Dermatology Times January 2024 Recap

FDA Clearances, Approvals, Updates, and Recommendations

FDA Approves Berdazimer Gel, 10.3% for the Treatment of Molluscum Contagiosum

The approval marks a milestone for patients ages 1 year of age and older who face the persistent, highly contagious condition.

FDA Clears DermaSensor Device for Skin Cancer Detection

The hand-held DermaSensor uses an AI algorithm to noninvasively evaluate suspicious skin lesions for cancer.

FDA Updates Dupilumab Label With Hand, Foot Atopic Dermatitis Involvement

The FDA has added efficacy and safety data for patients ages 12 years and older with uncontrolled moderate-to-severe atopic dermatitis with hand and/or foot involvement.

FDA Provides New Industry Recommendations for the Reformulation of Drug Products Containing Carbomers Manufactured With Benzene

Currently, some United States Pharmacopeia carbomer monographs allow unacceptable levels of benzene.

BLAs and NDAs

FDA Accepts Accord BioPharma's BLA for Proposed Ustekinumab Biosimilar DMB-3115

The BLA submission for DMB-3115 is rooted in phase III multi-regional clinical trials focusing on plaque psoriasis patients. The results demonstrated a high similarity between DMB-3115 and ustekinumab in terms of quality, safety, and efficacy.

Journey Submits New Drug Application for DFD-29 for Rosacea

The filing is supported by positive phase 3 clinical trial data.

Big Studies and Big Data

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.

Dosing Starts in Phase 3 ASC40 Trial For Acne Treatment

Investigators explained how the trial is structured to inhibit facial sebum production and inflammation among nearly 500 study participants.

Melanoma Overdiagnosis Rising Among White Patients

Almost 90% of white men and 85% of white women who received a diagnosis of melanoma in 2018 were likely overdiagnosed, according to a new study.

Phase 1 Trial Underway for EVO756 in Adults With Chronic Spontaneous Urticaria

The study will evaluate the MRGPRX2 antagonist in healthy adults and adults with CSU.

Market and Pharma News, Drug Watch

LEO Pharma Completes Key Asset Acquisition, Including TMB-001, From Timber Pharmaceuticals

The finalized acquisition comes 5 months after Timber Pharmaceuticals filed for chapter 11 bankruptcy.

Roflumilast Foam, 0.3% for Seborrheic Dermatitis Launches in US

Zoryve was approved for the treatment of seborrheic dermatitis in patients ages 9 years and older in December.

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.

New Hyperhidrosis Treatment Approval Expected in Mid-2024 Following FDA Delay

The novel topical anticholinergic/antimuscarinic will offer an additional strategy for the treatment of underarm hyperhidrosis.

Market Study Reports Secukinumab Emerged as a Leading Treatment for HS

To gauge the impact and evolving landscape of HS treatment post-secukinumab approval, Spherix Global Insights conducted research with more than 100 US dermatologists.

B-VEC and Ycanth Receive Permanent J-Codes

Krystal Biotech Receives Permanent J-code for B-VEC for the Treatment of DEB

J3401 went into effect on January 1, 2024.

Verrica Receives Permanent J-Code for Ycanth for Molluscum Contagiosum

The Centers for Medicare & Medicaid Services has issued a permanent J-code for the first and only FDA-approved treatment for molluscum contagiosum.

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