Sol-Gel and Mayne Pharma Announce $16 Million Deal for EPSOLAY and TWYNEO Rights in the U.S.
Sol-Gel Technologies has entered into a $16 million agreement with Mayne Pharma for the sale and exclusive license of U.S. rights to dermatology products EPSOLAY and TWYNEO, extending the company's cash runway into Q1 2027.
Galderma's Relfydess Shows Rapid, Long-Lasting Improvement for Frown Lines in Phase IIIb Trial
Phase IIIb RELAX trial data demonstrates rapid onset of aesthetic improvement with Relfydess (RelabotulinumtoxinA) for frown lines, with 40% of subjects reporting improvement on Day 1.
FDA Approves Multiple Breakthrough Therapies: Crenessity for CAH, Unloxcyt for Skin Cancer
• The FDA has approved Neurocrine's Crenessity as an adjunct therapy for classic congenital adrenal hyperplasia, offering patients a way to reduce steroid treatment burden. • Checkpoint Therapeutics received FDA approval for Unloxcyt to treat advanced cutaneous squamous cell carcinoma, targeting a $1 billion market opportunity. • Galderma's Nemluvio gains FDA approval for moderate-to-severe atopic dermatitis in patients 12 and older, with projected peak annual sales exceeding $2 billion.
Galderma's Nemolizumab (Nemluvio) Receives FDA Approval for Moderate-to-Severe Atopic Dermatitis
• The FDA has approved Nemluvio (nemolizumab) for moderate-to-severe atopic dermatitis in patients 12 years and older when topical treatments are inadequate. • Nemolizumab is the first monoclonal antibody targeting IL-31 receptor alpha, offering a novel approach to reduce itch and inflammation associated with atopic dermatitis. • Clinical trials showed significant improvements in skin clearance, itch relief, and sleep disturbance with nemolizumab in combination with topical treatments. • Galderma anticipates peak sales of nemolizumab to exceed $2 billion, with potential blockbuster status by the end of 2027.
Galderma's Phase III OLYMPIA 1 Trial Results Show Nemolizumab Significantly Improves Prurigo Nodularis Symptoms
• Newly published results in JAMA Dermatology demonstrate nemolizumab monotherapy significantly improved itch intensity and skin lesions in patients with moderate-to-severe prurigo nodularis compared to placebo. • The OLYMPIA 1 trial showed rapid response as early as Week 4, with over six times more nemolizumab-treated patients achieving itch response and twenty times more reaching an itch-free or nearly itch-free state compared to placebo. • Based on the OLYMPIA clinical trial program, nemolizumab (Nemluvio®) received FDA approval for adult prurigo nodularis in August 2024, with additional regulatory reviews ongoing worldwide.
FDA Approves Journey Medical's Emrosi for Inflammatory Lesions of Rosacea
The FDA has approved Journey Medical's Emrosi (minocycline hydrochloride) for treating inflammatory lesions of rosacea in adults.
Clascoterone, Trifarotene, and Tazarotene Show Comparable Efficacy in Acne Treatment: Meta-Analysis
A meta-analysis of randomized controlled trials reveals that clascoterone, trifarotene, and tazarotene demonstrate similar efficacy in treating moderate to severe acne vulgaris.
RelabotulinumtoxinA Shows Long-Term Safety and Efficacy in Phase III Trial for Facial Lines
Galderma's RelabotulinumtoxinA (Relfydessâ„¢) demonstrates sustained safety and efficacy in treating frown lines and crow's feet with repeated injections over 12 months.
Nemolizumab Shows Long-Term Efficacy in Atopic Dermatitis and Prurigo Nodularis
Interim analysis of the ARCADIA long-term extension study shows continuous nemolizumab treatment leads to increasing improvements in atopic dermatitis symptoms over 56 weeks.
Dermatology Experts Highlight Advances in Treatment and Clinical Trial Diversity
Experts at the Skin of Color Update 2024 emphasized the importance of diversity in clinical trials to address health disparities and improve data for all patient populations.