相关临床试验
232
15 进行中
药物批准
179
批准总数
监管机构
5
监管机构数
成立时间
1992
进行中（未招募）
10
4.3%
已完成
199
85.8%
尚未招募
5
2.2%
招募中
2
0.9%
终止
11
4.7%
撤回
5
2.2%
- Charles River Laboratories announced that CEO James C. Foster will retire in May 2026 after a distinguished 50-year career, during which he transformed the company from a niche research models business to a global leader in preclinical drug development with approximately $4 billion in annual revenue. - The Board of Directors unanimously appointed Birgit Girshick, current Executive Vice President and COO, as the next CEO effective May 2026, following a comprehensive succession planning process designed to ensure continuity and strategic alignment. - Under Foster's leadership, Charles River completed over 50 acquisitions, achieved S&P 500 status in 2021, and worked on more than 80% of drugs approved by the FDA since 2017, with stock price appreciation exceeding 10% compound annual growth rate since its 2000 IPO. - The succession plan will separate the Chair and CEO roles for enhanced corporate governance, with Martin Mackay becoming independent Board Chair while Foster remains as a non-executive Director.
- Alembic Pharmaceuticals received final FDA approval for its generic version of Zylet ophthalmic suspension containing loteprednol etabonate and tobramycin for treating inflammatory eye conditions with bacterial infection risk. - The company was granted Competitive Generic Therapy designation, making it eligible for 180 days of market exclusivity upon commercialization of the product. - This approval brings Alembic's total ANDA approvals from the US FDA to 231, comprising 211 final approvals and 20 tentative approvals.
- Bausch & Lomb's prescription dry eye drug Miebo costs over $800 monthly in the U.S., while the identical drug EvoTears sells over-the-counter in Europe for approximately $20. - The company achieved $172 million in 2024 sales by securing FDA approval as a prescription medication rather than pursuing over-the-counter status like in Europe. - This pricing strategy exemplifies how pharmaceutical companies exploit regulatory loopholes, with U.S. drug prices averaging 2.5 times higher than other developed nations. - Proposed FDA reforms could require international over-the-counter drugs to be evaluated for U.S. OTC status before prescription approval, potentially closing this pricing gap.
- A 7-year postmarketing analysis of lifitegrast ophthalmic solution 5% (Xiidra) confirms its favorable safety profile with no new safety signals identified across nearly 800,000 patient treatment years. - Real-world assessment data presented at the 2025 ASCRS Annual Meeting shows approximately two-thirds of patients achieved near or complete symptom resolution after 1-3 months of lifitegrast treatment. - Lifitegrast demonstrates sustained efficacy for dry eye disease management, with particular utility in contact lens wearers and patients undergoing various ocular surgeries.
- MIEBO (perfluorohexyloctane ophthalmic solution) is FDA-approved for treating the signs and symptoms of dry eye disease (DED). - Clinical trials (GOBI and MOJAVE) involving 1,217 patients showed MIEBO significantly improved corneal smoothness and reduced eye dryness symptoms after 57 days. - The most common side effects reported in the trials were blurred vision and conjunctival redness, each affecting 1% to 3% of patients. - Subgroup analyses indicated MIEBO's efficacy and safety were consistent across different sex, race, and age groups.
