Clinical Trials
3
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Completed
1
33.3%
Unknown
2
66.7%
No approval data available
- Taiwan's Food and Drug Administration has approved PharmaMar's Zepzelca (lurbinectedin) in combination with atezolizumab as first-line maintenance treatment for adult patients with advanced small cell lung cancer. - The approval allows administration following initial induction therapy to patients who achieve disease stabilization or improvement, joining nine other countries that have authorized this combination for the same indication. - Small cell lung cancer represents approximately 15% of lung cancer cases and is characterized by aggressive behavior with rapid growth and early tendency to spread. - Lurbinectedin monotherapy is already approved as second-line treatment in 22 countries for patients whose disease progresses during or after platinum-based chemotherapy.
- Alvotech founder Róbert Wessman will transition from CEO to Executive Chairman at the end of Q1 2026, continuing in a full-time capacity focused on strategy and business development. - Lisa Graver, former CEO of Alvogen and current Alvotech board member, has been appointed as the new Chief Executive Officer following a planned succession process. - The leadership transition comes as Alvotech operates with five biosimilars on the global market and maintains a pipeline of 30 products in development targeting autoimmune disorders, cancer, and other therapeutic areas. - Graver brings over 25 years of pharmaceutical leadership experience and has worked closely with Wessman for more than two decades across specialized generics and biosimilar sectors.
- Lotus Pharmaceutical has submitted a New Drug Application to South Korea's Ministry of Food and Drug Safety for VIZZ, marking the first regulatory submission under its partnership with LENZ Therapeutics. - The application is supported by positive Phase III CLARITY trial data showing VIZZ improved near vision within 30 minutes and maintained effects for up to 10 hours in presbyopia patients. - LENZ Therapeutics stands to receive up to $125 million in milestone payments and double-digit royalties from the partnership covering South Korea and Southeast Asian markets. - VIZZ represents a preservative-free, once-daily eye drop containing aceclidine that could provide a life-changing treatment option for millions affected by age-related presbyopia.
- Lotus Pharmaceutical has submitted a New Drug Application to South Korea's Ministry of Food and Drug Safety for VIZZ, marking the second regulatory submission for the presbyopia treatment in Asia. - The submission is supported by positive Phase 3 CLARITY trial data showing VIZZ achieved all primary and secondary endpoints, improving near vision within 30 minutes for up to 10 hours. - Under the licensing agreement, LENZ is eligible for up to $125 million in milestone payments and double-digit royalties, while Lotus gains exclusive rights across South Korea and Southeast Asia. - VIZZ represents the first FDA-approved aceclidine-based eye drop for presbyopia, a condition affecting an estimated 1.8 billion people globally and 128 million in the United States.
- LENZ Therapeutics has partnered with Lotus Pharmaceutical in a deal worth up to $125 million plus double-digit royalties to commercialize LNZ100, an aceclidine-based eye drop for presbyopia, in Korea and Southeast Asia. - The FDA has accepted LNZ100's New Drug Application with a target action date of August 8, 2025, potentially offering a novel treatment option for a condition affecting an estimated 1.8 billion people globally. - Lotus Pharmaceutical will leverage its regional commercial infrastructure to bring LNZ100 to more than 100 million presbyopia patients across Southeast Asia, pending regulatory approvals.
- Teva Pharmaceuticals secured semi-exclusive commercialization rights for FYB203 (AHZANTIVE), Formycon's aflibercept biosimilar, across major European markets and Israel following FDA approval in June 2024. - Lotus Pharmaceutical obtained exclusive licensing rights for the same biosimilar in eight Asia-Pacific countries, expanding access to this treatment for severe retinal diseases. - The partnerships leverage existing commercial infrastructure and distribution networks, with Eylea achieving global sales of approximately $9 billion in 2023, including $2.9 billion in Europe. - European Commission approval for FYB203 was granted in January 2025, while regulatory submissions for Asia-Pacific markets are being prepared according to local requirements.
