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Pool Analysis Articles & Analysis

26 news found

Bayer to start Phase III study with finerenone in adults with chronic kidney disease and type 1 diabetes

Bayer to start Phase III study with finerenone in adults with chronic kidney disease and type 1 diabetes

UACR is planned to be used as a marker to demonstrate the delay of kidney disease progression. In the prespecified FIDELITY pooled analysis of the pivotal Phase III FIDELIO-DKD and FIGARO-DKD studies in people with chronic kidney disease associated with type 2 diabetes, finerenone reduced the risk of chronic kidney disease progression as well as fatal and ...

ByBayer AG


New data from pivotal studies with aflibercept 8 mg

New data from pivotal studies with aflibercept 8 mg

The following new abstracts for aflibercept 8 mg will be presented at ARVO 2023: The pooled safety analysis compares the safety of aflibercept 8 mg with aflibercept 2 mg across the clinical trial program which includes data from the phase II trial CANDELA in nAMD and the pivotal phase II/III trial PHOTON in DME and the phase III trial PULSAR in nAMD. ...

ByBayer AG


Kerendia (finerenone) granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes

Kerendia (finerenone) granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes

Having randomized more than 13,000 patients with CKD and T2D around the world, the Phase III program with finerenone in CKD and T2D comprises two completed and published studies, FIDELIO-DKD and FIGARO-DKD, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes. The prespecified FIDELITY pooled ...

ByBayer AG


Finerenone receives positive CHMP opinion for EU-label extension for broad range of patients with chronic kidney disease and type 2 diabetes

Finerenone receives positive CHMP opinion for EU-label extension for broad range of patients with chronic kidney disease and type 2 diabetes

Having randomized more than 13,000 patients with CKD and T2D around the world, the Phase III program with finerenone in CKD and T2D comprises two completed and published studies, FIDELIO-DKD and FIGARO-DKD, evaluating the effect of finerenone versus placebo on top of standard of care on both renal and cardiovascular outcomes. The prespecified FIDELITY pooled ...

ByBayer AG


Detailed data from pivotal studies with aflibercept 8 mg demonstrate sustained improvements in visual acuity and anatomic measures with large majority of patients maintaining treatment intervals of 16 weeks at week 48

Detailed data from pivotal studies with aflibercept 8 mg demonstrate sustained improvements in visual acuity and anatomic measures with large majority of patients maintaining treatment intervals of 16 weeks at week 48

Patients were randomized in three different arms and all patients in the aflibercept 8 mg arms were continuously evaluated under stringent, clinically relevant, and patient focused dosing regimen modification (DRM) criteria. 77% of nAMD and 89% of DME patients maintained every 16-week dosing intervals with aflibercept 8 mg at week 48 in the clinical trials. In the pooled ...

ByBayer AG


Bayer to present new cardiorenal data for Kerendia (finerenone) across a broad range of patients with early to late-stage chronic kidney disease and type 2 diabetes

Bayer to present new cardiorenal data for Kerendia (finerenone) across a broad range of patients with early to late-stage chronic kidney disease and type 2 diabetes

This data will include new post-hoc analyses of FIDELITY, a prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD, as well as the design of the Phase II CONFIDENCE study, investigating simultaneous initial combination therapy with finerenone and an SGLT2-inhibitor in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Kerendia FIDELITY ...

ByBayer AG


Kerendia (finerenone) receives updated label in the U.S. to include findings from Phase III FIGARO-DKD cardiovascular outcomes study

Kerendia (finerenone) receives updated label in the U.S. to include findings from Phase III FIGARO-DKD cardiovascular outcomes study

FIDELITY (FInerenone in chronic kiDney diseasE and type 2 diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial programme analYsis), including the FIDELIO-DKD and FIGARO-DKD studies, comprises the largest Phase III cardiorenal outcomes clinical trial program in >13,000 patients with CKD and T2D. The prespecified FIDELITY pooled analysis ...

ByBayer AG


Kerendia (finerenone) approved in China for the treatment of adults with chronic kidney disease associated with type 2 diabetes

Kerendia (finerenone) approved in China for the treatment of adults with chronic kidney disease associated with type 2 diabetes

FIDELITY (FInerenone in chronic kiDney diseasE and type 2 diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial programme analYsis), including the FIDELIO-DKD and FIGARO-DKD studies, comprises the largest Phase III cardiorenal outcomes clinical trial program in >13,000 patients with CKD and T2D. The prespecified FIDELITY pooled analysis ...

ByBayer AG


iSTAR Medical Presents Positive Consistent Results for MINIject Across Three International Glaucoma Trials

iSTAR Medical Presents Positive Consistent Results for MINIject Across Three International Glaucoma Trials

Analysis provides further validation of MINIject®’s meaningful and sustained efficacy in open angle glaucoma patients No safety concerns with corneal endothelial health reported across all three trials MINIject® delivers positive, consistent results up to two-year follow-up in patients across Central and South America, Asia and Europe WAVRE, Belgium ...

ByiSTAR Medical SA


Helius Medical Technologies, Inc. Presents Poster at the 2022 Consortium of Multiple Sclerosis Centers (“CMSC”) Annual Meeting

Helius Medical Technologies, Inc. Presents Poster at the 2022 Consortium of Multiple Sclerosis Centers (“CMSC”) Annual Meeting

Favit-VanPelt. Study Conclusions In this analysis of a real-world dataset of patients with MS with generally long duration of disease, translingual neurostimulation (PoNS Therapy) combined with a therapeutic exercise program significantly improved gait deficit at Week 2, the earliest evaluated time point, and at every subsequent time point. ...

ByHelius Medical Technologies, Inc.


