Itch

What are ‘collarium’ sunbeds? Here’s why you should stay away

Retrieved on: 
Wednesday, February 14, 2024

A collarium sunbed emits both UV radiation and a mix of visible wavelength colours to produce a pink or red light.

Key Points: 
  • A collarium sunbed emits both UV radiation and a mix of visible wavelength colours to produce a pink or red light.
  • Like an old-school sunbed, the user lies in it for ten to 20 minute sessions to quickly develop a tan.

Why were sunbeds banned?

  • Commercial sunbeds have been illegal across Australia since 2016 (except for in the Northern Territory) under state-based radiation safety laws.
  • Their dangers were highlighted by young Australians including Clare Oliver who developed melanoma after using sunbeds.
  • Research shows people who have used sunbeds at least once have a 41% increased risk of developing melanoma, while ten or more sunbed sessions led to a 100% increased risk.

How are collarium sunbeds supposed to be different?

  • Australian sellers of collarium sunbeds imply they are safe, but their machine descriptions note the use of UV radiation, particularly UVA.
  • UVA is one part of the spectrum of UV radiation.
  • Evidence shows all types of sunbeds increase the risk of melanoma, including those that use only UVA.

Collagen claims

  • One particularly odd claim about collarium sunbeds is that they stimulate collagen.
  • Collagen is the main supportive tissue in our skin.
  • The reactive oxygen species generated by UVA light damage existing collagen structures and kick off a molecular chain of events that downgrades collagen-producing enzymes and increases collagen-destroying enzymes.
  • Over time, a build-up of degraded collagen fragments in the skin promotes even more destruction.

What about phototherapy?

  • The anti-collagen effects of UVA can also be used to treat thickened scars and keloids.
  • Side-effects of UV phototherapy include tanning, itchiness, dryness, cold sore virus reactivation and, notably, premature skin ageing.

So what happens now?

  • It looks like many collariums are just sunbeds rebranded with red light.
  • Queensland Health is currently investigating whether these salons are breaching the state’s Radiation Safety Act, and operators could face large fines.


Katie Lee receives funding from the National Health and Medical Research Council. Anne Cust receives funding from the National Health and Medical Research Council and Medical Research Future Fund.

Dermavant Submits Supplemental New Drug Application (sNDA) to FDA for VTAMA® (tapinarof) Cream, 1% for the Treatment of Atopic Dermatitis in Adults and Children 2 Years of Age and Older

Retrieved on: 
Wednesday, February 14, 2024

VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of AD.

Key Points: 
  • VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of AD.
  • VTAMA cream, 1% data indicated no new safety or tolerability signals of concern in this population including children 2 years of age and older.
  • On May 24, 2022, Dermavant announced the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults.
  • Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults.

Galderma Announces Regulatory Filing Acceptance for Nemolizumab in Prurigo Nodularis and Atopic Dermatitis in the U.S. and EU

Retrieved on: 
Wednesday, February 14, 2024

This follows its designation as a Breakthrough Therapy for the treatment of pruritus associated with prurigo nodularis, originally granted in December 2019 and reconfirmed in March 2023.

Key Points: 
  • This follows its designation as a Breakthrough Therapy for the treatment of pruritus associated with prurigo nodularis, originally granted in December 2019 and reconfirmed in March 2023.
  • Priority Review is granted for medicines that would significantly improve the treatment, diagnosis or prevention of serious conditions.
  • The European Medicines Agency has also accepted Galderma’s Marketing Authorization Applications for nemolizumab in both prurigo nodularis and atopic dermatitis.
  • “The relentless itch experienced by many people living with prurigo nodularis and atopic dermatitis has a significant impact on their overall quality of life.

