Steroid

MoonLake announces significant improvements with Nanobody® sonelokimab over 24 weeks in active psoriatic arthritis (PsA) and other important updates at its R&D Day

Retrieved on: 
Sunday, March 10, 2024

In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively.

Key Points: 
  • In addition, by week 24, over 80% and 60% of patients treated with sonelokimab achieved Psoriasis Area Severity Index (PASI) 90 and 100, respectively.
  • Treatment with sonelokimab resulted in unprecedented improvements in composite scores that reflect responses in different domains simultaneously.
  • In all composite scores, sonelokimab showed 16-29 percentage point differences to the reference adalimumab arm, comparatively higher to competitors using the same reference arm.
  • The discontinuation rate of the second part of ARGO remained low at 5%, in line with other sonelokimab trials.

JUVÉDERM® VOLUMA® XC For Temple Hollows Receives U.S. FDA Approval

Retrieved on: 
Tuesday, March 5, 2024

IRVINE, Calif., March 5, 2024 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of JUVÉDERM® VOLUMA® XC for injection in the temple region to improve moderate to severe temple hollowing in adults over the age of 21.1 JUVÉDERM® VOLUMA® XC is the first and only hyaluronic acid (HA) dermal filler to receive U.S. FDA approval for the improvement of moderate to severe temple hollowing with results lasting up to 13 months with optimal treatment.*1

Key Points: 
  • *1
    "The approval of JUVÉDERM® VOLUMA® XC to treat temple hollows further demonstrates Allergan Aesthetics commitment to innovation and addressing patient needs," said Carrie Strom, President, Allergan Aesthetics and Senior Vice President, AbbVie.
  • "This is the first U.S. FDA approval of a hyaluronic acid dermal filler for use in the upper face and addresses a real unmet need for patients."
  • The safety of JUVÉDERM® VOLUMA® XC in patients with a history of excessive scarring or pigmentation disorders has not been studied.
  • To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1‑877‑345‑5372.

Grattan on Friday: Morrison’s departure will help Liberals ‘move on’ but Nationals can’t ‘move on’ until Barnaby does

Retrieved on: 
Thursday, February 15, 2024

For the Liberals, Morrison’s departure is a significant symbolic “moving on” moment.

Key Points: 
  • For the Liberals, Morrison’s departure is a significant symbolic “moving on” moment.
  • The Coalition Morrison is exiting is a mixed bunch, in terms of performance, illustrated by the first weeks of this year.
  • The opposition could not have avoided being outfoxed by Prime Minister Anthony Albanese’s bold reworking of the tax cuts.
  • The Liberals used material from this week’s Senate estimates hearing to pound Immigration Minister Andrew Giles in the House of Representatives.
  • Among the Nationals, their Senate leader, Bridget McKenzie, has proved very effective this term, notably on Qantas and Qatar Airways.
  • Once hailed as a great “retail” politician, Joyce at the 2022 election was considered a retail negative in many Liberal seats.
  • While he is in parliament, the Nationals will remain a tinderbox (even though they manage to hold their seats).


Michelle Grattan does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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.

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

SaNOtize to Evaluate Nitric Oxide Nasal Spray for the Treatment of Sinusitis

Retrieved on: 
Tuesday, February 13, 2024

SaNOtize Research & Development Corp., a therapeutics technology company based in Vancouver, BC, announced today the start of a Phase 2 safety and efficacy trial of its novel Nitric Oxide Nasal Spray (NONS) for the treatment of recurrent acute rhinosinusitis (RARS).

Key Points: 
  • SaNOtize Research & Development Corp., a therapeutics technology company based in Vancouver, BC, announced today the start of a Phase 2 safety and efficacy trial of its novel Nitric Oxide Nasal Spray (NONS) for the treatment of recurrent acute rhinosinusitis (RARS).
  • The trial will focus on treating patients promptly upon the start of a sinusitis episode and will evaluate the impact of NONS treatment in accelerating the time to recovery from the sinusitis episode with symptom resolution.
  • If shown successful, this nasal spray treatment may enable faster resolution of symptoms whenever a patient experiences a sinusitis episode and may reduce the use of antibiotics and steroids in RARS patients.
  • "Our goal in developing the SaNOtize nasal spray is to apply the well-known antimicrobial effects of nitric oxide to treat people with upper respiratory infections.

Telix Signs Agreement to Acquire QSAM Biosciences and Its Bone Cancer Targeting Platform

Retrieved on: 
Wednesday, February 7, 2024

MELBOURNE, Australia, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has entered into an agreement to acquire QSAM Biosciences, Inc. (U.S. OTC: QSAM) and its lead investigational drug Samarium-153-DOTMP (153Sm-DOTMP).

