Saphnelo approved in the EU for the treatment of moderate to severe systemic lupus erythematosus – AstraZeneca

AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite receiving standard therapy. Saphnelo is the first biologic for SLE approved in Europe with an indication that is not restricted to patients with a high degree of disease activity. […]

Promising skin probiotic could be a way to reduce antibiotic treatments for acne

Acne on the face is often treated with topical antibiotics, which tend to be used for an extended period of time and contribute to the serious problem of antibiotic resistance. Scientists are investigating an alternative approach: using probiotics to alter the collection of bacteria and other microorganisms residing on the skin. Although the microbial ecosystem (or “microbiome”) on the skin […]

New comprehensive phase III data show first-in-class Tremfya provided durable improvements in measures of psoriatic arthritis through two years – Johnson & Johnson

The Janssen Pharmaceutical Companies of Johnson & Johnson announced comprehensive efficacy and safety data from the DISCOVER–2 trial of Tremfya (guselkumab) were published in Arthritis & Rheumatology, representing the final results of the first two-year clinical trial investigating a selective interleukin (IL)-23 inhibitor therapy in active psoriatic arthritis (PsA). Results show a majority of Tremfya-treated biologic-naïve adult patients with active […]

Possibility of vaccine to prevent skin cancer

Research by the Oregon State University College of Pharmacy suggests that a vaccine stimulating production of a protein critical to the skin’s antioxidant network could help people bolster their defenses against skin cancer. Ultraviolet radiation from the sun leads to oxidative stress, which increases the risk of skin cancers such as melanoma, explains Arup Indra, professor of pharmaceutical sciences at […]

Cibinqo recommended for approval by CHMP for atopic dermatitis – Pfizer

Pfizer announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the 100 mg and 200 mg doses of Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for marketing authorization to treat moderate to severe atopic dermatitis (AD) in adults who are candidates for systemic therapy. The […]

Phase III MIRROR trial of Krystexxa meets primary endpoint in chronic gout – Horizon Therapeutics

Horizon Therapeutics announced topline results of the phase III MIRROR trial met the primary endpoint, showing a significant increase in efficacy using Krystexxa (pegloticase injection) with the immunomodulator methotrexate as compared to the response rate of Krystexxa with placebo for people with chronic gout refractory to conventional therapies – also known as uncontrolled gout. Results were from the Methotrexate to […]

Janssen submits application seeking FDA approval of Stelara for the treatment of pediatric patients with juvenile psoriatic arthritis

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA seeking expanded approval of Stelara (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA). The filing is supported by extrapolation of data from nine studies across both adult trials in active PsA and […]

FDA approves Tavneos for vasculitis – ChemoCentryx

ChemoCentryx announced that the FDA has approved Tavneos (avacopan), an orally administered selective complement 5a receptor inhibitor, as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (also known as ANCA-associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA vasculitis), in combination with standard therapy. […]

FDA approves Opzelura cream for mild to moderate atopic dermatitis – Incyte

Incyte announced that the FDA has approved Opzelura (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Opzelura is the first and only topical formulation of a […]

UK MHRA grants marketing authorisation for Cibinqo for adults and adolescents with moderate to severe atopic dermatitis – Pfizer

Pfizer Inc. announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Great Britain marketing authorization for Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and over, who are candidates for systemic therapy. Abrocitinib is licensed in Great […]