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.
August 8th 2024
The approval is supported by positive phase 3 data for Lymphir in this indication.
Q&A: Alumis Inc. Initiates Phase 3 Clinical Program for ESK-001 in Plaque Psoriasis
Alumis' Martin Babler shared insights into the program for the TYK2 inhibitor and the company's next steps for its development.
Turn Therapeutics Reports Significant IGA and Cytokine Inhibition, Advances to Plans for In-Human Trial
This article represents the first time the news has been shared with the public. Turn's Founder and CEO, Bradley Burnam, shares details.
SLIDESHOW: Overview of July 2024 FDA Approvals
Take a deep dive into the 3 approvals for various dermatological conditions this month.
Roflumilast Cream 0.15% for Atopic Dermatitis Now Commercially Available
Approved down to the age of 6, the treatment is covered by 2 pharmacy benefit manager contracts to provide timely coverage.
Emerging Therapeutic for Non-Segmental Vitiligo: Merck’s MK-6194
Iltefat Hamzavi, MD, discusses the REGINA 007 phase 2 trial evaluating MK-6194 for the treatment of non-segmental vitiligo.
The FDA Approves Deuruxolitinib for Severe Alopecia in Adults
Along with the approval, Sun Pharma is introducing an access program to assist eligible patients in starting and adhering to the treatment.
Arcutis Submits sNDA for Roflumilast Foam to FDA for Scalp and Body Psoriasis
The submission to the FDA is supported by positive results from the ARRECTOR phase 3 trial.
FDA Approves Roflumilast Cream 0.15% For Atopic Dermatitis in Patients Aged 6 Years and Older
Patrick Burnett, MD, PhD, provides insights into the significance of Arcutis’ roflumilast cream 0.15% formulation and its impact on pediatric patients.
Arcutis Still Awaiting FDA Action for Roflumilast Cream 0.15% for AD
The planned PDUFA data was July 7, 2024.
VYNE's Iain Stuart, PhD, Talks Promise of VYN202 and BET Inhibition in Inflammatory and Psoriatic Disease
Iain Stuart, PhD, discusses VYN202's status and potential in psoriasis and immuno-inflammatory diseases.
FDA Approves Biosimilar Ustekinumab-ttwe for All Indications of Reference Medicine
Pyzchiva will be commercialized by Sandoz in the United States.
FDA Grants Investigational New Drug Clearance for Ensemble No.2 for Phase 1 Atopic Dermatitis Trial
Ensemble No.2, or ENS-002, is an investigational live biotherapeutic product first detected by Concerto Biosciences using its kChip technology.
Health Canada Authorizes Lebrikizumab for Moderate to Severe Atopic Dermatitis in Patients 12 Years and Older
Authorization for Eli Lilly's Ebglyss is based on positive results from the ADvocate 1, ADvocate 2, and ADhere studies.
FDA Approves Sofpironium (Sofdra) as First and Only Chemical Entity for Primary Axillary Hyperhidrosis
Botanix Pharmaceuticals announced the approval of its sofpironium topical gel, 12.45% for adults and children ages 9 and older.
SFA-002 Shows Promise in Early Clinical Trial Psoriasis Cohorts
Stefan Weiss, MD, MBA, explains next steps for the oral treatment after the completion of phase 1b enrollment.
FDA Approves Tralokinumab Autoinjector for Adults With Moderate to Severe Atopic Dermatitis
LEO Pharma's Adbry, a single-dose autoinjector, is expected to become available to patients in the coming months.
Late-Breaker: Roflumilast Cream 0.15% Demonstrates Continued Improvement in AD Symptoms Through 56 Weeks
Roflumilast cream 0.15% is being evaluated for patients with mild to moderate atopic dermatitis down to 6 years.
SDPA Poster Reports Positive Phase 3 Results of Dupilumab for PN
Researchers found dupilumab improved itch and skin lesions regardless of atopic disease status in patients with PN.
VYNE Therapeutics Initiates Phase 2b Trial of BET Inhibitor VYN201 for Vitiligo
The primary efficacy endpoint is the proportion of subjects achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index.
Moderna and Merck Announce New 3-Year Date for mRNA-4157 Combined With Pembrolizumab for High-Risk Stage III/IV Melanoma
Phase 3 trials have been initiated in patients with high-risk melanoma.
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.
May Pipeline Roundup
The month of May has been full of pipeline news, including updates on VYN201 for nonsegmental vitiligo, imsidolimab for GPP, sonelokimab for HS, and more.
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.
FDA Updates PDUFA Date of Subcutaneous Nivolumab
The new action date is December 29, 2024.
Baldo Scassellati Sforzolini, MD, PhD, MBA: Expanding Nemolizumab’s Access
Scassellati Sforzolini discusses the significance of Galderma’s nemolizumab receiving 4 additional filing acceptances for prurigo nodularis and atopic dermatitis.
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.
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.
Lindus Health and Acinonyx Bio to Partner in Clinical Trial Evaluating a Benzoyl Peroxide Alternative
Acinonyx Bio's topical cream, ACX, targets Propionibacterium acnes.
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.
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.