Key Points: 
  • MELBOURNE, Australia, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has entered into an agreement to acquire QSAM Biosciences, Inc. (U.S. OTC: QSAM) and its lead investigational drug Samarium-153-DOTMP (153Sm-DOTMP).
  • QSAM is a United States (U.S.) based company developing therapeutic radiopharmaceuticals for primary and metastatic bone cancer.
  • Telix believes that 153Sm-DOTMP may benefit patients with metastatic lung and breast cancer, where many patients develop brain and bone metastases, and disease management often focusses on quality-of-life palliative care.
  • Telix will issue ordinary shares to the stockholders of QSAM at closing within its Listing Rule 7.1 placement capacity as consideration for the acquisition.

Dietary supplements and protein powders fall under a ‘wild west’ of unregulated products that necessitate caveats and caution

Retrieved on: 
Tuesday, February 6, 2024

The marketing of dietary supplements has been quite effective, with 77% of Americans reporting feeling that the supplement industry is trustworthy.

Key Points: 
  • The marketing of dietary supplements has been quite effective, with 77% of Americans reporting feeling that the supplement industry is trustworthy.
  • A 2024 study found that approximately 1 in 10 adolescents have used nonprescribed weight loss and weight control products, including dietary supplements.
  • The unregulated market of dietary supplements is setting consumers up to be misled and potentially seriously harmed by these products.

The wild west

  • Some of these products are labeled as dietary supplements but are anything but.
  • Products containing kratom, a substance with opioidlike effects, which are sold over the counter in many gas stations, claim to be herbal supplements but are mislabeled.
  • Under a 1994 law, dietary supplements are classified as food, not as drugs.

The FDA is cracking down

  • In August 2021, the FDA cracked down on some of these weight loss products because of the presence of undeclared drugs.
  • While the FDA may take further action beyond the recalls, the agency acknowledged that it is not able to test every weight loss supplement for contamination with drugs.
  • Some weight loss supplements may have FDA warnings on them.

Eating disorders

  • People who have eating disorders often suffer related health issues such as bone loss, osteoporosis and vitamin deficiencies.
  • Diet pill and supplement use has also been associated with increased risk for developing eating disorders and disordered eating, as well as low self-esteem, depression and substance use.
  • While dietary supplements do not solely cause eating disorders or disordered eating, they are one contributing factor that may be addressed with preventive measures and regulations.

The allure of protein powders and fitness supplements

  • Protein powders and other fitness supplements also have wide appeal.
  • But a growing problem in boys is the use of fitness supplements such as protein powder and creatine products, a compound that supplies energy to the muscles.
  • Protein powders make claims of building lean muscles, while creatine boasts providing energy for short-term, intense exercise.

Possible solutions

  • One proposed regulation by researchers at Harvard University includes taxing dietary supplements whose labels tout weight loss benefits.
  • Another policy recommendation involves banning the sale of dietary supplements and other weight loss products to protect minors from these underregulated and potentially dangerous products.


The authors do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.

Re-engineering Immune Cells Opens Door to Promising Therapy for Lupus Kidney Inflammation

Retrieved on: 
Tuesday, February 6, 2024

NEW YORK, Feb. 6, 2024 /PRNewswire/ -- Research featured in Nature Communications highlights a novel approach that re-engineers a person's own immune cells to suppress the overactive immune system that occurs in lupus nephritis, a serious and potentially life-threatening inflammation of the kidneys. With funding in part from the Lupus Research Alliance (LRA), associate professor Joshua Ooi, Ph.D. and his team at the Centre for Inflammatory Disease, Monash Health in Australia, developed an innovative method that could enable multiple targeted therapies not only for lupus but other autoimmune diseases as well.

Key Points: 
  • T cells direct the immune system's response to potential threats by identifying and attacking harmful invaders like viruses and bacteria.
  • In healthy individuals, a specific type of T cells called T regulatory cells (Tregs) prevent the immune system from continuing to react once an infection is cleared.
  • Earlier LRA funding allowed my team to pursue the idea that patients' immune cells could be engineered to correct immune dysfunction.
  • The Lupus Innovation Award then gave us the ability to test the effectiveness of these patient-derived engineered cells in a model of disease."

Sangamo Therapeutics Announces Updated Phase 1/2 STAAR Study Data in Fabry Disease Showing Sustained Benefit and Differentiated Safety Profile

Retrieved on: 
Monday, February 5, 2024

Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced updated preliminary data from the Phase 1/2 STAAR clinical study evaluating isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease.

Key Points: 
  • Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced updated preliminary data from the Phase 1/2 STAAR clinical study evaluating isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease.
  • “Despite the availability of ERT and chaperone therapies, Fabry disease treatment is burdensome, with some patients still developing disease progression.
  • The most common adverse events were pyrexia, headache, COVID-19, fatigue and nasopharyngitis (majority Grade 1/2, with one Grade 3 pyrexia).
  • The data demonstrated supraphysiological plasma and liver α-Gal A activity in mouse models, supporting Phase 1/2 and potential Phase 3 clinical dosing.