Gilead Sciences Expands Liver Portfolio With Acquisition of CymaBay Therapeutics

Retrieved on: 
Monday, February 12, 2024

Gilead Sciences, Inc. (Nasdaq: GILD) and CymaBay Therapeutics, Inc. (Nasdaq: CBAY) announced today a definitive agreement under which Gilead will acquire CymaBay for $32.50 per share in cash or a total equity value of $4.3 billion.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) and CymaBay Therapeutics, Inc. (Nasdaq: CBAY) announced today a definitive agreement under which Gilead will acquire CymaBay for $32.50 per share in cash or a total equity value of $4.3 billion.
  • View the full release here: https://www.businesswire.com/news/home/20240211034242/en/
    “We are looking forward to advancing seladelpar by leveraging Gilead’s long-standing expertise in treating and curing liver diseases,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences.
  • Seladelpar is an investigational, oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, shown to regulate critical metabolic and liver disease pathways.
  • “Today’s agreement with Gilead is the culmination of years of focus and determination at CymaBay to advance seladelpar and bring new hope to people living with PBC and their families,” said Sujal Shah, President, and CEO at CymaBay Therapeutics.

CymaBay Announces FDA Acceptance of NDA and Priority Review for Seladelpar for the Treatment of Primary Biliary Cholangitis

Retrieved on: 
Monday, February 12, 2024

NEWARK, Calif., Feb. 12, 2024 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for seladelpar, an investigational treatment for the management of primary biliary cholangitis (PBC) including pruritus in adults without cirrhosis or with compensated cirrhosis (Child Pugh A) who are inadequate responders or intolerant to ursodeoxycholic acid. The FDA has granted priority review and set a Prescription Drug User Fee Act (PDUFA) target action date of August 14, 2024 and notified the company that it is not currently planning to hold an advisory committee meeting to discuss the application.

Key Points: 
  • PBC is a rare, chronic condition that can lead to inflammation and eventually liver cirrhosis.
  • People living with PBC can also experience symptoms that significantly impact their quality of life such as pruritus (itch) and fatigue.
  • Seladelpar is an investigational, potent, selective, orally active PPARδ agonist, or delpar, in development for PBC treatment.
  • "We are encouraged by the agency's decision to grant priority review for seladelpar, and its recognition of the significant need for new treatment options for people living with PBC.

Herbal medicinal product: Lecithinum ex soyaArray, D: Draft under discussion

Retrieved on: 
Saturday, February 10, 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 soya-bean lecithin.
  • Herbal medicines containing soya-bean lecithin are usually available in solid or liquid forms to be taken by mouth.
  • Soya-bean lecithin may also be found in combination with other herbal substances in some herbal medicines.
  • Key facts
    - Latin name
    - Lecithinum ex soya
    - English common name
    - Soya-bean lecithin
    - Botanical name
    Glycine max (L.) Merr.

Screen time can seriously harm your eyes: here’s how to avoid it

Retrieved on: 
Tuesday, February 6, 2024

The most common symptoms include irritated or itchy eyes, and a sensation of dryness or sand on the surface of the eye.

Key Points: 
  • The most common symptoms include irritated or itchy eyes, and a sensation of dryness or sand on the surface of the eye.
  • Screens are also a source of projected light, which raises the temperature of the eye’s surface and increases tear evaporation.
  • According to the data we gathered, increased screen time was linked to more severe dry eye symptoms.


Although reducing screen time is impossible in certain jobs, we can reduce irritation and problems by following certain recommendations. A basic understanding of the issue can also help us to look after our eyes.

Teardrops and eyelids

  • The eye’s surface is made up of eyelids, the tear film (the eye’s liquid coating), the cornea and the conjunctiva.
  • If any of them are affected, it can lead to irritation in the eye.
  • The eyelids are what keep the tear film evenly distributed, as well as providing protection.

Do you suffer from dry eye disease?

  • First and foremost, there is often no cause for panic: suffering certain symptoms of dry eyes does not necessarily mean you have dry eye disease.
  • A medical professional will determine whether this damage exists, and what further measures need to be taken.

