Dermatology Times May 2024 Recap

Clearances, Approvals, Updates, and Recommendations

FDA Approves A High-Concentration, Citrate-Free Version of Cyltezo, A Biosimilar to Humira

Adalimumab-adbm is now approved for use in various indications, including psoriasis, psoriatic arthritis, and hidradenitis suppurativa.

ICYMI: sBLA for Hyrimoz (Adalimumab-adaz) Approved as Interchangeable Biosimilar to Humira

Last week, the FDA approved an sBLA for Sandoz’s adalimumab-adaz in various strengths, including 10 mg/0.1 mL, 20 mg/0.2 mL, and 80 mg/0.8 mL.

Health Canada Accepts Arcutis Canada's Submission for Roflumilast Cream 0.15% in Atopic Dermatitis

Supportive data for roflumilast in adults and children 6 years of age and older stems from the INTEGUMENT studies.

BLAs, NDAs, and PDUFAs

FDA Updates PDUFA Date of Subcutaneous Nivolumab

The new action date is December 29, 2024.

Big Studies and Big Data

New Eblasakimab Data Shows Promise for Patients With AD and Inadequate Response to Dupilumab

ASLAN Pharmaceuticals presented new data this morning, including a 90% EASI score reduction.

AnaptysBio Announces Positive Topline Results from Phase 3 Trial of Imsidolimab for GPP

Patients who responded to imsidolimab in GEMINI-1 and who moved into GEMINI-2 maintained clear or almost clear skin.

Expert Panel Confirms Efficacy and Safety of Roflumilast Topical Foam for Seborrheic Dermatitis Across Diverse Hair Types

They are confident prescribing roflumilast to patients with diverse skin and hair characteristics, including those with a history of hair treatments.

Soligenix Announces Publication of Promising Comparative Data for HyBryte Synthetic Hypericin for CTCL

The results are both confirmatory and extend the response results from a prior phase 3 trial known as FLASH.

Deucravacitinib Demonstrates Sustained Efficacy and Safety in 4-Year Psoriasis Trial

Bristol Myers Squibb announced 70% of patients maintained significant improvement after 4 years with no new safety concerns.

IL-17 Pathway Linked to HIF-1-alpha Activation in Psoriasis

Researchers from NYU Langone recently published a study clarifying the role of HIF-1-alpha in inflammation and psoriasis, which has been unclear until now.

Results of Phase 3 BE HEARD Trials of Bimekizumab for HS Published in The Lancet

The Lancet data is the primary publication of bimekizumab results from BE HEARD I and BE HEARD II.

Soterios Announces New Positive Topline Results of STS-01 for Alopecia Areata

The phase 2 study achieved the primary end point of a >30% Severity of Alopecia Tool score improvement.

Market and Pharma News, Drug Watch

ASLAN Expands Collaboration with Zenyaku to Investigate Eblasakimab’s MOA Compared to Other Biologics in AD

The new research will compare eblasakimab to dupilumab and lebrikizumab.

Alpha Tau to Conduct Trial of Alpha DaRT Technology In Patients With Recurrent Squamous Cell Carcinoma

Robert Den, MD, and Alpha Tau are seeking motivated investigators who may be interested in participating in the trial.

Derm-Biome and TransBIOtech Awarded $450,000 ARD Grant Funding for Inflammatory Disease and Skin Aging Research

The awarded grant will span a total of 3 years.

VYNE Therapeutics Provides Updates on VYN201 for Nonsegmental Vitiligo and VYN202 for Inflammatory Diseases

VYNE expects to enroll the first patient with vitiligo in the phase 2b trial for VYN201 in the second quarter of 2024.

Merck Halts Dosing of Anti-TIGIT Antibody in KeyVibe-010 Melanoma Study

The analysis revealed a higher rate of discontinuations due to immune-mediated adverse experiences.

Lindus Health and Acinonyx Bio to Partner in Clinical Trial Evaluating a Benzoyl Peroxide Alternative

Acinonyx Bio's topical cream, ACX, targets Propionibacterium acnes.

MoonLake’s Sonelokimab Trial for HS Advances to Phase 3

VELA is the first phase 3 hidradenitis suppurativa trial to evaluate HiSCR75 as the primary end point.

Strides for Skin Health Equity

Study Is First to Analyze Content and Influence of Fairness Cream Commercials From South Asia

While 84% of commercials targeted female consumers and 77% utilized celebrity influence, less than half mentioned specific ingredients in skin lightening products.

Prebiotic Skin Care’s Effectiveness in AD for SOC Patients

A prebiotic cleanser and moisturizer regimen not only significantly alleviated the severity of atopic dermatitis and xerosis, but also uncovered crucial differences in symptom experiences.

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