Vitiligo

VYNE Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, May 11, 2023

BRIDGEWATER, N.J., May 11, 2023 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced financial results for the three months ended March 31, 2023 and provided a business update.

Key Points: 
  • “During the first quarter, we generated important new clinical data for VYN201, demonstrating positive safety results and pharmacokinetic results in healthy volunteers.
  • Furthermore, there were no clinically relevant treatment emergent adverse events, abnormal clinical laboratory results, electrocardiogram findings or patient withdrawals from the study.
  • VYNE expects to report topline 16-week data for all three cohorts from the Phase 1b trial in the third quarter of 2023.
  • VYNE also obtained rights to several other BD2-selective BET inhibitor compounds with attractive molecular profiles that the Company may develop, at its discretion, in the future.

Arcutis Announces First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, May 9, 2023

The Company anticipates submitting a supplemental New Drug Application (sNDA) to the FDA for ages 6 and above late in the third quarter or early in the fourth quarter of 2023.

Key Points: 
  • The Company anticipates submitting a supplemental New Drug Application (sNDA) to the FDA for ages 6 and above late in the third quarter or early in the fourth quarter of 2023.
  • In September 2022, Arcutis announced positive topline results from the ARRECTOR Pivotal Phase 3 trial for the treatment of scalp and body psoriasis.
  • Research and development (R&D) expenses for the quarter ended March 31, 2023 were $35.3 million compared to $40.6 million for the corresponding period in 2022.
  • Arcutis management will host a conference call and webcast today at 4:30pm ET to discuss the financial results for the quarter and provide a business update.

Barbie® Introduces Its First Doll with Down Syndrome, Further Increasing Representation in the Toy Aisle

Retrieved on: 
Tuesday, April 25, 2023

The Barbie doll with Down syndrome is meant to inspire all children to tell more stories through play.

Key Points: 
  • The Barbie doll with Down syndrome is meant to inspire all children to tell more stories through play.
  • Doll play outside of a child’s own lived experience can teach understanding and build a greater sense of empathy, leading to a more accepting world.
  • “It was an honor working with Barbie on the Barbie doll with Down syndrome,” said Kandi Pickard, NDSS President and CEO.
  • “This means so much for our community, who for the first time, can play with a Barbie doll that looks like them.

Incyte Announces European Commission Approval of Opzelura® (ruxolitinib) Cream for the Treatment of Non-Segmental Vitiligo with Facial Involvement in Adults and Adolescents

Retrieved on: 
Thursday, April 20, 2023

Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has granted a marketing authorization for Opzelura® (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced that the European Commission (EC) has granted a marketing authorization for Opzelura® (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
  • “The approval of Opzelura by the European Commission represents a significant advancement for people living with non-segmental vitiligo with facial involvement who, until now, had no approved medical treatment to address repigmentation,” said Hervé Hoppenot, Chief Executive Officer, Incyte.
  • Pivotal Phase 3 data supporting the European Commission decision were also published in The New England Journal of Medicine.
  • Vitiligo can occur at any age, although many patients with vitiligo will experience initial onset before the age of 305.

ACMI’s Goddess asks us rethink our gaze – and the bias it contains – when we look upon women on the screen

Retrieved on: 
Wednesday, April 19, 2023

Goddess has been in planning for five years, celebrating 120 years of women and the moving image.

Key Points: 
  • Goddess has been in planning for five years, celebrating 120 years of women and the moving image.
  • Curated in Australia by Bethan Johnson for ACMI, the museum will eventually travel it globally.
  • But the show also asks audiences to rethink what a “goddess” might be understood to be, do and mean.

Aussie goddesses

    • The exhibition, therefore, has something to say about – or from – this country and its talent.
    • The Australian lens shaping the selection, presentation and commentary about characters, stories and experiences is initially invoked by the soundscapes created by Melbourne-based composer, DJ and musician Chiara Kickdrum.
    • This continues further inside, in a darkened room where audiences see a montage of clips of stars speaking at awards and events about industry ageism, sexism, racism, advocacy for women and female courage.
    • It’s truth telling that this country needs to hear [so] we can move to the future with better understanding of who we are as a nation.

The body of the goddess

    • A key element of this exhibition is the spectacular display of the body of the screen goddess – from classical Hollywood to contemporary popular culture.
    • ACMI is framing the goddess not just by the tired “starlet” and “bombshell” tropes, but as a woman who pushes boundaries, questions norms and stereotypes.
    • The beautiful Harlow is a spokesperson for the skin condition vitiligo (where her skin has lost colour in parts).
    • Olivia Colman argues for the messy, imperfect body:
      I’m an actor, not a model and I think you should be able to look horrendous […] that’s what I love doing.

Incannex Appoints QPS to Advance CannQuit-N™ (Nicotine), CannQuit-O™ (Opioid) and Renecann™ Products in the USA and EU

Retrieved on: 
Friday, April 14, 2023

Over the years, QPS has adopted additional services, including Neuropharmacology, DMPK, Toxicology, Translational Medicine, Early Phase Clinical Research and Phase II – IV Clinical Research.

