相关临床试验
23
21 进行中
药物批准
28
批准总数
监管机构
1
监管机构数
成立时间
1989
进行中（未招募）
21
91.3%
已完成
1
4.3%
招募中
1
4.3%
- Edgewise Therapeutics appointed Christopher Martin, former Chief Commercial Officer of Verona Pharma, to its Board of Directors to support upcoming commercial launches. - Martin brings extensive experience in product launches, having led commercial strategies for multiple biotech companies including Verona Pharma's Ohtuvayre and SK Life Science's XCOPRI. - The appointment comes as Edgewise prepares for its first commercial launch of sevasemten in Becker muscular dystrophy and advances its cardiovascular asset EDG-7500 to Phase 3 trials. - Edgewise's pipeline includes three novel therapeutics targeting muscle diseases: sevasemten for muscular dystrophies, EDG-7500 for hypertrophic cardiomyopathy, and EDG-15400 for heart failure.
- Multiple high-profile ANDA litigation settlements were resolved in the second and third quarters of 2025, involving major pharmaceutical companies and generic manufacturers across diverse therapeutic areas. - Settlement agreements typically resulted in patent validity acknowledgments and injunctions against generic manufacturers, with most claims dismissed without prejudice while allowing FDA approval processes to continue. - Notable settlements included complex multi-patent disputes for blockbuster drugs like Rinvoq, Jardiance, Xifaxan, and Biktarvy, demonstrating the ongoing importance of patent protection strategies in pharmaceutical innovation.
- Bausch Health announced the acquisition of DURECT Corporation for $63 million upfront, with potential milestone payments up to $350 million, to gain access to larsucosterol, an epigenetic modulator with FDA Breakthrough Therapy Designation for alcoholic hepatitis. - Larsucosterol represents a potential first-in-class treatment for alcoholic hepatitis, a life-threatening condition responsible for approximately 100 deaths per day in the US and 164,000 hospital admissions in 2021, with no currently approved therapies. - The acquisition strengthens Bausch Health's hepatology portfolio alongside their ongoing Phase 3 rifaximin SSD program, with a registrational Phase 3 trial for larsucosterol planned to evaluate 90-day survival in severe alcoholic hepatitis patients.
- A federal judge dismissed a seven-year False Claims Act lawsuit against Valeant Pharmaceuticals and Salix Pharmaceuticals alleging fraudulent patent practices for ulcerative colitis drug Apriso. - Whistleblower Zachary Silbersher claimed the companies fraudulently obtained patents, excluded generic competitors, and overbilled Medicare for prescriptions. - The dismissal was without prejudice, allowing the plaintiff to amend and refile claims with more specific allegations against each defendant.
- Tharimmune announced key leadership changes with Sireesh Appajosyula becoming CEO and Vincent LoPriore appointed Executive Chairman in June 2025. - The company added James Gordon Liddy, a retired Navy SEAL Commander with national security expertise, to its board of directors to support TH104 development. - TH104 is a buccal film formulation designed to deliver opioid antagonist therapy for military personnel and first responders exposed to weaponized fentanyl and high-potency opioids. - The leadership appointments strengthen Tharimmune's strategic position as it advances its lead candidate through the 505(b)2 regulatory pathway for respiratory and nervous system depression prevention.
- Komodo Health's healthcare intelligence platform enabled 31 research studies presented at the 2025 ISPOR global conference, including three studies led by Komodo researchers and 27 collaborative studies with academic institutions and Life Sciences companies. - The research spans multiple therapeutic areas including oncology, cardiovascular disease, metabolic disorders, neurology, and rare diseases, demonstrating the platform's versatility in addressing critical evidence gaps. - The platform provides a multidimensional view of 330+ million patient journeys by linking de-identified claims data with specialty datasets, enabling researchers to generate evidence faster and more accurately. - Studies include analysis of opioid-induced constipation economic burden, cardiovascular risk prediction, MASH diagnostic approaches, narcolepsy healthcare costs, and Fabry disease resource utilization patterns.
• Several companies are actively developing novel therapies for hepatic encephalopathy (HE), a neuropsychiatric condition resulting from advanced liver dysfunction. • Key players like Salix Pharmaceuticals and Vedanta Biosciences are advancing treatments such as Xifaxan and VE-303, showing promise in clinical trials. • Emerging therapies focus on innovative mechanisms like gut microbiota modulation and ammonia-lowering agents to improve patient outcomes. • Clinical trials are assessing various routes of administration and molecule types to address the unmet needs in HE treatment.
• Bausch Health's RED-C program investigates a novel rifaximin formulation (SSD-40IR) for delaying the onset of first overt hepatic encephalopathy (OHE) hospitalization in cirrhosis patients. • The Phase 3 trials are randomized, double-blind, and placebo-controlled, enrolling adults with cirrhosis and medically controlled ascites but no prior OHE history. • Topline data from the RED-C trials, which have completed enrollment across 398 sites in 17 countries, are anticipated in the first half of 2026. • Rifaximin SSD-40IR aims to enhance gastrointestinal solubility and minimize systemic exposure, potentially improving OHE prevention compared to existing treatments.
• A post-hoc analysis revealed that rifaximin monotherapy significantly reduced overt hepatic encephalopathy (OHE) recurrence compared to lactulose monotherapy over 6 months. • Rifaximin demonstrated a longer time to breakthrough OHE episodes and significantly lower all-cause mortality compared to lactulose in patients with cirrhosis. • The study highlights rifaximin as a potential preferred option for secondary prophylaxis of OHE, especially for patients with lactulose intolerance or adherence issues. • Despite the higher cost of rifaximin, its effectiveness in reducing hospital readmissions and improving patient outcomes may offset the initial expense.
• Analysis of two randomized trials reveals that Xifaxan monotherapy is more effective than lactulose in reducing overt hepatic encephalopathy (OHE) recurrence and mortality. • New data highlights Xifaxan's impact on reducing rehospitalizations for OHE in both commercially insured and Medicare patient populations. • Plenvu's efficacy as a bowel preparation medication is confirmed in colonoscopy patients with comorbid conditions or those on medications affecting bowel prep quality.
