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Mumbai: The United States Food and Drug Administration (U.S. FDA) has granted Glenmark Pharmaceuticals Inc., USA tentative approval for Calcipotriene and Betamethasone Dipropionate Foam, 0.005 per cent and 0.064 per cent, the generic version of Enstilar®1 Foam, 0.005 per cent and 0.064 per cent, by Leo Pharma AS.
Enforcement Report - Week of September 22, 2021
CHARLESTON, S.C. and COPENHAGEN, Denmark, July 19, 2021 /PRNewswire/ -- EPI Health and MC2 Therapeutics, announced today commercial availability in the United States of Wynzora® Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for the topical treatment of plaque psoriasis in adults, 18 years of age or older.
Two posters featuring highly significant head to head data for Wynzora® Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) vs Taclonex® Topical Suspension were shown at the Maui Derm NPPA Summer meeting from 23 to 26 June 2021.
BARCELONA, Spain and COPENHAGEN, Denmark, July 6, 2021 /PRNewswire/ -- Almirall S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, and MC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard within topical therapies for autoimmune and chronic inflammatory conditions, announced today the successful completion of a decentralized procedure in Europe for a topical treatment option (50 µg/g calcipotriol and 0.5 mg/g betamethasone as dipropionate) of mild to moderate psoriasis vulgaris in adults, including scalp psoriasis.
MC2 Therapeutics, a commercial stage pharmaceutical company focused on topical therapies for chronic inflammatory conditions, today announced the submission of its Marketing Authorization Application (MAA) in EU for Wynzora® Cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone (as dipropionate)) for the treatment of plaque psoriasis. The European filing follows the submission of a New Drug Application on Wynzora® Cream to the U.S. Food and Drug Administration (FDA) in September 2019.
Swedish firm Lipidor AB has announced an agreement with Cadila Pharmaceuticals, a leading Indian pharmaceutical company with extensive CRO capacity, to conduct a Phase III study for Lipidor's drug candidate AKP-02. The study is expected to commence in Q1 2021 with final reporting in Q1 2022.