相关临床试验
23
4 进行中
药物批准
11
批准总数
监管机构
2
监管机构数
成立时间
N/A
已完成
15
65.2%
尚未招募
4
17.4%
招募中
2
8.7%
- India's Subject Expert Committee recommended waiving local Phase III and bioequivalence trials for generic lenacapavir PrEP from Dr. Reddy's and Emcure Pharmaceuticals. - The waiver applies only to the HIV prevention (PrEP) indication, not to treatment of multidrug-resistant HIV-1, which requires additional pharmacokinetic and ethnicity data. - Marketing authorization would be conditional on mandatory post-marketing Phase IV efficacy studies, with protocols due to CDSCO within three months. - Lenacapavir, a first-in-class long-acting capsid inhibitor, showed zero infections in PURPOSE 1 and a 96% incidence reduction in PURPOSE 2.
- 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.
