September 13th 2024
Ebglyss is now approved for children and adults aged 12 years and older.
September 5th 2024
The rates of discontinuation due to inefficacy or adverse events for biosimilars and originators of etanercept and adalimumab were similar, according to an analysis of a prospective registry.
September 4th 2024
The PD-1/IL-2α bispecific antibody fusion protein is intended for patients with unresectable locally advanced or metastatic melanoma.
August 14th 2024
The overall reduction of tumor size in all lesions treated in part 2 was approximately 86%.
August 13th 2024
Galderma’s nemolizumab is the first approved monoclonal antibody specifically inhibiting the signaling of IL-31.
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.
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.
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.
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.
Eli Lilly Resubmits BLA for Lebrikizumab for the Treatment of Moderate to Severe AD
A decision from the FDA is expected in the second half of 2024.
FDA Accepts Dermavant’s sNDA for Tapinarof Cream 1% for Adults and Children With AD
The FDA’s PDUFA date is expected in quarter 4 of 2024.
Upadacitinib Outperforms Dupilumab in Primary and Secondary End Points in Head-to-Head AD Study
In LEVEL-UP, upadacitinib demonstrated superiority over dupilumab in achieving EASI-90 and little to no itch at week 16.
ASLAN Announces Positive Phase 2 Results of Eblasakimab in Dupilumab-Treated Patients With AD
Sixty percent of dupilumab-treated patients with AD treated with 400mg of eblasakimab weekly achieved EASI-90 after 16 weeks.
MoonLake Immunotherapeutics and Komodo Health to Partner to Improve Research on Inflammatory Skin Conditions
MoonLake’s sonelokimab is being evaluated for hidradenitis suppurativa, psoriasis, and psoriatic arthritis.
Apremilast Demonstrates Consistent Safety and Efficacy in Children with Moderate to Severe Plaque Psoriasis at 52 Weeks
Loretta Fiorillo, MD, FRCPC, reviews key data points from the phase 3 SPROUT study.
Pelthos Therapeutics Launches to Accelerate Commercialization of Treatment for Molluscum Contagiosum
The new launch is set to bring berdazimer topical gel, 10.3% to adults and pediatric patients over the age of 1 with molluscum contagiosum faster.
ARCA Biopharma and Oruka Therapeutics Agree to Merger
The merger will focus on advancing Oruka’s portfolio of novel biologics for the treatment of chronic skin diseases.
Soligenix and European Medicines Agency Settle on Design of Second Placebo-Controlled Trial of HyBryte in CTCL
The agreement for a second confirmatory trial comes after a successful phase 3 FLASH study that yielded positive outcomes and efficacy.
Recapping March Dermatology Biosimilar News
The biosimilar landscape experienced significant activity, marked by fresh data from conferences, novel findings regarding adalimumab biosimilars, and more.
Incyte and CMS Collaborate to Develop Povorcitinib in Numerous Chinese Regions
Povorcitinib is being evaluated for non-segmental vitiligo, hidradenitis suppurativa, prurigo nodularis, asthma, and chronic spontaneous urticaria.
UCB Receives Positive CHMP Opinion for Bimekizumab for Moderate to Severe HS
If approved, bimekizumab will be the first IL-17A and IL-17F inhibitor approved in Europe for hidradenitis suppurativa.
FDA Accepts Citius's Resubmitted BLA for Denileukin Diftitox for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma
The FDA has assigned a Prescription Drug User Fee Act target action date for August 13.
FDA Accepts Journey Medical’s NDA for DFD-29 for Rosacea
The anticipated PDUFA date is November 4, 2024.
Late-Breaking Data: Povorcitinib Significantly Improves Itch and Lesions in Prurigo Nodularis
Shawn Kwatra, MD, shares positive updates on phase 2 oral povorcitinib for prurigo nodularis at AAD 2024.
Tapinarof Cream 1% Efficacious in Adults and Children With Skin of Color Down to 2 Years With AD
New data was presented at the American Academy of Dermatology Annual Meeting in San Diego, California.
Zabalafin Hydrogel Significantly Improves Itch in Phase 2a Trial for AD
Alphyn’s first-in-class therapeutic is designed to treat the immune system component, and more specifically the bacterial component, of AD.
Lloyd Miller, MD, PhD: Delving Into JNJ-2113 Data for Plaque Psoriasis
Miller, Vice President, Immunodermatology Disease Area Leader, Johnson & Johnson, spoke with Dermatology Times about recently published data supporting JNJ-2113's potential in this indication.
Lifileucel Receives FDA Accelerated Approval for Advanced Melanoma
Lifileucel is a tumor-derived autologous T cell immunotherapy.
FDA Accepts Galderma’s BLA for Nemolizumab for the Treatment of Prurigo Nodularis and Atopic Dermatitis
The FDA has also granted nemolizumab Priority Review for prurigo nodularis.
Dermavant Submits sNDA to FDA for Tapinarof Cream 1% to Treat AD Down to 2 Years
Tapinarof cream demonstrated highly statistically significant improvement in the primary end point of vIGA-AD treatment success over vehicle at week 8.
Targeted Oral Peptide JNJ-2113 Led to Significant PASI, IGA Responses in Phase 2b Trial for Plaque Psoriasis
Data from the FRONTIER 1 clinical trial were recently published in the New England Journal of Medicine.
Marcelo Bigal, MD, PhD: VENT-03's Modality Offers Hope for Targeted Therapy in Skin Disorders
Marcelo Bigal, MD, PhD, discusses VENT-03's potential as a small molecule therapeutic in dermatology, among other fields.
Guselkumab Significantly Clears Scalp Psoriasis in Patients With Skin of Color in Phase 3b VISIBLE
The VISIBLE clinical program will create a longitudinal collection of more than 20,000 clinical images across all skin tones.
Celltrion USA Launches 80 mg Dose of Adalimumab Biosimilar, Yuflyma
The high-concentration and citrate-free biosimilar was first available in a single 40 mg dose.
Lutikizumab Demonstrates Positive Results in Phase 2 Trial for Hidradenitis Suppurativa
Higher response rates were observed in patients treated with lutikizumab. The drug will now advance to phase 3 clinical trials.