Articles tagged with 'SPECIALIZED PRESS' | Bayer

Newsroom Bayer (SPECIALIZED PRESS)

2022
September
20,
2022
| 11:45 AM Europe/Amsterdam
New post-hoc analyses from the prespecified pooled analysis FIDELITY will provide insights into the effects of finerenone on kidney and cardiovascular outcomes by use of glucagon-like peptide-1 receptor agonists (GLP-1RA) at baseline, as well as by b...
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September
11,
2022
| 10:15 AM Europe/Amsterdam
Consistent benefits were also seen in other patient-relevant endpoints, including all-cause and prostate cancer-related death and cumulative incidence of adverse events (AEs) of special interest...
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September
08,
2022
| 14:59 PM Europe/Amsterdam
Aflibercept 8 mg meets primary endpoints in two global pivotal studies in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) achieving non-inferior improvements in best corrected visual acuity to Eylea® (aflibe...
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September
02,
2022
| 10:15 AM Europe/Amsterdam
U.S. Food and Drug Administration (FDA) granted label update for Kerendia™ (finerenone) to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) associated with type 2 diabetes...
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August
30,
2022
| 14:00 PM Europe/Amsterdam
In prostate cancer, a key therapeutic area for Bayer, new patient-relevant data from the ARASENS Phase III study in metastatic hormone-sensitive prostate cancer (mHSPC) will be showcased, as well as data from the RALU study comprising real-world evid...
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August
22,
2022
| 09:00 AM Europe/Amsterdam
Late-breaking data from a new exploratory analysis of FIDELITY investigating causes of mortality in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) treated with Kerendia™ (finerenone) or placebo / New Phase IIb data from PACIFIC ...
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August
18,
2022
| 14:30 PM Europe/Amsterdam
Mirena®, Bayer’s long-acting reversible intrauterine system, now approved by U.S. FDA for up to eight years in contraception / Mirena (52mg LNG IUS) now offers the longest contraceptive duration of use for any hormonal intrauterine system / The IUS i...
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August
08,
2022
| 08:30 AM Europe/Amsterdam
Darolutamide now has indications in both non-metastatic castration-resistant prostate cancer (nmCRPC) for men at high risk of developing metastatic disease and metastatic hormone-sensitive prostate cancer (mHSPC) / Today’s approval under the FDA’s Re...
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July
28,
2022
| 13:05 PM Europe/Amsterdam
Berlin, Germany, July 28, 2022 – Bayer today announced completion of two Phase 2b clinical trials: the RE-THINC ESRD trial and the CONVERT trial. The RE-THINC ESRD trial evaluated the safety of fesomersen, Bayer’s investigational, subcutaneously admi...
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July
14,
2022
| 08:00 AM Europe/Amsterdam
Supports ongoing transformation of Bayer’s Pharma business to focus on key areas of future medical innovation / Transaction value of up to 500 million Euro / Closing expected by end of 2022...
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July
11,
2022
| 08:30 AM Europe/Amsterdam
Featured presentations include development compound gadoquatrane, a novel contrast agent for MRI / Further data to highlight research efforts to drive innovation in AI...
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July
04,
2022
| 09:00 AM Europe/Amsterdam
New subgroup analysis from Phase III ARASENS trial in patients with metastatic hormone-sensitive prostate cancer (mHSPC), shows that darolutamide plus androgen deprivation therapy (ADT) and docetaxel provides consistently favorable overall survival (...
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June
30,
2022
| 08:30 AM Europe/Amsterdam
Despite available treatment options, many patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are progressing to kidney failure and premature death / Kerendia™ (finerenone) is the first non-steroidal, selective mineralocorticoid rece...
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June
28,
2022
| 14:00 PM Europe/Amsterdam
AI applications for medical imaging can improve prioritization, lesion detection, quantification and productivity / Cloud-hosted platform provides access to AI applications that integrate into standard medical imaging workflow / Market introduction t...
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June
21,
2022
| 12:00 PM Europe/Amsterdam
Berlin, June 21, 2022 - The Ministry of Health, Labor and Welfare in Japan has approved the use of the oral Factor Xa inhibitor rivaroxaban (Xarelto™) (2.5 mg twice daily, used in combination with aspirin 81-100 mg once daily) to treat patients with ...
