September 26th 2023
Abeona Therapeutics is seeking Priority Review and approval of the therapy for patients with recessive dystrophic epidermolysis bullosa.
September 12th 2023
The IL-17A inhibitor did not meet its phase 2b/3 clinical trial primary end point.
The submission follows the announcement of recent long-term data of the drug in patients ages 6 years and older.
August 1st 2023
Both companies are hoping to make a positive impact in the neoadjuvant setting of cutaneous squamous cell carcinoma.
July 27th 2023
V940-001 is the first phase 3 study of a planned comprehensive clinical development program initiated after the positive primary analysis of the phase 2b KEYNOTE-942/mRNA-4157-P201 trial.
Ritlecitinib and Nivolumab Receive Positive CHMP Opinions
Both therapies for alopecia areata and completely resected stage IIB/C melanoma could be approved by the EC for patients aged 12 years or older.
VP-102 Now Approved for the Treatment of Molluscum Contagiosum
Verrica’s VP-102 is the first FDA-approved treatment for molluscum lesions.
Novan Inc to Sell All Assets and File for Chapter 11 Protection
The goal of a January 5, 2024, PDUFA date for berdazimer gel, 10.3%, continues with pre-approval inspection already complete.
Alphyn Biologics Shares Positive Interim Results of Phase 2a Trial for AD With Secondary Bacterial Infection
AB-101a is a new topical treatment being investigated for mild, moderate, and severe atopic dermatitis and its immune system component.
Cyltezo Added to Express Scripts' National Preferred Formulary
Coverage for eligible patients began July 12, 2023.
New Positive Topline Results From Ruxolitinib Phase 3 Trial for Pediatric AD
The TRuE-AD3 study met its primary endpoint of IGA-TS improvement from baseline at week 8.
DFD-29 Achieves Phase 3 Co-Primary and All Secondary Endpoints for Papulopustular Rosacea Treatment
Based on the positive topline phase 3 results, Journey Medical plans to submit a New Drug Application to the FDA in the second half of 2023.
Alan Mendelsohn, MD, Reviews Phase 3 TMB-001 PK Data for Congenital Ichthyosis
New pharmacokinetic phase 3 data will be presented at the 2023 Society for Pediatric Dermatology meeting next week.
Payers Reveal Most Significant Factors Impacting Biosimilar Coverage Decisions
It was found that cancer treatment, pediatric population, and coverage restriction of reference products were revealed as some of the strongest factors associated with biosimilar coverage decisions by US commercial health plans relative to reference products.
Cyltezo Biosimilar Launches Today in the US
Boehringer Ingelheim’s Cyltezo is the first and only FDA-approved interchangeable biosimilar to adalimumab.
Amlitelimab Reaches Phase 2b Primary Endpoint in AD Management
Sanofi’s investigational anti-OX40-ligand monoclonal antibody showed statistically significant improvement in signs and symptoms of AD in adults.
Sandoz Launches Action Plan to Increase Global Biosimilar Access
The Act4Biosimilars Action Plan aims to highlight key challenges preventing patient access to biosimilars and outline steps to help overcome them.
Dermatology Pipeline Updates: Plaque Psoriasis, Atopic Dermatitis and More
The current dermatology pipeline includes a wide range of medication classes, from Janus kinase (JAK) inhibitors to tumor necrosis factor inhibitors, to phototherapeutics
Cutiss, DenovoSkin Changing the Standard of Burn Care Across the Globe
CEO Daniela Marino, PhD, emphasizes that the Switzlerand based company has received Orphan Drug Designation from the Swissmedic, EMA, and FDA, for its personalized human skin graft.
Amgen to Present New MOSAIC Phase 4 Data at EULAR 2023
Apremilast is being examined for the treatment of psoriatic arthritis.
FDA Approves Yuflyma, the Ninth Adalimumab Biosimilar
Yuflyma will be available to US patients in July 2023.
FDA Approves Cyltezo Autoinjector Pen
The adalimumab biosimilar will be commercially available in the US starting July 1, 2023.
B-VEC Approved for the Treatment of Dystrophic Epidermolysis Bullosa
Beremagene geperpavec is the first FDA-approved treatment for DEB, a rare and burdensome disease.
Four Abstracts on Eblasakimab and Farudodstat to be Presented at 1st International Societies for Investigative Dermatology Meeting
ASLAN Pharmaceuticals will present 2 late-breaking abstracts and 2 additional abstracts.
European Commission Approves Ruxolitinib Cream for Non-Segmental Vitiligo
Ruxolitinib is the first and only approved treatment for repigmentation in the European Union.
FDA Issues Second CRL for Alvotech’s Adalimumab Biosimilar
Approval has been pushed back to June 28, 2023.
New Safety and Efficacy Data of Ritlecitinib for Alopecia Areata Published in The Lancet
Ritlecitinib was found to be effective and well-tolerated in patients aged 12 years and older.
FDA Accepts Roflumilast Foam NDA for the Treatment of Seborrheic Dermatitis
The expected PDUFA date is December 16, 2023.
Doris Day, MD, Discusses Primary Axillary Hyperhidrosis and Brella SweatControl Patch
Brella received FDA clearance last week for improving excessive underarm sweating.
Phase 2 Data of Personalized Cancer Vaccine With Adjuvant Pembrolizumab for Resected High-Risk Melanoma
Data from the KEYNOTE-942 trial was presented at the American Association for Cancer Research Annual Meeting 2023.
The JAK Inhibitor Pipeline Builds in Dermatology
Eight JAK inhibitors are approved by the FDA to treat autoimmune, inflammatory, and allergic conditions.
FDA Clears Brella SweatControl Patch for Reduced Primary Axillary Hyperhidrosis
Patients can achieve reduced excessive underarm sweating after one in-office treatment.
Pembrolizumab Plus Lenvatinib Phase 3 Melanoma Trial Discontinued
Merck and Eisai discontinued the trial based on recommendations of an independent data monitoring committee.
First Dosing of Patient in Phase 2 Study Evaluating VP-315 for BCC
Verrica Pharmaceuticals is developing a potentially first-in-class oncolytic peptide.
Q1 Accepted NDAs and sBLAs to Keep a Watchful Eye On
Three major NDAs and sBLAs were accepted by the FDA in Q1 of 2023, with PDUFA dates set in 2023 and 2024.
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