相关临床试验
92
52 进行中
药物批准
170
批准总数
监管机构
4
监管机构数
成立时间
N/A
进行中（未招募）
16
17.4%
已完成
29
31.5%
尚未招募
36
39.1%
招募中
7
7.6%
- Hetero launched its once-weekly semaglutide injection Truglyx in Kenya at a Nairobi symposium attended by more than 300 physicians focused on diabetes and obesity. - Novo Nordisk separately introduced Ozempic for type 2 diabetes and Wegovy for weight management in Kenya, citing a 142 percent rise in African diabetes prevalence over ten years. - Hetero said Truglyx demonstrated bioequivalence to the reference semaglutide product, with 24-week clinical data showing improved glycemic control and weight reduction. - Experts at both events called for integrated cardio-metabolic care, earlier intervention, and improved affordability and access to GLP-1 therapies in African health systems.
- 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.
- ELMED Life Sciences raised $2.7 million in Series A funding from NABVENTURES-managed AgriSURE Fund to advance probiotic and biological solutions across multiple health sectors. - The Hyderabad-based biotech company develops microbiome-based products for animal health, agriculture, aquaculture, and human health, currently exporting to over 18 countries. - Funding will support expanded manufacturing capacity in Hyderabad, strengthen R&D capabilities, and scale distribution in domestic tier 2-3 markets and international regions including Europe, Asia, and Latin America. - The company operates a B2B model, partnering with pharmaceutical companies like Alchem and Hetero for probiotic supplement formulation and supply while serving multinational clients including Aurobindo and Apex Laboratories.
- Indian pharmaceutical companies including Hetero Labs, Cipla, Annora Pharma, and Natco Pharma have successfully won bids to supply generic drugs to Chinese hospitals through the country's volume-based procurement process. - Hetero Drugs and Cipla secured contracts to supply one billion tablets of Dapagliflozin, a diabetes medication that dominates China's small molecule drug market with sales exceeding 8 billion RMB ($1.14 billion). - The breakthrough represents a significant opportunity for Indian firms to penetrate China's pharmaceutical market, traditionally dominated by multinational companies, despite pricing pressures and competition from cost-advantaged local manufacturers.
- The FDA issued a Form 483 to Hetero Labs following a September 2025 inspection that revealed an undisclosed warehouse storing APIs and intermediates for US markets with severe GMP violations. - Inspectors documented pest infestations including birds, lizards, and cats among API drums, along with bird droppings on containers and nests within warehouse structures. - The facility operated without quality oversight, standard operating procedures, or environmental controls, with expired materials commingled with fresh batches and no traceability systems. - The violations indicate potential breaches of 21 CFR Part 211 regulations and could lead to Warning Letters or import alerts affecting Hetero Labs' global supply operations.
- Nigeria has launched the Innovative Cancer Medicine Demonstration Project at National Hospital Abuja, marking the first time advanced cancer immunotherapy will be administered in a structured feasibility study in Sub-Saharan Africa. - The program provides free nivolumab treatment to 30 patients with metastatic colorectal cancer, with full costs estimated at over seven billion naira sponsored by international partners including Bristol Myers Squibb, Roche, and the Parker Institute for Cancer Immunotherapy. - The initiative represents a collaboration between the Federal Government, Clinton Health Access Initiative, and pharmaceutical partners to demonstrate that Nigeria has the infrastructure and expertise to safely deliver advanced cancer treatment. - Success of this feasibility study could pave the way for including immunotherapy in Nigeria's National Health Insurance scheme and establishing cost negotiations for broader access across Africa.
- Bill Gates and the Pan American Health Organization are exploring ways to make expensive weight-loss drugs like Wegovy and Mounjaro more accessible in lower-income countries where 70% of obese patients live. - The Gates Foundation is conducting early-stage research into weight-loss drugs for gestational diabetes and could potentially support clinical trials to test these medicines in different populations. - PAHO is developing recommendations for optimal drug use and plans to engage with Novo Nordisk, Eli Lilly, and generic manufacturers within weeks to discuss bulk purchasing strategies. - Generic versions of semaglutide will become available starting next year as patents expire in China and India, potentially enabling lower-cost alternatives.
- Catalyst Pharmaceuticals and SERB S.A. reached a settlement agreement with Lupin that prevents generic competition for FIRDAPSE (amifampridine) until February 25, 2035. - The settlement resolves patent litigation stemming from Lupin's attempt to market a generic version of the rare disease treatment before patent expiration. - Catalyst has now settled similar patent disputes with Teva Pharmaceuticals and Inventia Life Science, with ongoing litigation against Hetero remaining. - The agreement ensures continued market exclusivity for FIRDAPSE, a treatment for patients with rare and difficult-to-treat diseases, extending commercial protection by over a decade.
- Catalyst Pharmaceuticals and its licensor SERB S.A. reached a settlement agreement with Teva Pharmaceuticals that prevents Teva from marketing a generic version of Firdapse until February 25, 2035. - The settlement resolves patent litigation over Firdapse 10 mg tablets, which treats Lambert-Eaton myasthenic syndrome (LEMS), a rare neuromuscular disorder. - Patent disputes with remaining defendants Hetero and Lupin continue, while the agreement must undergo review by the Federal Trade Commission and Department of Justice. - The settlement strengthens Catalyst's market position for its flagship orphan drug, following previous regulatory challenges that established important precedents for orphan drug exclusivity.
- The Russian Direct Investment Fund (RDIF) and Hetero have agreed to produce over 100 million doses per year of the Sputnik V vaccine in India. - Production is slated to commence in early 2021, with the aim of providing an efficient solution during the COVID-19 pandemic. - Clinical trials for Sputnik V are ongoing in multiple countries, including Phase II-III trials in India, to assess its efficacy. - Interim clinical trial results indicate a 95% efficacy rate 42 days after the first dose, with the vaccine priced at under $10 for international markets.
