相关临床试验
29
25 进行中
药物批准
51
批准总数
监管机构
3
监管机构数
成立时间
N/A
进行中（未招募）
23
79.3%
已完成
3
10.3%
尚未招募
2
6.9%
招募中
1
3.5%
- The Federal Circuit affirmed a ruling invalidating Wyeth's two patents on methods of treating resistant NSCLC with irreversible EGFR inhibitors for lack of enablement. - The court found the specification failed to teach how to determine a therapeutically effective, non-toxic "unit dosage," leaving skilled artisans to undue experimentation. - Trial evidence showed disclosed dosage ranges for exemplary compounds exceeded maximum tolerated doses in humans, with one by a factor of five. - The decision overturns a prior $107.5 million jury verdict in Wyeth's favor against AstraZeneca over its drug Tagrisso (osimertinib).
- Dr. Reddy's Laboratories announced the first-to-market launch of generic Bosutinib Tablets 400mg in the United States on June 13, 2026. - The product is a generic equivalent of Pfizer subsidiary Wyeth's Bosulif and was a first-to-file product eligible for 180 days of generic drug exclusivity. - The Bosulif brand (400mg) had U.S. sales of approximately $253.8 million for the 12-month period ended April 2026, per IQVIA data. - Dr. Reddy's collaborated with MSN Laboratories, which handled development and manufacturing, while Dr. Reddy's holds exclusive U.S. marketing rights.
- Heidelberg Pharma's supervisory board has appointed Dr. Dongzhou Jeffery Liu as Chairman of the Executive Board and CEO, effective December 24, 2025, replacing Prof. Dr. Andreas Pahl. - Dr. Liu brings over 25 years of pharmaceutical industry experience, currently serving as Chief Scientific Officer at Huadong Medicine and President of Huadong Global Development in China. - The leadership change occurs as the company advances its ATAC technology platform, with lead candidate HDP-101 in clinical development for multiple myeloma and having received FDA Orphan Drug and Fast Track designations. - Heidelberg Pharma specializes in developing antibody-drug conjugates using Amanitin from the death cap mushroom, representing a novel therapeutic approach in oncology.
- Iovance Biotherapeutics appointed Corleen Roche as Chief Financial Officer effective August 6, 2025, during the commercial launch of its groundbreaking TIL therapy. - Roche brings 30 years of biotech experience including CFO roles at CG Oncology, Immunome, and Biogen, with expertise in multiple product launches. - The appointment comes as Iovance commercializes Amtagvi, the first FDA-approved T cell therapy for solid tumors, marking a significant milestone in cancer treatment. - Roche will focus on revenue growth and pipeline investments as the company advances its tumor infiltrating lymphocyte platform across multiple solid tumor indications.
- Solu Therapeutics has appointed Enda Moran, PhD, MBA as Chief Operating Officer to lead operational functions as the company advances its Phase 1 clinical trial of STX-0712. - Dr. Moran brings over three decades of biomanufacturing experience from Pfizer, GSK, and other major pharmaceutical companies to support Solu's CyTAC and TicTAC platforms. - The appointment comes as Solu progresses STX-0712 through Phase 1 development for resistant/refractory chronic myelomonocytic leukemia and other hematologic malignancies. - Dr. Moran will oversee chemistry manufacturing and controls, quality, program management, and infrastructure development to support multiple clinical and regulatory milestones.
- Vima Therapeutics launched with $60 million Series A funding led by Atlas Venture to advance VIM0423, a potential first-in-class oral therapy for dystonia targeting muscarinic cholinergic receptors. - The company's lead candidate addresses an unmet medical need for over 100,000 Americans with isolated dystonia, as current treatments fail to target the underlying cause of the condition. - VIM0423 is currently in Phase 1 clinical trials with Phase 2 studies planned for the fourth quarter of 2025, representing a novel approach to movement disorder treatment. - The therapy aims to overcome limitations of existing muscarinic receptor drugs by providing improved pharmacology, efficacy, and safety profiles for patients with this disabling neurological condition.
- SK Bioscience has successfully won an appeal against Pfizer's subsidiary Wyeth LLC in a patent dispute over pneumococcal vaccine components exported to Russia for research purposes. - The Patent Court of Korea ruled that SK Bioscience's export of 13-valent pneumococcal conjugate vaccine raw materials did not violate a previous settlement agreement that restricted domestic production until 2027. - This victory allows SK Bioscience to continue development of its 21-valent pneumonia vaccine and highlights growing concerns about patent litigation from global pharmaceutical companies against Korean biotech innovations.
- A comprehensive analysis of 157,244 patients receiving pneumococcal vaccines found that 81.84% of adverse events were non-serious, with the most common reactions being injection site erythema, swelling, and pain. - The study identified 929 significant safety signals across multiple pneumococcal vaccine formulations using four disproportionality analysis methods, with 77.11% of adverse events occurring within 30 days post-vaccination. - This first-of-its-kind pharmacovigilance study integrating safety data across all pneumococcal vaccines in the U.S. VAERS database provides evidence-based risk stratification to inform clinical vaccination strategies.
• WuXi PharmaTech has appointed several key executives to its Board of Directors, including Ying Han, Stewart Hen, and co-founder Ning Zhao, bringing valuable financial and pharmaceutical expertise to the company. • The strategic board appointments aim to enhance WuXi's business operations and financial systems as the company continues to expand its pharmaceutical R&D outsourcing services in China and the United States. • Co-founder Tao Lin has stepped down from his position on the board and as Vice President of Internal Operations, marking a significant leadership transition for the growing pharmaceutical services organization.