How to reduce irritation and avoid dry eye disease


By taking precautions, we can ensure that screens work with us, not against us.
Screen height: It is always best to keep screens below eye level. This way the eyelids do not have to open as much, meaning less of the eye’s surface is exposed for prolonged periods.
Screen position and lighting: You should avoid light reflecting off screens, be it from a lamp or from a window behind where you sit. Excessive light forces us to concentrate harder, and therefore to blink less. This can be solved by using anti reflective filters.
Rest periods: Rest is your eyes’ best friend. A common rule of thumb is the 20-20-20 rule. For every 20 minutes of work, look at something 20 feet away (about 6 metres), for 20 seconds. This has been proven to reduce symptoms of eye dryness, as looking away from the screen re establishes our normal rate of blinking.
Environmental conditions: Low humidity, high temperatures, air currents from open windows or air conditioners, tobacco smoke and excessive air freshener can all be bad for eye health.
Eye hydration: Eye drops may be the best option on particularly intense working days. Avoid saline solutions, as their composition is not the same as the tear film. They lack the oils and proteins, and could destabilise this layer. The best option is single dose artificial tears, which do not contain preservatives and do not damage the eye.
The prevalence of screens in our society means that symptoms of dry eye disease are commonplace. If we confront this issue by taking the right steps, however, it doesn’t have to affect our quality of life.
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Pliant Therapeutics Announces Positive Safety and Exploratory Efficacy Data from the INTEGRIS-PSC Phase 2a Trial of Bexotegrast 320 mg in Patients with Primary Sclerosing Cholangitis and Suspected Liver Fibrosis

Retrieved on: 
Sunday, February 4, 2024

SOUTH SAN FRANCISCO, Calif., Feb. 04, 2024 (GLOBE NEWSWIRE) -- Pliant Therapeutics, Inc. (Nasdaq: PLRX) today announced 12-week interim data from the 320 mg dose group of INTEGRIS-PSC, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of bexotegrast in patients with primary sclerosing cholangitis (PSC) and suspected moderate to severe liver fibrosis. The 320 mg group met its primary and secondary endpoints demonstrating that bexotegrast was well tolerated over a 12-week treatment period and its plasma concentrations increased with dose. There was no dose relationship for adverse events. Pruritus and cholangitis occurred less frequently on bexotegrast than on placebo.

Key Points: 
  • The trial’s exploratory efficacy endpoints assessed changes in the liver fibrosis markers, Enhanced Liver Fibrosis (ELF) score and PRO-C3 levels, as well as liver biochemistry and magnetic resonance imaging (MRI) of the liver.
  • In addition, MRI imaging continued to show evidence of improved hepatocyte function and bile flow with bexotegrast at the 320 mg dose relative to placebo.
  • INTEGRIS-PSC is a multinational, randomized, dose-ranging, double-blind, placebo-controlled Phase 2a trial evaluating bexotegrast at once-daily oral doses of 40 mg, 80 mg, 160 mg, 320 mg or placebo for 12 weeks in 121 patients with PSC.
  • The 320 mg group enrolled 27 patients in the active arm and added 9 new patients to the pooled placebo arm.

Eton Pharmaceuticals Announces Commercial Availability of Ultra-Rare Disease Product Nitisinone Capsules

Retrieved on: 
Friday, February 2, 2024

DEER PARK, Ill., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing, acquiring, and commercializing products to address unmet needs in patients suffering from rare diseases, today announced the commercial availability of Nitisinone Capsules for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Please see important safety information below. Tyrosinemia type 1 is an ultra-rare condition that is estimated to impact fewer than 500 patients in the United States.

Key Points: 
  • We believe that our existing commercial infrastructure and strong patient support services should help us capture a meaningful percentage of the estimated $50 million annual Nitisinone market,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
  • Nitisinone Capsules are available exclusively through Optime Care, a specialty pharmacy dedicated to helping patients with rare diseases manage their conditions.
  • Optime Care will administer the Eton Cares Program in partnership with Eton Pharmaceuticals.
  • To report a suspected adverse event related to Nitisinone, contact Eton Pharmaceuticals, Inc. at: 1-855-224-0233 or the US Food and Drug Administration at www.fda.gov/medwatch or call 1-800-FDA-1088.

Takeda’s HYQVIA® Approved by European Commission as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Retrieved on: 
Monday, January 29, 2024

Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).

Key Points: 
  • Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).
  • The majority of AEs were mild or moderate, local, did not require suspension of infusions, and resolved without sequelae.
  • The most common (reported in >5% of patients) causally related AEs included headache and nausea, as well as local AEs including infusion site pain, erythema, pruritis, and edema.
  • HYQVIA first received approval from the EC for the treatment of primary immunodeficiency (PID) in 2013 as well as secondary immunodeficiency (SID) in 2020.8