Edison System uses proprietary technology and advanced imaging to deliver personalized, non-invasive histotripsy treatments with precision and control.
  • Uniquely, the HistoSonics’ platform also provides physicians the ability to monitor the destruction of tissue under continuous real-time visualization and control, unlike any modality that exists today.
  • The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.

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

      Page 11/12

      41.

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

      Page 12/12

Grifols announces positive topline phase 3 fibrinogen clinical trial results

Retrieved on: 
Wednesday, February 14, 2024

AFD, which typically occurs during surgical procedures when there’s insufficient fibrinogen to arrest bleeding, is commonly treated with cryoprecipitate (a plasma extract) or fresh frozen plasma, both containing fibrinogen.

Key Points: 
  • AFD, which typically occurs during surgical procedures when there’s insufficient fibrinogen to arrest bleeding, is commonly treated with cryoprecipitate (a plasma extract) or fresh frozen plasma, both containing fibrinogen.
  • Fibrinogen, a plasma protein produced in the liver, plays a key role in stopping blood loss and in wound healing.
  • “The positive results for Biotest’s fibrinogen are an important milestone and strengthen a Grifols innovation strategy that’s diversified across plasma and non-plasma, balanced between internal and external investments, and includes both shorter- and longer-term development cycles,” said Victor Grifols Deu, Grifols Chief Operating Officer.
  • The acquisition of Biotest has significantly reinforced Grifols’ access to plasma, as well as the company’s pipeline and sales presence.