Articles tagged with 'DocCheck' | Bayer

Newsroom Bayer (DocCheck)

2022
September
26,
2022
| 09:00 AM Europe/Amsterdam
Approval is based on the Phase III study FIREFLEYE and data from the follow-up study FIREFLEYE NEXT / Retinopathy of prematurity (ROP) can lead to severe visual impairment and blindness / With ROP, Eylea® is now approved for six indications in Japan ...
Read more
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...
Read more
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...
Read more
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...
Read more
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...
Read more
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...
Read more
August
29,
2022
| 09:24 AM Europe/Amsterdam
Data from FIDELITY, a prespecified pooled analysis of the Phase III FIDELIO-DKD and FIGARO-DKD studies, highlight the potential of Kerendia™ (finerenone) to reduce the incidence of sudden cardiac death / While in the overall FIDELITY population, the ...
Read more
August
28,
2022
| 09:14 AM Europe/Amsterdam
The OCEANIC program will start with two Phase III studies investigating the efficacy and safety of asundexian in prevention of stroke events in patients with atrial fibrillation as well as patients with a non-cardioembolic ischemic stroke or high-ris...
Read more
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 ...
Read more
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...
Read more
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...
Read more
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...
Read more
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...
Read more
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...
Read more
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 (...
Read more
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...
Read more
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...
Read more
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 ...
Read more
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...
Read more
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...
Read more
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...
Read more
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...
Read more
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...
Read more
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...
Read more
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...
Read more
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...
Read more
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...
Read more
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...
Read more
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...
Read more
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...
Read more