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June
03,
2022
| 09:00 AM Europe/Amsterdam
New post-hoc analysis from FIDELITY, a prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD, evaluated the effect of Kerendia™ (finerenone) by baseline HbA1c categories, HbA1c variability, and diabetes duration in patients with chronic kidney d...
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May
23,
2022
| 16:39 PM Europe/Amsterdam
Data from the exploratory post hoc analysis of FIDELITY also highlight the potential of Kerendia™ (finerenone) to reduce the incidence of hospitalization for heart failure (HHF), with a more pronounced effect in patients with left ventricular hypertr...
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May
23,
2022
| 14:00 PM Europe/Amsterdam
Results from the extension part of the COMPASS study support the long-term use of Xarelto (rivaroxaban) plus aspirin for vascular protection in patients with chronic coronary artery disease (CAD) and/or peripheral artery disease (PAD) / The XATOA reg...
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May
19,
2022
| 14:00 PM Europe/Amsterdam
Prostate cancer remains a key focus area with darolutamide data in non-metastatic castration-resistant prostate cancer (high-risk nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC), and radium-223 dichloride research in metastatic castr...
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May
19,
2022
| 10:00 AM Europe/Amsterdam
Studied in adults with symptomatic chronic heart failure and reduced ejection fraction who are stabilized after a recent decompensation event with IV therapy / Approved in China to reduce the risk of heart failure (HF) hospitalization or the need for...
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May
17,
2022
| 09:00 AM Europe/Amsterdam
New subgroup analysis from FIDELITY, a prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD, will reveal further insights into the efficacy and safety of Kerendia™ (finerenone) in patients with stage 4 chronic kidney disease (CKD) and type 2 di...
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May
03,
2022
| 14:00 PM Europe/Amsterdam
Application is being reviewed concurrently among participating international health authorities under the FDA Oncology Center of Excellence’s (OCE) Project Orbis initiative...
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April
22,
2022
| 10:30 AM Europe/Amsterdam
Submission to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for an additional indication in patients with metastatic hormone-sensitive prostate cancer (mHSPC) / Submission based on data from the pivota...
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April
13,
2022
| 08:40 AM Europe/Amsterdam
Precision oncology treatment Vitrakvi™ (larotrectinib) approved for the treatment of NTRK fusion-positive advanced or recurrent solid tumors in adult and pediatric patients in China / In clinical studies of patients with TRK fusion solid tumors, laro...
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April
04,
2022
| 19:00 PM Europe/Amsterdam
Cardiovascular (CV) complications are among the most frequent causes of death for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), with atherosclerotic CV disease (ASCVD) on top of CKD and T2D having the highest risk of all-cause...
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April
04,
2022
| 10:00 AM Europe/Amsterdam
In the prospective observational XARENO study, after one year follow up, Xarelto was associated with a greater net clinical benefit and a reduced risk of kidney failure in patients with non-valvular atrial fibrillation (NVAF) and advanced chronic kid...
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April
03,
2022
| 18:15 PM Europe/Amsterdam
Data from the PACIFIC-AF trial demonstrated lower observed rates of ISTH major and clinically relevant non-major bleeding for asundexian (a FXIa inhibitor) compared with apixaban in patients with atrial fibrillation at risk of stroke / The data, simu...
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March
29,
2022
| 08:30 AM Europe/Amsterdam
Pre-specified subgroup analyses from FIDELITY explore the efficacy and safety of finerenone (Kerendia™) in primary and secondary prevention of cardiovascular (CV) and kidney outcomes in patients with a combination of cardiovascular disease, chronic k...
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March
28,
2022
| 09:00 AM Europe/Amsterdam
Despite available treatment options, many patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are progressing to kidney failure or premature death / Kerendia™ (finerenone) is the first non-steroidal, selective mineralocorticoid recep...
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March
16,
2022
| 08:30 AM Europe/Amsterdam
Regulatory submission is based on positive data from the pivotal Phase III FIGARO-DKD study, published in the New England Journal of Medicine, which covers a broad range of disease severities of chronic kidney disease associated with type 2 diabetes ...
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