If a recent warning letter is anything to go by, the U.S. FDA could be using the 2013 Drug Supply Chain Security Act as another enforcement tool to shut down unauthorized suppliers by clamping down on the dispensers that purchase their unapproved drug products.
Abbvie Inc. is buying exclusive rights to develop, manufacture and commercialize two Nav1.8 inhibitors for pain – HSK-55718 and HSK-51155 – from Haisco Pharmaceutical Group Co. Ltd. for $30 million up front and up to $715 million in milestone payments, plus royalties.
Pemphigus vulgaris (PV) is a life-threatening autoimmune disease affecting the skin, causing painful erosions on the skin and mucous membranes. PV is caused by IgG4 autoantibodies that target desmoglein 1 (DSG1) and DSG3, which are involved in keratinocyte cell-cell adhesion. There is a high unmet medical need for PV, since current therapies rely on systemic corticosteroids and immunosuppressants.
Researchers from Singlomics Zhuhai Danxu Biopharmaceuticals Co. Ltd. presented DXP-006, a humanized antibody targeting IL1RAP, a shared co-receptor required for IL-1, IL-33 and IL-36 cytokines.
Werner syndrome results from biallelic mutations in the WRN gene on chromosome 8, leading to accelerated aging symptoms. Researchers at Sumitomo Pharma Co. Ltd. have reported the development and characterization of WRN-108, a splice-switching antisense oligonucleotide (ASO) designed to induce exon 27 skipping in WRN transcripts carrying the c.3139-1G>C mutation.
Atopic dermatitis (AD) is a chronic inflammatory skin disorder associated with increased oxidative stress. In this context, pharmacological activation of the Keap1-Nrf2 pathway, a key regulator of antioxidant and cytoprotective gene expression, has emerged as a promising therapeutic strategy to re-establish redox homeostasis and reduce inflammation in AD. Researchers from the Korea Institute of Science and Technology reported the design and preclinical characterization of a novel Nrf2 activator in models of AD.
Simcere Pharmaceutical Group Ltd.’s monoclonal antibody, rademikibart (CBP-201), met the primary endpoint in a Chinese phase III study in adults and adolescents with moderate to severe atopic dermatitis.
Infinimmune Inc. has recently presented results at the annual American Academy of Dermatology conference regarding their anti-IL-22 antibody IFX-101 for the treatment of atopic dermatitis.
Dysregulated type 2 immune responses are central in atopic dermatitis (AD) pathophysiology. Key cytokine IL-13 drives epidermal barrier dysfunction and inflammation, while IL-31 mediates pruritus via activation of sensory neurons. Both represent clinically validated, complementary targets addressing both inflammation and itch in AD.
Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease characterized by dysregulated T-cell-mediated immune responses and suboptimal outcomes with current therapies. Increased expression of OX40 and OX40L in lesional HS skin suggests a contributory role for this pathway in disease-associated inflammation.
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