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Evolus Scores EU Approval of Estyme Injectable Hyaluronic Acid Gel Fillers Under New Medical Device Regulation Process

The Dermatology Digest

The EU Medical Device Regulation (MDR) certification gave its nod to four injectable hyaluronic acid (HA) gel fillers from Evolus under the brand name Estyme, The CE Mark certification, through the new MDR process, represents more stringent requirements, designed to ensure the safety, efficacy, and quality of medical devices sold in Europe.

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PDUFA Delay: FDA Asks for More Information From Abeona for Pz-cel Market Application

The Dermatology Digest

The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support the approval of pz-cel. The BLA for pz-cel was accepted for filing and granted priority review designation by the FDA in November 2023.

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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. “The approval of SIMLANDI marks the first high-concentration, citrate-free biosimilar to Humira with IC status,” says Dr. Eric Hughes, Executive Vice President Global R&D and Chief Medical Officer at Teva, in a news release.

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PHysicians & the esthetician

Southeastern Esthetics Institute

Having a thorough understanding of the dermatology and plastic surgery procedures, in addition to all new and modern cosmetic procedures on the market, is critical in assisting your clients in answering questions. A complete system must be in place per office, for the role of every action within the practice.

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MoonLake Immunotherapeutics Receives Regulatory Greenlights for Phase 3 Program of Sonelokimab in PsA

The Dermatology Digest

Marketing Authorization Application. Two global, randomized, double blind, placebo-controlled trials are planned (IZAR-1 and IZAR-2) to evaluate the efficacy and safety of the nanobody sonelokimab over one year.

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HS Pipeline Watch: MoonLake Immunotherapeutics’ Sonelokimab Heads to Phase 3

The Dermatology Digest

Marketing Authorization Application. About the MIRA trial The MIRA trial (M1095-HS-201) is a global, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of the Nanobody sonelokimab, administered subcutaneously, in the treatment of adult patients with active moderate-to-severe hidradenitis suppurativa.

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