Patient Follow Articles & Analysis
28 news found
Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx”), a global leader in minimally invasive treatments for severe lung disease, announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the Zephyr® Endobronchial Valve for treating severe COPD/emphysema patients following a positive recommendation by Pharmaceuticals and ...
The PACIFIC-STROKE2 and PACIFIC-AMI3 Phase IIb trials compared the safety and efficacy of asundexian with placebo in patients following acute non-cardioembolic ischemic stroke or acute myocardial infarction (AMI), respectively. ...
ByBayer AG
“These results amplify the extensive body of clinical evidence empowering physicians and patients to make personalized early-stage breast cancer treatment decisions and enhance patient outcomes.” Oral Abstract Presentation Title: Assessing the benefit of adjuvant endocrine therapy in patients following breast ...
Acutus Medical (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced successful completion of patient enrollment in the company’s AcQForce™ Flutter Investigational Device Exemption (IDE) clinical trial which enrolled 110 patients at 21 sites globally. ...
” Recent Highlights At the Annual Meeting of the European Society for Blood and Bone Marrow Transplantation (EBMT) in March 2022, AlloVir reported updated preliminary data from the open-label Phase 2 study assessing the safety and efficacy of posoleucel for multi-virus prevention in high-risk allo-HCT patients. The updated data set, which includes more ...
ByKalaris
Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead investigational multi-virus-specific T cell therapy, posoleucel, for the prevention of clinically significant infections and disease from six devastating viruses that commonly impact high-risk adult and pediatric patients following allogeneic ...
ByKalaris
Safety and efficacy will continue to be followed through Week 26. Posoleucel has the potential to fundamentally transform the treatment landscape for allo-HCT by preventing life-threatening viral diseases and infections, either as a prophylactic therapy in high-risk patients or as a preemptive therapy in patients who have already reactivated one ...
ByKalaris
Allogeneic discogenic cell therapy was well tolerated and produced clinically meaningful, statistically significant improvements in low back pain, function, and quality of life by 12 weeks following intradiscal injection; improvements were sustained at the one-year interim readout with additional data to follow at 18 and 24 months. ...
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities. ...
Patients received 0.89 mg of tivozanib orally once daily for 21 days followed by seven days off therapy in combination with 1500 mg of durvalumab intravenously (IV) on day one given every four weeks, on a 28 day cycle. ...
An exploratory analysis from the PREDATOR study of metastatic colorectal cancer (mCRC) patients undergoing surgicalAuthors (in order): Halla Nimeiri1, Amanda Young1, Russell Madison1, Alexander Fine1, Ole Gjoerup1, Fotios Loupakis2, Matteo Fassan2,3, Sara Lonardi2, Shruti Sharma4, Hsin-Ta Wu4, Alexey Aleshin4, Elise Renkonen1, Priti Hegde11Foundation Medicine Inc, 2Istituto ...
Revita has previously obtained Breakthrough Device Designation from the FDA to improve glycemic control and eliminate insulin needs in T2D patients who are inadequately controlled on long-acting insulin. In T2Di, clinical assessments observed in eight treated patients followed through at least four weeks demonstrated no adverse events of special ...
” A Phase 3 registrational study (NCT05179057) of posoleucel for the treatment of AdV viremia is now open and enrolling pediatric and adult patients following allo-HCT. This study is the second Phase 3 registrational study of posoleucel, following the initiation of the Phase 3 study for the treatment of virus-associated HC last year. ...
ByKalaris
Women with a Recurrence Score result of 0 to 25 were randomised to treatment with hormone therapy alone or chemotherapy followed by hormone therapy. Randomised patients were stratified based on their Recurrence Score result, menopausal status and type of lymph node surgery. Further analyses and additional patient follow up are ...
SPEARHEAD-1 trial will meet its primary endpoint and data will be used to support BLA filing for afami-cel next year The overall response rate (ORR) per Independent Review was 34% (36% in patients with synovial sarcoma and 25% for patients with MRCLS) and the disease control rate was 85% As of the data cut-off, afami-cel has shown a favorable benefit:risk ...
Patients may be actively monitored with the device for up to 48 hours, with results compared with data from regularly scheduled CT scans. ...
Ivantis, Inc., developer of the novel Hydrus® Microstent, a minimally invasive glaucoma surgery (MIGS) device designed to lower eye pressure for open-angle glaucoma patients, today announced that it has entered into an agreement with Glaukos Corporation to settle and dismiss all pending global litigation between them. ...
The U.S. study completed enrollment in Q1 2020, passed all three planned mid-trial safety reviews and has commenced its second year of patient follow-up. For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03347708. “The achievement of patient enrollment in Japan and our one-year follow-up in the ...
The study reports that use of vMap™ computational 12-lead ECG analysis was able to provide arrhythmia insights beyond those available from a standard 12-lead ECG in patients following COVID-19 infection. ...
First, the new design incorporates guided workflows, which direct clinicians step-by-step through the patient management process from initial Inspire activation, to titration sleep studies, and all the way through long-term patient follow-up visits. ...