Robust Pipeline of 50+ Therapies Reshaping Moderate to Severe Atopic Dermatitis Treatment Landscape
• The moderate to severe atopic dermatitis market is experiencing significant growth with 45+ companies developing over 50 pipeline therapies, driven by rising global prevalence and increased awareness of the condition.
• Recent advancements include promising biologics like rezpegaldesleukin (granted FDA fast-track designation), JAK inhibitors such as VC005 and QY201, and novel mechanisms targeting IL-4/IL-13 pathways, offering new hope for patients with inadequate response to current treatments.
• Key players including Nektar Therapeutics, Corvus Pharmaceuticals, and Apogee Therapeutics are advancing clinical trials with significant milestones expected in late 2025, potentially transforming the therapeutic landscape for this chronic inflammatory skin condition.
Saudi Arabia Seeks to Localize Insulin and GLP-1 Production Through Novo Nordisk Partnership
• Saudi Industry Minister Bandar Al-Khorayef is visiting Denmark to strengthen pharmaceutical partnerships, with a focus on bringing insulin and GLP-1 production to Saudi Arabia through collaboration with Novo Nordisk.
• The initiative is part of a strategic partnership between Novo Nordisk and Saudi Arabia's Public Investment Fund via Lifera, aiming to establish local production capabilities for critical diabetes and obesity medications.
• Al-Khorayef's tour included visits to Novo Nordisk's advanced insulin production facilities and the Technical University of Denmark Science Park, highlighting Saudi Arabia's commitment to pharmaceutical technology transfer.
Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges
• Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions.
• The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success.
• This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.
LEO Pharma's Temtokibart Shows Promising Results in Phase 2b Trial for Moderate-to-Severe Atopic Dermatitis
• LEO Pharma's investigational IL-22RA1 antagonist temtokibart achieved positive results for the primary endpoint at the three highest doses in a Phase 2b trial for moderate-to-severe atopic dermatitis.
• The treatment demonstrated a favorable safety profile with most adverse events being non-serious, mild to moderate in severity, and not considered treatment-related, supporting its potential as a novel therapeutic approach.
• Temtokibart represents a different mechanism of action by targeting the IL-22 pathway, potentially addressing unmet needs in atopic dermatitis treatment where current options may be insufficient.
LEO Pharma's Delgocitinib Cream Outperforms Alitretinoin in Landmark DELTA FORCE Trial for Chronic Hand Eczema
• The phase 3 DELTA FORCE trial demonstrated superior efficacy of topical delgocitinib cream over oral alitretinoin capsules for severe chronic hand eczema, with results published in The Lancet.
• Delgocitinib cream, a pan-JAK inhibitor, achieved all primary and secondary endpoints with fewer treatment-emergent adverse events compared to alitretinoin, the only currently approved treatment for severe CHE in Canada.
• The investigational topical treatment is already approved in Europe, UK, Switzerland, and UAE, while remaining under regulatory review in Canada and the United States.
FDA Commissioner Makary Proposes New Approval Pathway for Rare Disease Drugs
• FDA Commissioner Marty Makary has announced plans for a new regulatory pathway to expedite approvals for rare disease treatments, potentially without requiring randomized controlled trials.
• The proposed "plausible mechanism" pathway would include conditional approvals for therapies with scientifically sound physiological rationales, coupled with a comprehensive patient surveillance system.
• Makary also addressed public distrust in health authorities, announcing plans to replace the self-reported VAERS system with a more robust "Health Information Exchange" to better monitor treatment complications.
Novo Nordisk Warns US Price Negotiations Will Impede Research as Three GLP-1 Drugs Face Scrutiny
• Novo Nordisk has expressed strong concerns that three of its best-selling GLP-1 drugs have been included in upcoming US price negotiations, warning this will slow down research and development efforts.
• The Danish pharmaceutical giant faces increasing pressure from US payers amid a shifting market landscape, forcing the company to adapt its strategy toward next-generation innovation and expansion in emerging markets.
• While navigating pricing challenges, Novo Nordisk continues to advance its pipeline, including semaglutide formulations and digital insulin delivery systems, to maintain its leadership position in diabetes and obesity treatment.
Delgocitinib Cream Shows "Super-Response" in Nearly Half of Chronic Hand Eczema Patients
• Nearly 50% of patients with moderate to severe chronic hand eczema achieved a "deep response" with delgocitinib cream 20 mg/g by week 16, demonstrating significant relief from disease burden.
• Approximately 25% of patients exhibited "consistent response" with sustained improvement in pain or itch scores, maintaining ≥75% improvement in disease severity throughout the treatment period.
• One-third of patients who achieved complete clearance maintained their results even after stopping treatment, suggesting delgocitinib provides lasting therapeutic benefit beyond the application period.
Topical Drug Delivery Market Set to Reach $454.93 Billion by 2031 as Targeted Delivery Technologies Advance
• The global topical drug delivery market is projected to grow from $226.31 billion in 2023 to $454.93 billion by 2031, representing a CAGR of 9.1%, driven by increasing demand for non-invasive treatment options.
• Targeted drug delivery devices market is expected to grow at a faster CAGR of 19.7% through 2035, with intratumoral delivery dominating the segment and immunotherapy applications leading current market share.
• Technological advancements in drug delivery systems are enabling more precise administration to specific organs, with devices targeting the brain showing promising growth potential despite breast-targeted devices currently driving overall market volume.
Novel Oral Psoriasis Therapies Show Promise: TYK2 Inhibitors Lead Breakthrough Advances
• Deucravacitinib demonstrates superior efficacy over apremilast in psoriasis treatment, with over 53% of patients achieving significant skin clearance at week 16.
• Apremilast maintains its position as a key therapy for mild-to-moderate psoriasis, with 21% of bio-naïve patients achieving treatment goals in the ADVANCE trial.
