相关临床试验
124
44 进行中
药物批准
236
批准总数
监管机构
4
监管机构数
成立时间
N/A
已完成
55
44.4%
尚未招募
44
35.5%
招募中
16
12.9%
暂停
2
1.6%
Unknown
6
4.8%
- The EPO Boards of Appeal revoked EP 3 288 980, a BMS patent covering anti-PD-1 treatment of PD-L1-positive melanoma, in decision T 0715/24. - The Board ruled that combining a flat-dose regimen with nivolumab monotherapy extended beyond the content of the application as filed. - BMS also lost EP 3 322 731 after withdrawing its appeal, while the basic patent EP 2 161 336 remains protected by SPCs and data exclusivity until end of 2030. - Amgen's nivolumab biosimilar ABP 206 is in phase 3, with Sandoz, Intas and Accord also developing Opdivo biosimilars.
- The Delhi High Court granted an ex-parte ad-interim injunction restraining Intas Pharmaceuticals from launching generic Dabrafenib based on Novartis's patent IN'655, valid until 2029. - The court relied on an RTI reply from Gujarat's drug regulator and a private investigation report showing Intas had obtained manufacturing approval and was preparing exhibit batches. - In a separate ruling, the same court barred Torrent Pharmaceuticals from launching Dabrafenib products after Torrent gave an undertaking not to manufacture until patent expiry. - Both rulings preserved the defendants' rights under Section 107A (Bolar exemption) for research and regulatory purposes while blocking commercial launch.
- Indian pharmaceutical companies are requesting a 50% price increase for essential platinum-based cancer drugs including carboplatin, cisplatin, and oxaliplatin due to manufacturing becoming commercially unviable. - Platinum prices have nearly doubled from ₹3,869 per gram in September to ₹8,000 per gram in February, driven by geopolitical uncertainty affecting precious metals markets. - Major manufacturers including Cipla, Dr Reddy's, and Zydus warn that without government intervention, the availability of these first-line cancer treatments may be threatened. - The platinum-based drug market in India is valued at ₹110 crore with 14% annual growth, but actual market size could be ten times higher when including institutional sales.
- The CHMP has issued a positive opinion for serplulimab (HETRONIFLY®), recommending its approval in Europe for ES-SCLC treatment. - Serplulimab, developed by Henlius and to be commercialized by Intas, is a recombinant humanized anti-PD-1 monoclonal antibody. - The recommendation is based on the ASTRUM-005 trial, which showed serplulimab plus chemotherapy improved outcomes in ES-SCLC. - If approved, serplulimab will be the first anti-PD-1 monoclonal antibody available in Europe for first-line treatment of ES-SCLC.
