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Breaking News: Japan First in the World to Approve Dupilumab for CSU

The Dermatology Digest

The Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for dupilumab (Dupixent, Sanofi and Regeneron Pharmaceuticals, Inc.) and Novartis Pharmaceuticals). Japan is the first country to approve dupilumab for CSU. This study met the primary and all key secondary endpoints.

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Biosimilar News: Stada, Alvotech Launch the First Ustekinumab Biosimilar Across Europe

The Dermatology Digest

Launching Uzpruvo at the earliest opportunity in Europe’s largest pharmaceutical markets, promotes access by creating competition,” says STADA CEO Peter Goldschmidt in a news release. We are delighted at the launch of Uzpruvo in Europe and to be first-to-market,” adds Robert Wessman, Chief Executive Officer of Alvotech.

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Biosimilar News: FDA Approves Simlandi as Third Interchangeable Humira Biosimilar

The Dermatology Digest

While both low-concentration and high-concentration strength biosimilars of Humira are marketed in the U.S. We strongly believe that biosimilars are important in addressing inflationary pressures in the healthcare system across all markets, especially in the U.S. where biologics represent well over 40% of all pharmaceutical spending.

Safety 36
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Biosimilar Watch: FDA Accepts BLA for Proposed Stelara Biosimilar 

The Dermatology Digest

The clinical results demonstrated that DMB-3115 and its reference product, ustekinumab, are highly similar, and have no clinically meaningful differences in terms of quality, safety and efficacy. As a global subsidiary of Intas Pharmaceuticals, Accord BioPharma will be responsible for U.S. market during the next five years.

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Oh, The Places Dermatology Will Go in 2024!

The Dermatology Digest

Jashin Wu, MD, founder and CEO of the Dermatology Research and Education Foundation in San Diego, CA, says that more psoriasis patients will see improvements in their condition due to the influx of new agents and biosimilars on the market. Dupilumab (Dupixent, Regeneron Pharmaceuticals, Inc.,

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TDD Industry News and Views: Weekly Updates on Comings, Goings, and Other Happenings in Dermatology

The Dermatology Digest

Verrica Pharmaceuticals Files Lawsuit Against Canadian Drug Manufacturer for False Advertising, Unfair Competition Verrica Pharmaceuticals Inc. a Canada corporation requesting that the court enjoin Dormer Labs from marketing, selling, and distributing drugs containing cantharidin in the United States.

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High Levels of Benzene Found in Prescription and OTC Benzoyl Peroxide Acne Products 

The Dermatology Digest

Benzoyl Peroxide-based acne medications can become unstable and form benzene, a known human carcinogen, according to new research from Valisure, an independent laboratory focused on testing the purity and safety of pharmaceutical drugs and consumer products. Food and Drug Administration (FDA).