• Next-generation oral therapies, including JNJ-77242114 and zasocitinib, show promising results in clinical trials, potentially expanding treatment options for psoriasis patients.
Phase 3 Trial Shows Delgocitinib Cream Effective for Adolescent Chronic Hand Eczema
• LEO Pharma's delgocitinib 20 mg/g cream demonstrated significant efficacy in Phase 3 DELTA TEEN study for adolescents aged 12-17 with chronic hand eczema.
• The topical pan-JAK inhibitor met both primary and secondary endpoints in treating moderate to severe chronic hand eczema, addressing an important unmet medical need.
• The positive results support potential regulatory submissions for adolescent use of delgocitinib, which is already approved for adults in several regions.
United Therapeutics' UKidney Xenotransplant Trial Receives FDA Clearance
• United Therapeutics received FDA clearance for its IND application to begin clinical trials for UKidney, a gene-edited pig kidney, marking a significant step in xenotransplantation.
• The phase 1/2/3 trial will enroll ESRD patients, including those ineligible for traditional transplants and those unlikely to receive a kidney within five years.
• UKidney features 10 gene edits to enhance compatibility and reduce rejection, offering a potential alternative to dialysis for patients with limited options.
• The trial's primary endpoints include patient and UKidney survival rates, changes in glomerular filtration rate, and quality of life improvements over a 24-week period.
EU Committee Recommends Approval of Pfizer and Genmab's Tivdak for Cervical Cancer
• The European Medicines Agency's CHMP has recommended marketing authorization for Tivdak, an antibody-drug conjugate developed by Pfizer and Genmab.
• Tivdak is intended for the treatment of recurrent or metastatic cervical cancer in adult patients.
• Tivdak has already been approved in the United States for the same indication, recurrent or metastatic cervical cancer.
• The positive CHMP opinion paves the way for final approval by the European Commission, expanding access to this therapy.
FDA Approves Monthly IV Maintenance Dosing for Leqembi, Eases Treatment Burden for Alzheimer's Patients
• The FDA has approved a monthly intravenous (IV) maintenance dose for Leqembi, offering a more convenient treatment schedule for early Alzheimer's disease.
• Patients completing the initial 18-month biweekly IV treatment can transition to monthly dosing, potentially improving long-term adherence and quality of life.
• Approval is based on data modeling showing sustained clinical and biomarker benefits with monthly dosing, addressing the continuous neurotoxic processes of Alzheimer's.
• Leqembi, developed by Eisai and Biogen, is now approved in multiple countries, offering a significant advancement in managing early Alzheimer's disease.
Nektar's Rezpegaldesleukin Receives FDA Fast Track for Atopic Dermatitis Treatment
• The FDA has granted Fast Track designation to rezpegaldesleukin for moderate-to-severe atopic dermatitis in patients 12 years and older.
• Rezpegaldesleukin targets the interleukin-2 receptor complex, stimulating regulatory T cell proliferation to restore immune balance.
• Phase 2b REZOLVE-AD study has completed enrollment, with topline data expected in Q2 2025, evaluating EASI score improvements.
• Fast Track designation allows for more frequent interactions with the FDA, potentially accelerating the drug's development and approval.
Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments
• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions.
• Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways.
• These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets.
• The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.
FDA and EMA Accept Biogen's Application for Higher-Dose Nusinersen (Spinraza) in SMA
• The FDA and EMA have accepted applications for a higher dose regimen of nusinersen (Spinraza) for treating spinal muscular atrophy (SMA).
• The new regimen involves a faster loading phase with two 50 mg doses and a higher maintenance dose of 28 mg every four months.
• The applications are based on the DEVOTE study, demonstrating potential clinical benefits and a safety profile consistent with the approved 12 mg regimen.
• If approved, the higher dose regimen could provide meaningful improvements for individuals with SMA, addressing unmet needs in the community.
Delgocitinib Shows Promise for Adolescent Chronic Hand Eczema in Phase 3 Trial
• LEO Pharma's DELTA TEEN trial demonstrated delgocitinib cream's efficacy in adolescents aged 12-17 with moderate to severe chronic hand eczema (CHE).
• The trial met its primary endpoint, showing significant improvement in CHE symptoms compared to the cream vehicle after 16 weeks.
• Delgocitinib, a topical pan-JAK inhibitor, could address the unmet need for approved therapies for adolescent CHE, improving their quality of life.
• Detailed results are expected to be presented at a future scientific meeting and submitted for publication.
LEO Pharma's Adtralza/Adbry Shows Promise in Adolescent Atopic Dermatitis Treatment
• LEO Pharma's Adtralza (tralokinumab) has been approved by the MHRA and EC for treating moderate-to-severe atopic dermatitis in adolescents aged 12-17 years.
• Long-term data from the ECZTEND study demonstrates Adbry (tralokinumab-ldrm) maintains clear or almost clear skin in atopic dermatitis patients for up to six years.
• Adbry, which targets interleukin-13, has shown a significant reduction in eczema severity and is available as a single-dose autoinjector for convenient administration.
LEO Pharma's Delgocitinib Cream Receives FDA Filing Acceptance for Chronic Hand Eczema Treatment
• The FDA has accepted LEO Pharma's New Drug Application for delgocitinib cream, a potential first-in-class treatment for chronic hand eczema (CHE) in the U.S.
• Delgocitinib cream, a topical pan-JAK inhibitor, could become the first FDA-approved treatment specifically for adults with moderate to severe CHE.
• The application is supported by Phase 3 DELTA 1 and DELTA 2 trial results, demonstrating significant efficacy and safety compared to a vehicle cream.
• If approved, delgocitinib cream promises to address the high unmet need for CHE patients, offering a new option beyond traditional topical corticosteroids.
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