Key Points: 
  • Over the years, QPS has adopted additional services, including Neuropharmacology, DMPK, Toxicology, Translational Medicine, Early Phase Clinical Research and Phase II – IV Clinical Research.
  • QPS is currently drafting pre-investigational new drug (pre-IND) submissions for both the European Union’s European Medicines Agency (‘EMA’) and the US Food and Drug Administration (‘FDA’) for the CannQuit™ and ReneCann™ Products.
  • CEO and Managing Director, Mr Joel Latham said; “QPS is a perfect fit for us to develop these products across the globe.
  • Data collected by Eurofins on the quality and stability of the products will be key components of future regulatory packages.

Minghui Pharmaceutical Inc. Announces Phase 2 Clinical Trial Success of MH004 Cream as a Potential Best-in-Class Topical Treatment for Mild-to-Moderate Atopic Dermatitis and the FDA Clearance of its Global Phase 3 MRCT

Retrieved on: 
Friday, April 14, 2023

The study assessed safety, tolerability, pharmacokinetics (PK) and efficacy of two strengths of MH004 Cream.

Key Points: 
  • The study assessed safety, tolerability, pharmacokinetics (PK) and efficacy of two strengths of MH004 Cream.
  • "MH004 Cream is a topical cream containing a JAK inhibitor that was designed with Minghui's proprietary technology and formulation.
  • Based on the current phase 2 results, we plan to further pursue the development of MH004 Cream in atopic dermatitis as well as other dermatological diseases."
  • On April 1, the company received FDA IND approval for AD Phase 3 MRCTs after successful FDA communication and IND submission.

STRATA Skin Sciences Reports Record Fourth Quarter 2022 Revenue

Retrieved on: 
Friday, March 31, 2023

HORSHAM, Pa., March 31, 2023 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing and marketing innovative products for the treatment of dermatologic conditions, today announced financial results for the fourth quarter and full year ended December 31, 2022.

Key Points: 
  • Equipment revenues were $4.1 million for the fourth quarter of 2022, as compared to $2.3 million for the fourth quarter of 2021.
  • Selling and marketing costs for the fourth quarter of 2022 were $3.8 million, as compared to $3.7 million for the fourth quarter of 2021.
  • General and administrative costs for the fourth quarter of 2022 were $2.5 million, as compared to $2.6 million for the fourth quarter of 2021.
  • Other expense for the fourth quarter of 2022 were $0.2 million, compared to $0.2 million for the fourth quarter of 2021.

AMERICAN SKIN ASSOCIATION SPRING GALA CELEBRATES OUTSTANDING HONOREES

Retrieved on: 
Friday, April 7, 2023

NEW YORK, April 7, 2023 /PRNewswire/ -- On Tuesday evening, at The Plaza, American Skin Association (ASA) held their Spring Gala, where they presented awards to two outstanding honorees and celebrated another successful year of funding research and educating youth on skin health. The in-person gala returned after celebrating virtually during the pandemic to the delight of their loyal supporters and donors, including philanthropists, business leaders, and many renowned physicians from the field of dermatology.

Key Points: 
  • Gala honors Dermatology Giant Mark G. Lebwohl, MD and Pharmaceutical Leader LEO Pharma
    NEW YORK, April 7, 2023 /PRNewswire/ -- On Tuesday evening, at The Plaza, American Skin Association (ASA) held their Spring Gala, where they presented awards to two outstanding honorees and celebrated another successful year of funding research and educating youth on skin health.
  • Both honorees share in ASA's crucial mission of finding cures for skin diseases."
  • Recipients, who work on breakthrough efforts to prevent, detect, and treat skin cancer and other skin diseases, have gone on to become top researchers in dermatology.
  • ASA's educational contributions are part of a growing worldwide understanding of the importance of skin health awareness.

Incyte Announces Long-Term Extension Data from Phase 3 TRuE-V Program Demonstrating Long-Term Safety and Durability of Response of Opzelura® (Ruxolitinib) Cream in Vitiligo

Retrieved on: 
Saturday, March 18, 2023

The 104-week long-term extension (LTE) data build on the positive 52-week TRuE-V1 and TRuE-V2 results previously announced and published in The New England Journal of Medicine.

Key Points: 
  • The 104-week long-term extension (LTE) data build on the positive 52-week TRuE-V1 and TRuE-V2 results previously announced and published in The New England Journal of Medicine.
  • “The results presented today at AAD are significant because they provide important long-term efficacy and safety data for nonsegmental vitiligo patients treated with Opzelura,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte.
  • Approximately 29% of patients randomized to the withdrawal arm (i.e., applying vehicle cream) relapsed (
  • “Vitiligo is a chronic condition and these results demonstrate the long-term potential of this medical treatment for people with vitiligo who are interested in repigmentation.”