Clinical Trials
2
2 active
Approvals
95
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
Active, not recruiting
2
100.0%
- Shawn Patrick O'Brien, former CEO of Mayne Pharma, has been honored by Marquis Who's Who for over 40 years of expertise in pharmaceuticals and biotechnology. - During his 17-year tenure at AstraZeneca, O'Brien led the relaunch of Seroquel, growing revenue from $110 million to $5.6 billion and overseeing eight blockbuster brand launches. - O'Brien has held five CEO roles across companies including Cipher Pharmaceuticals, Altherx, Profectus BioSciences, and Solstice Neurosciences, and currently chairs SFA Therapeutics. - The recognition highlights a career spanning supply chain management, commercialization, and product development with a focus on women's health and dermatology at Mayne Pharma.
- Sol-Gel Technologies has completed patient enrollment for its pivotal Phase 3 clinical trial of SGT-610, a topical hedgehog pathway inhibitor for preventing basal cell carcinomas in Gorlin syndrome patients. - SGT-610 could become the first approved therapy for preventing new BCC lesions in this rare genetic disorder, with the company targeting potential peak revenue exceeding $300 million annually. - The company's Phase 1b trial of SGT-210 for Darier disease continues despite recruitment challenges, with market potential estimated between $200-300 million. - Sol-Gel secured $16 million from selling U.S. rights to EPSOLAY and TWYNEO to Mayne Pharma, extending its cash runway into the first quarter of 2027.
- An FDA expert panel convened to reassess boxed warnings for menopausal hormone therapy, with multiple experts arguing that current labels overstate risks and are not supported by comprehensive scientific evidence. - Panel members presented data showing that vaginal estrogen products carry significantly different safety profiles than systemic hormone therapy, yet both carry identical boxed warnings due to class labeling regulations. - Experts highlighted critical gaps in medical education, noting that only 31.3% of U.S. residency programs have standardized menopause training, contributing to underutilization of beneficial therapies. - The panel emphasized that reanalysis of Women's Health Initiative data shows favorable outcomes for women aged 50-59 years, with estrogen alone linked to reduced breast cancer incidence and mortality over long-term follow-up.
- The FDA's Office of Prescription Drug Promotion has cited Mayne Pharma for making misleading safety claims about its oral contraceptive Nextstellis in promotional materials. - Regulatory officials found that Mayne's professional slide deck inappropriately suggested Nextstellis is safer than other estrogen-containing contraceptives and understated serious risks, including breast cancer. - Nextstellis, approved in 2021 with a boxed warning for cardiovascular risks, contains drospirenone and estetrol and is contraindicated in patients with history of breast cancer and thrombotic diseases.
• Sol-Gel Technologies has entered into a $16 million agreement with Mayne Pharma for the sale and exclusive license of U.S. rights to dermatology products EPSOLAY and TWYNEO, extending the company's cash runway into Q1 2027. • The transaction allows Sol-Gel to focus resources on its promising SGT-610 program for Gorlin syndrome, which has completed 80% patient recruitment for Phase III trials with top-line results expected in Q4 2026. • Based on recent market research, Sol-Gel estimates SGT-610's U.S. market potential between $400-500 million annually as the first potential preventative treatment for basal cell carcinomas in Gorlin syndrome patients.
- North Carolina has attracted 71 international life science companies from 20 countries, generating over $2.5 billion in investments and creating 17,000 jobs in the past five years. - Novo Nordisk leads the expansion with a historic $1.8 billion manufacturing facility in Clayton, representing the largest single manufacturing investment in North Carolina's history. - Major international companies including Aurobindo Pharma, Grifols, and FUJIFILM Diosynth have established or expanded operations, drawn by the state's research infrastructure, skilled workforce, and strategic location.
