Breast

Emulait and Jet-Set-Go Join Forces to Revolutionize Baby Retail Landscape

Retrieved on: 
Tuesday, February 20, 2024

Launched in 2023, Emulait introduces a first-of-its-kind biomimetic baby bottle, designed to replicate the mother's breast in form, feel, and function.

Key Points: 
  • Launched in 2023, Emulait introduces a first-of-its-kind biomimetic baby bottle, designed to replicate the mother's breast in form, feel, and function.
  • "We are excited to join forces with Jet-Set-Go and bring the benefits of innovation to families", said Shilo Ben Zeev, founder, and CEO of Emulait.
  • Shilo and his team have built a brand that is at the forefront of parenting innovation," said Glen Gold, Co-founder/CEO of Jet-Set-Go, the North American Premium Retail Distributor for Emulait.
  • With Emulait's groundbreaking technology and Jet-Set-Go's extensive distribution network, families can expect unparalleled convenience and quality in their baby care products in premium retail stores throughout North America.

BEABA Brings Spain's #1 Bottle & Pacifier Brand Suavinex To The U.S.

Retrieved on: 
Tuesday, February 20, 2024

NEW YORK, Feb. 20, 2024 /PRNewswire/ -- BEABA has introduced Suavinex, Spain's leading bottle and pacifier brand, to the United States, bringing with it the innovative Zerø.Zerø™ Collection. Designed to minimize bottle rejection and nipple confusion, Zerø.Zerø™ is set to redefine the bottle-feeding experience in the U.S.

Key Points: 
  • NEW YORK, Feb. 20, 2024 /PRNewswire/ -- BEABA has introduced Suavinex, Spain's leading bottle and pacifier brand, to the United States, bringing with it the innovative Zerø.Zerø™ Collection.
  • The Zerø.Zerø™ collection is a seamless system, offering a smooth transition between breast, bottle and pacifier.
  • Suavinex's Zerø.Zerø™ Pacifier: Made of 100% medical grade silicone, the pacifier incorporates the SX Pro™ Nipple and respects oral and dental development.
  • "We are thrilled to bring Suavinex and its Zerø.Zerø™ Collection to the U.S." said John Marshall, Managing Director of BEABA North America.

Tennessee Oncology Launches Rural Telehealth Program to Bridge Digital Divide for Middle Tennessee Cancer Patients

Retrieved on: 
Tuesday, February 20, 2024

To kick off the program, Tennessee Oncology is recruiting Middle Tennessee cancer patients, caregivers, survivors, and patient advocates to participate in the program's design as part of Community Advisory Boards (CABs).

Key Points: 
  • To kick off the program, Tennessee Oncology is recruiting Middle Tennessee cancer patients, caregivers, survivors, and patient advocates to participate in the program's design as part of Community Advisory Boards (CABs).
  • During the Covid-19 pandemic when Tennessee Oncology rapidly deployed telehealth services, patient participation in palliative care, psychology, and integrative oncology grew.
  • In 2022, only 1.5 percent of breast cancer patients and 2.7 percent of prostate cancer patients accessed palliative care in rural and underserved Tennessee counties.
  • "NEST was born from what we learned using telehealth to connect our patients with cancer care services during the pandemic," said Natalie Dickson, MD, President and Chief Strategy Officer, Tennessee Oncology.

Herbal medicinal product: Agni casti fructusArray, C: ongoing call for scientific data

Retrieved on: 
Friday, February 16, 2024

Herbal medicinal product: Agni casti fructusArray, C: ongoing call for scientific data

Key Points: 


Herbal medicinal product: Agni casti fructusArray, C: ongoing call for scientific data

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."

Merit Medical Receives FDA 510(k) Clearance for SCOUT® MD™ Surgical Guidance System

Retrieved on: 
Thursday, February 15, 2024

SOUTH JORDAN, Utah, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, has received US Food and Drug Administration (FDA) 501(k) clearance for the SCOUT® MD™ Surgical Guidance System.

Key Points: 
  • SOUTH JORDAN, Utah, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, has received US Food and Drug Administration (FDA) 501(k) clearance for the SCOUT® MD™ Surgical Guidance System.
  • The release of the new guidance system demonstrates Merit’s ongoing leadership in oncology and marks a significant advancement in breast cancer care.
  • SCOUT MD broadens Merit’s oncology portfolio, designed to enhance diagnosis and treatment of breast and other soft tissue cancers.
  • Products include the SCOUT Radar Localization System with SCOUT Mini Reflector and SCOUT Bx™ Delivery System as well as the SAVI® Brachy System.

