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Elanco Receives USDA Approval for Befrena™ (tirnovetmab), a New Anti-IL31 Monoclonal Antibody Injection Targeting Canine Allergic and Atopic Dermatitis
Prnewswire· 2025-12-31 19:00
Core Insights - Elanco Animal Health has received USDA approval for Befrena (tirnovetmab), a new monoclonal antibody injection targeting canine allergic and atopic dermatitis, with a dosing interval of 6 to 8 weeks, which is longer than the competitor lokivetmab's 4 to 8 weeks [1][2][4] - The approval of Befrena is part of Elanco's strategy to enhance its leadership in canine dermatology and monoclonal antibodies, marking its second dermatology product approval in less than 18 months [2][4] - Elanco plans to launch Befrena in the first half of 2026, further expanding its product offerings in the $1.3 billion U.S. canine dermatology market [2][4] Company Developments - Elanco's commitment to innovation is highlighted by the launch of the America's Itchy Dogs Report, which reveals that 90% of dogs in the U.S. experience itchiness, leading to significant spending on over-the-counter remedies by pet owners [3] - The company has also improved the labeling of its existing product Zenrelia, a once-daily oral JAK inhibitor for skin allergies, following FDA review [2][3] Industry Context - The animal health sector is increasingly focusing on antibody-based therapies, with a significant demand for effective itch relief options among veterinarians [3][4] - Nearly 98% of veterinarians treat dogs for atopic dermatitis, indicating a widespread concern and a substantial market opportunity for new treatments like Befrena [4]
Adagene Appoints John Maraganore, Ph.D. as Executive Advisor
Globenewswire· 2025-04-28 12:00
Core Insights - Adagene Inc. has appointed Dr. John Maraganore as Executive Advisor to provide strategic guidance and mentorship to the company's leadership team [1][2] Company Overview - Adagene Inc. is a clinical-stage biotechnology company focused on developing novel antibody-based cancer immunotherapies, utilizing computational biology and artificial intelligence [4] - The company has established strategic collaborations with global partners to leverage its SAFEbody precision masking technology [4] Technology and Innovation - Adagene's proprietary Dynamic Precision Library (DPL) platform includes NEObody™, SAFEbody®, and POWERbody™ technologies, aimed at addressing safety and tolerability challenges in antibody therapeutics [5] - The SAFEbody technology allows for tumor-specific targeting of antibodies while minimizing on-target off-tumor toxicity in healthy tissues [5] Clinical Development - Adagene's lead clinical program, ADG126 (muzastotug), is a masked anti-CTLA-4 SAFEbody currently in phase 1b/2 clinical studies, particularly targeting Metastatic Microsatellite-stable Colorectal Cancer [6] - The SAFEbody platform is validated for application across various antibody-based therapeutic modalities, including Fc empowered antibodies and antibody-drug conjugates [6] Leadership and Expertise - Dr. John Maraganore previously served as CEO of Alnylam, where he led the company through the approval and commercialization of four RNA interference therapeutic medicines, creating over $25 billion in market capitalization [2][3] - He has extensive experience advising and mentoring life sciences CEOs and sits on the boards of public and private companies [3]