Aurinia Presents Data Demonstrating LUPKYNIS (voclosporin) is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations

Aurinia Presents Data Demonstrating LUPKYNIS (voclosporin) is Effective in Achieving Proteinuria Treatment Targets in Lupus Nephritis Defined by EULAR/ERA Recommendations

(NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the course of autoimmune disease, presented data demonstrating the efficacy of LUPKYNIS® (voclosporin) for the treatment of people with lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE), in achieving the proteinuria treatment targets recommended ...

ByAurinia Pharmaceuticals Inc.


Aurinia Presents Results from the Two-Year AURORA 2 Continuation Study at the 2022 European Renal Association (ERA) Congress

Aurinia Presents Results from the Two-Year AURORA 2 Continuation Study at the 2022 European Renal Association (ERA) Congress

Use of LUPKYNIS was safe and well tolerated in patients for up to three years of treatment, with no new safety signals In AURORA 2, long-term treatment with LUPKYNIS led to a clinically relevant preservation of kidney function in LN patients A pooled analysis from the AURA-LV and AURORA 1 studies, also presented at ERA, showed early treatment response to ...

ByAurinia Pharmaceuticals Inc.


Shockwave IVL Coronary Studies Demonstrate Excellent PCI Outcomes in Both Women and Men at One Year

Shockwave IVL Coronary Studies Demonstrate Excellent PCI Outcomes in Both Women and Men at One Year

Unlike previous reports with atherectomy that have shown worse angiographic complications in women versus men,i a pooled analysis of the Disrupt CAD III & IV studies showed that IVL was equally safe and effective in men (n=342) and women (n=106). ...

ByShockwave Medical Inc.


CathWorks FFRangio System outcomes study to be presented at ACC 2022

CathWorks FFRangio System outcomes study to be presented at ACC 2022

“FFRangio has been in use in our cath lab since 2016 and we have taken part in several studies demonstrating its excellent diagnostic performance compared to the gold standard wire-based FFR, culminating in the pivotal FAST-FFR trial and our leading role in conducting a pooled analysis that compared FFRangio to wire-based FFR. Based on the results of these ...

ByCathWorks


Bayer receives approval in Japan for Kerendia (finerenone), a new treatment for adults with chronic kidney disease and type 2 diabetes

Bayer receives approval in Japan for Kerendia (finerenone), a new treatment for adults with chronic kidney disease and type 2 diabetes

FIDELITY (FInerenone in chronic kiDney diseasE and type 2 diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial programme analYsis), including the FIDELIO-DKD and FIGARO-DKD studies, comprises the largest Phase III cardiorenal outcomes clinical trial program in >13,000 patients with CKD and T2D. The prespecified FIDELITY pooled analysis ...

ByBayer AG


Palisade Bio (Nasdaq: PALI) Announces Analysis Demonstrating LB1148 Reduced The Extent And Severity Of Post-Surgical Intraabdominal Adhesions By 93%

Palisade Bio (Nasdaq: PALI) Announces Analysis Demonstrating LB1148 Reduced The Extent And Severity Of Post-Surgical Intraabdominal Adhesions By 93%

Data from Pooled-Analysis of Enteral Protease Inhibitor LB1148 Demonstrated 72% Reduction in the Risk of Adhesion Formation in Patients Undergoing Bowel Resection Surgery Company to Host Conference Call on Wednesday, March 16, 2022, at 8:30 a.m. ...

ByPalisade Bio


Palisade Bio (Nasdaq: PALI) To Present New Clinical Data Of LB1148 For Preventing Adhesions In Conjunction With Next Big Thing Session At Society Of American Gastrointestinal And Endoscopic Surgeons 2022 Annual Meeting

Palisade Bio (Nasdaq: PALI) To Present New Clinical Data Of LB1148 For Preventing Adhesions In Conjunction With Next Big Thing Session At Society Of American Gastrointestinal And Endoscopic Surgeons 2022 Annual Meeting

(Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, was selected to present an ePoster entitled “Pooled-Analysis of Incidence and Severity of Post-Surgical Intraabdominal Adhesions following Bowel Resection Surgery and Treatment with Enteral Protease Inhibitor ...

ByPalisade Bio


Bayer’s new treatment Kerendia (finerenone) approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes

Bayer’s new treatment Kerendia (finerenone) approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes

FIDELITY (FInerenone in chronic kiDney diseasE and type 2 diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial programme analYsis), including the FIDELIO-DKD and FIGARO-DKD studies, comprises the largest Phase III cardiorenal outcomes clinical trial program to evaluate the occurrence of progression of kidney disease as well as fatal and nonfatal CV events in >13,000 patients ...

ByBayer AG


Axogen to Participate at AAHS ASPN ASRM 2022 Annual Meetings

Axogen to Participate at AAHS ASPN ASRM 2022 Annual Meetings

“Neurotization Techniques and Outcomes in Innervated Breast Reconstruction: A Systematic Review and Pooled Analysis” at the AAHS/ASPN/ASRM Outstanding Paper Session on Saturday January 15. ...

ByAxogen (AXGN)


Bayer receives positive CHMP opinion for finerenone as a new treatment for adult patients with chronic kidney disease associated with type 2 diabetes

Bayer receives positive CHMP opinion for finerenone as a new treatment for adult patients with chronic kidney disease associated with type 2 diabetes

FIDELITY (FInerenone in chronic kiDney diseasE and type 2 diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial programme analYsis), including the FIDELIO-DKD and FIGARO-DKD studies, comprises the largest Phase III cardiorenal outcomes clinical trial program to evaluate the occurrence of progression of kidney disease as well as fatal and nonfatal CV events in >13,000 patients ...

ByBayer AG

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