CollPlant Issues Letter to Shareholders

Retrieved on: 
Thursday, February 15, 2024

Our long-term collaboration with AbbVie to develop a paradigm-shifting regenerative dermal and soft tissue filler continues to advance.

Key Points: 
  • Our long-term collaboration with AbbVie to develop a paradigm-shifting regenerative dermal and soft tissue filler continues to advance.
  • In June of last year, we announced the achievement of an important milestone under this collaboration which triggered a $10 million payment from AbbVie to CollPlant.
  • Per CollPlant's agreement with AbbVie, CollPlant has the potential to receive additional milestones and option products payments, as well as receive meaningful royalties on product sales.
  • In the second quarter of 2023, CollPlant hired a dedicated expert to lead our Environment, Social and Governance (ESG) effort.

Lantern Pharma Advances Unique ADC (Antibody Drug Conjugate) Program Across Multiple Solid Tumor Cancers

Retrieved on: 
Thursday, February 15, 2024

Lantern Pharma Inc. (NASDAQ: LTRN), a leader in AI-driven cancer drug discovery and development, announced an important milestone in its antibody-drug conjugate (ADC) program.

Key Points: 
  • Lantern Pharma Inc. (NASDAQ: LTRN), a leader in AI-driven cancer drug discovery and development, announced an important milestone in its antibody-drug conjugate (ADC) program.
  • In collaboration with Bielefeld University, Lantern has generated a new class of highly specific and highly potent ADCs with a cryptophycin drug-payload.
  • View the full release here: https://www.businesswire.com/news/home/20240215526567/en/
    Preclinical results from Lantern's cryptophycin ADC (Cp-ADC) in HER2 expressing cancers in comparison with commercially available MMAE payload antibody-drug conjugates (ADCs).
  • These efforts aim to improve ADC development for specific patient populations and potentially guide more effective future clinical treatments with less cost and greater efficiency than historical ADC drug development.

Feminist narratives are being hijacked to market medical tests not backed by evidence

Retrieved on: 
Thursday, February 15, 2024

In the 1980s, companies co-opted messaging about female autonomy to encourage women’s consumption of unhealthy commodities, such as tobacco and alcohol.

Key Points: 
  • In the 1980s, companies co-opted messaging about female autonomy to encourage women’s consumption of unhealthy commodities, such as tobacco and alcohol.
  • Today, feminist narratives around empowerment and women’s rights are being co-opted to market interventions that are not backed by evidence across many areas of women’s health.
  • Some of these health technologies, tests and treatments are useful in certain situations and can be very beneficial to some women.

The AMH test

  • The AMH test is a blood test associated with the number of eggs in a woman’s ovaries and is sometimes referred to as the “egg timer” test.
  • Although often used in fertility treatment, the AMH test cannot reliably predict the likelihood of pregnancy, timing to pregnancy or specific age of menopause.
  • Despite this, several fertility clinics and online companies market the AMH test to women not even trying to get pregnant.
  • Some use feminist rhetoric promising empowerment, selling the test as a way to gain personalised insights into your fertility.
  • 'Egg timer' tests can't reliably predict your chance of conceiving or menopause timing

    Our recent study found around 30% of women having an AMH test in Australia may be having it for these reasons.

Breast density notification


Breast density is one of several independent risk factors for breast cancer. It’s also harder to see cancer on a mammogram image of breasts with high amounts of dense tissue than breasts with a greater proportion of fatty tissue. While estimates vary, approximately 25–50% of women in the breast screening population have dense breasts.

  • Stemming from valid concerns about the increased risk of cancer, advocacy efforts have used feminist language around women’s right to know such as “women need to know the truth” and “women can handle the truth” to argue for widespread breast density notification.
  • Yet, there is no or little mention of the lack of robust evidence showing that it prevents breast cancer deaths.
  • While stronger patient autonomy is vital, campaigning for breast density notification without stating the limitations or unclear evidence of benefit may go against the empowerment being sought.

Ensuring feminism isn’t hijacked

  • But we need to ensure the goals of feminist health advocacy aren’t undermined through commercially driven use of feminist language pushing care that isn’t based on evidence.
  • Health professionals and governments must also ensure that easily understood, balanced information based on high quality scientific evidence is available.


Brooke Nickel receives fellowship funding from the National Health and Medical Research Council (NHMRC). She is on the Scientific Committee of the Preventing Overdiagnosis Conference. Tessa Copp receives fellowship funding from the National Health and Medical Research Council (NHMRC). She is also on the Scientific Committee of the Preventing Overdiagnosis Conference.

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