相关临床试验
454
20 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1888
进行中（未招募）
14
3.1%
Approved For Marketing
3
0.7%
已完成
373
82.2%
尚未招募
6
1.3%
招募中
12
2.6%
暂停
2
0.4%
终止
30
6.6%
Unknown
3
0.7%
撤回
11
2.4%
暂无批准数据
- Crystalys Therapeutics has appointed Tim Walbert, former CEO of Horizon Therapeutics, as an independent board director to provide commercial leadership expertise. - Walbert brings significant experience in gout therapeutics and led Horizon's transformation into a rare disease leader before its $28 billion acquisition by Amgen. - The appointment comes as Crystalys advances dotinurad, a next-generation URAT1 inhibitor, through global Phase 3 registration trials for gout treatment. - Dotinurad aims to address a critical treatment gap as a second-line therapy between first-line xanthine oxidase inhibitors and last-line uricase therapy.
- Abbott's CardioMEMS HERO device has received FDA approval as a next-generation pulmonary artery pressure reader for heart failure patients, featuring a 60% lighter design compared to its predecessor. - The HERO reader works with Abbott's implanted CardioMEMS PA sensor to enable daily remote monitoring of pulmonary artery pressures, allowing clinicians to detect worsening heart failure before symptoms appear. - Clinical trials demonstrate the CardioMEMS HF System reduces heart failure hospitalizations by 57% and has been approved for routine NHS use in England after showing 34% reduction in hospital admissions. - The device represents a significant advancement in remote patient monitoring, with integrated Wi-Fi and cellular connectivity enabling patients to take readings virtually anywhere with signal coverage.
- Medtronic announced FDA 510(k) clearance for its MiniMed Go Smart Multiple Daily Injection system, integrating the InPen smart insulin pen with Abbott's Instinct sensor through a unified app. - The system addresses the needs of over 15 million people worldwide who rely on multiple daily injections, providing missed dose alerts, dose calculations, and actionable guidance to reduce diabetes management burden. - Real-world data from the previous generation system showed Time in Range increased from 55.7% to 67.2% when users addressed more than 75% of missed dose alerts within an hour. - The system is cleared for individuals with insulin-requiring type 1 and type 2 diabetes aged 7 years and older, with commercial launch expected in the U.S. this spring.
- The FDA has approved Edwards Lifesciences' Sapien M3 system as the first fully percutaneous transseptal transcatheter mitral valve replacement device for patients with moderate-to-severe mitral regurgitation who are ineligible for surgery or transcatheter edge-to-edge repair. - The approval is based on results from the 299-patient ENCIRCLE trial, which demonstrated a 25.2% rate of all-cause death or hospitalization for heart failure at one year, significantly lower than the predetermined performance goal. - Sapien M3 is also approved for treating symptomatic mitral valve dysfunction associated with mitral annular calcification in patients unsuitable for surgery or TEER as assessed by a multidisciplinary heart team. - The device uses a two-step procedure involving delivery of a dock followed by valve deployment to completely replace the mitral valve, potentially extending treatment options to previously unaddressed patient populations.
- Abbott has received FDA clearance and CE Mark for its Amplatzer Piccolo Delivery System, designed specifically to treat patent ductus arteriosus (PDA) in premature infants weighing as little as two pounds. - The new delivery system simplifies PDA closure procedures by requiring only one catheter instead of multiple, with a shorter and softer design that enables more precise device positioning in tiny babies. - Patent ductus arteriosus affects approximately 20% of premature infants and involves a life-threatening opening between blood vessels in the heart that fails to close after birth. - The system works with Abbott's Amplatzer Piccolo Occluder, the world's first and only minimally invasive transcatheter treatment approved for PDA closure in premature infants.
- Spruce Biosciences appointed Keli Walbert, a veteran pharmaceutical commercial leader with over 20 years of experience, to its Board of Directors as the company prepares for a Biologics License Application submission for TA-ERT. - The appointment comes at a pivotal time as Spruce advances TA-ERT for the treatment of Sanfilippo Syndrome Type B (MPS IIIB), which could potentially become the first disease-modifying therapy for children with this rare neurological disorder. - Walbert brings extensive rare disease commercialization expertise from her role as Executive Vice President, U.S. Commercial at Horizon Therapeutics, where she led the successful launch of blockbuster medicine TEPEZZA and managed commercial strategy for over 10 marketed brands.
- Pulse Biosciences received FDA approval for an investigational device exemption study of its nanosecond pulsed field ablation catheter to treat drug-resistant paroxysmal atrial fibrillation. - The company launched a collaboration with MD Anderson Cancer Center to investigate its nPulse technology for treating papillary thyroid microcarcinoma in a first-in-human clinical feasibility study. - The nanosecond pulsed field ablation technology delivers briefer electrical pulses than existing microsecond systems, potentially offering advantages in reducing tissue damage and improving treatment outcomes. - Both studies represent significant advances in minimally invasive ablation techniques, with the cardiac study expected to report data in 2026 and the thyroid cancer study beginning enrollment in early 2026.
- A leading mid-Atlantic health insurer has published a new coverage policy for the Nerivio REN wearable, granting reimbursed access to approximately 3.4 million members in Maryland, Washington D.C., and Northern Virginia. - The policy recognizes Nerivio as medically necessary for both acute and preventive migraine treatment in patients ages 8 and older, making it the first non-pharmacological migraine treatment covered by this provider. - With this expansion, approximately 85 million lives across the U.S. now have coverage for Nerivio, supported by 25 peer-reviewed studies demonstrating the device's clinical efficacy. - A separate study published in the Journal of Clinical Medicine confirms that Nerivio can be safely used simultaneously with continuous glucose monitoring devices, addressing safety concerns for patients with comorbid diabetes and migraine.
- Abbott announced a definitive agreement to acquire Exact Sciences for $105 per share, totaling approximately $21 billion in equity value and $23 billion enterprise value including debt. - The acquisition will position Abbott as a leader in the fast-growing $60 billion U.S. cancer screening and precision oncology diagnostics segments, adding Exact Sciences' portfolio including Cologuard and Oncotype DX tests. - Exact Sciences is projected to generate more than $3 billion in revenue this year with high teens organic growth, and the deal will be immediately accretive to Abbott's revenue growth and gross margin. - The transaction is expected to close in the second quarter of 2026, subject to shareholder approval and regulatory clearances, with Exact Sciences maintaining its Madison presence.
- Strategic alliances in the biomarker industry have accelerated from 2019 to 2025, driven by growing demand for precision medicine, companion diagnostics, and targeted therapies. - Partnerships are dominating the biomarker market, with companies leveraging collaborations to accelerate development and expand market reach through licensing, acquisitions, and strategic alliances. - Rising incidence of chronic diseases like cancer and diabetes, combined with advances in omics and imaging technologies, is fueling increased investment in biomarker-related deals. - Biomarkers are transforming oncology care by enabling companion diagnostics that allow targeted therapies to be administered only to patients likely to benefit, improving efficacy while reducing costs.
