相关临床试验
55
3 进行中
药物批准
108
批准总数
监管机构
4
监管机构数
成立时间
N/A
已完成
42
76.4%
尚未招募
3
5.5%
招募中
10
18.2%
- The Bombay High Court questioned the Maharashtra FDA's cancellation of Cipla Pharma & Life Sciences' wholesale drug-sale licences, describing the action as "high-handed." - The FDA withdrew the cancellation order and agreed to issue a fresh notice after Cipla argued it had not received an adequate opportunity to be heard. - The dispute stems from alleged irregularities involving Reactin Plus tablets, including packaging claims, stock-record discrepancies, and non-compliance with recall directions. - The court advised the regulator to avoid scheduling hearings on public holidays, underscoring broader concerns about due process in FDA enforcement actions.
- The Madras High Court dismissed a writ petition by E.R. Squibb & Sons LLC and Ono Pharmaceuticals challenging a Patent Opposition Board recommendation against their PD-1 cancer immunotherapy patent, ruling that such recommendations are intermediate steps not subject to judicial review before final orders. - The Bombay High Court set aside a Controller's order in a curcumin pharmaceutical patent opposition case, emphasizing that patent authorities must provide reasoned decisions rather than bare conclusions when adjudicating post-grant oppositions. - Both rulings reinforce the statutory framework of India's patent opposition system, with the Madras court preventing premature judicial intervention while the Bombay court ensuring proper application of mind by patent authorities.
- Algorae Pharmaceuticals has partnered with Indian pharmaceutical company Cadila to commercialize two generic medicines for cardiovascular and metabolic disorders in Australia and New Zealand markets. - The partnership establishes a multi-partner commercial platform spanning oncology, cardiovascular, and metabolic diseases, complementing existing agreements with Sakar Healthcare and Dr Reddy's Laboratories. - Algorae's AlgoraeOS Version 2 drug-combination prediction platform has been validated with approximately 10,000 data points across 84 cannabidiol-drug-cell line combinations at Peter MacCallum Cancer Centre.
- Algorae Pharmaceuticals has secured two major licensing agreements to launch seven generic medicines in Australia and New Zealand, targeting cardiovascular, metabolic, and oncology therapeutic areas. - The company partnered with Cadila Pharmaceuticals for two cardiovascular and metabolic disorder treatments, and with Sakar Healthcare for five oncology medicines targeting a combined market valued at approximately $10 million annually. - These commercial partnerships complement Algorae's ongoing AI-driven drug discovery validation trial at Peter MacCallum Cancer Centre, which is evaluating 21 oncology drug targets generated by the AlgoraeOS platform. - The agreements position Algorae to diversify its revenue base while building on its proprietary AI-enabled pharmaceutical development platform for future innovation programs.
- Cadila Pharmaceuticals has launched Biscado (Bisoprolol), a highly cardioselective beta-1 adrenergic blocker, marking its entry into the beta-blocker therapy segment for cardiovascular disease management. - The launch is particularly significant for India, where individuals are predisposed to higher sympathetic activity and elevated resting heart rates, with studies showing a 10 beats per minute increase in resting heart rate associated with a 20% increase in cardiovascular death risk. - Clinical evidence from the landmark CIBIS-II study demonstrates Biscado's efficacy with a 34% reduction in all-cause mortality, 44% reduction in sudden cardiac death, and 36% reduction in heart failure hospitalizations. - The drug will be available in both monotherapy and fixed-dose combinations with other antihypertensive agents, providing comprehensive cardiovascular management options for physicians.
