Articles tagged with 'Further Health Topics' | Bayer

Newsroom Bayer (Further Health Topics)

2023
June
22,
2023
| 08:29 AM Europe/Amsterdam
Phase III study FINE-ONE will evaluate the efficacy and safety of finerenone versus placebo in delaying the progression of chronic kidney disease (CKD) in adults with CKD and type 1 diabetes (T1D) / CKD affects up to 40% of people with T1D / A quarte...
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June
15,
2023
| 08:59 AM Europe/Amsterdam
New post hoc analysis from FIDELITY, a prespecified pooled analysis of FIDELIO-DKD and FIGARO-DKD, will validate a model predicting the risk of chronic kidney disease (CKD) progression in adults at all stages of CKD / Update on FINEGUST study, descri...
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May
17,
2023
| 13:59 PM Europe/Amsterdam
Chinese National Medical Products Administration granted approval for a label update to extend the indication of Kerendia™ to early stages of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) and to include findings from the Phase II...
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2020
November
30,
2020
| 17:30 PM Europe/Amsterdam
Innovative combination space spray solution demonstrates improved efficacy in controlling Aedes mosquitoes - vectors of arboviral diseases
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September
09,
2020
| 13:00 PM Europe/Amsterdam
Drug Discovery partnership and equity investment led by Leaps by Bayer in Series D financing round / Digitally-powered drug discovery to address fibrotic diseases with previously undiscovered mechanisms and to deliver novel therapies to patients fast...
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April
21,
2020
| 14:30 PM Europe/Amsterdam
Investigation of combination therapies including Bayer’s chloroquine and interferon beta-1b to foster much needed solutions for patients in fight against coronavirus pandemic / Bayer Canada to make CAD 1.5 million (approximately 1 million euros) fina...
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March
30,
2020
| 17:15 PM Europe/Amsterdam
Oral androgen receptor inhibitor (ARi) Nubeqa™ (darolutamide) approved for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease / Approval is based on Phase III ...
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January
31,
2020
| 12:30 PM Europe/Amsterdam
CHMP opinion is based on Phase III ARAMIS trial data evaluating the efficacy and safety of darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT / Final decision from the European Commission is anticipated within the comin...
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January
23,
2020
| 07:30 AM Europe/Amsterdam
Marketing authorization granted for the treatment of men with non-metastatic castration-resistant prostate cancer
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2019
May
31,
2019
| 16:00 PM Europe/Amsterdam
Results of a new post-hoc analysis showed that treatment with darolutamide plus androgen deprivation therapy (ADT) delayed worsening of urinary and bowel symptoms versus placebo plus ADT / Exposure-adjusted incidences of treatment-emergent adverse ev...
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April
29,
2019
| 14:00 PM Europe/Amsterdam
Berlin, April 29, 2019 - Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted Priority Review to darolutamide for the treatment of non-metastatic castration-resistant prostate cance...
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March
08,
2019
| 07:30 AM Europe/Amsterdam
Third submission for darolutamide in two weeks underscores Bayer´s commitment to fill an unmet need for men with nmCRPC worldwide / Regulatory submission based on positive data from Phase III study ARAMIS...
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March
05,
2019
| 07:00 AM Europe/Amsterdam
Regulatory submission based on positive data from Phase III ARAMIS study
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February
27,
2019
| 06:00 AM Europe/Amsterdam
Berlin, February 27, 2019 - Bayer today announced the completion of the rolling submission of a New Drug Application (NDA) for darolutamide to the U.S. Food and Drug Administration (FDA). The submission, which was initiated in December 2018, is based...
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February
14,
2019
| 22:45 PM Europe/Amsterdam
Statistically significant improvement in metastasis-free survival (MFS), with a median MFS of 40.4 months with darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT (18.4 months) / Positive trend in overall survival with a 29% ...
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2018
October
24,
2018
| 07:30 AM Europe/Amsterdam
The safety and tolerability observed in the trial were consistent with previously published data on darolutamide
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2017
November
24,
2017
| 08:30 AM Europe/Amsterdam
Berlin, November 24, 2017 - Bayer today announced that INHALE, a global Phase III clinical study program investigating Amikacin Inhale in addition to standard of care in intubated and mechanically ventilated patients with Gram-negative pneumonia, did...
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