Articles tagged with 'DocCheck-EN' | Bayer

Late-stage development programs with significant potential to drive long-term growth / New R&D strategy and operating model sharpening innovation focus and strengthening early development pipeline in oncology, cardiovascular, neurology & rare disease...

Phase III study ARASTEP initiated in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline / Fifth major cl...

Nubeqa™ now approved for metastatic hormone-sensitive prostate cancer as well as non-metastatic castration-resistant prostate cancer / Additional indication based on data from the pivotal Phase III ARASENS trial ...

In the prospective observational XARENO study, after a two year follow up period, Xarelto was associated with a reduced risk of adverse kidney outcomes and all-cause mortality in patients with non-valvular atrial fibrillation (NVAF) and advanced chro...

European Commission granted approval of Nubeqa™ (darolutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) / Approval is based on Phase III ARASENS trial data...

Submission to the Ministry of Health, Labor, and Welfare (MHLW) in Japan for aflibercept 8 mg in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) is based on positive results of phase III clinical trials, PUL...

Darolutamide approved for metastatic prostate cancer as well as non-metastatic castration-resistant prostate cancer / New approval based on data from the pivotal Phase III ARASENS trial 

Featured presentations include development compound gadoquatrane, a novel contrast agent for MRI / Further research explores potential of AI and digital advances in medical imaging 

New subgroup analysis from Phase III ARASENS trial shows that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel increased overall survival (OS) and improved key clinically relevant endpoints in patients with various t...

Closing follows announcement of acquisition on January 18, 2023 / Acquisition bolsters Bayer’s position in digital medical imaging / Blackford will utilize Bayer’s well established “arm’s length” operating model to preserve the company’s entrepreneur...

European Commission 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 III FIGARO-DKD cardiovascular (...

Filing for aflibercept 8 mg in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) is based on positive results of clinical trials, PULSAR and PHOTON / In both trials, aflibercept 8 mg demonstrated unprecedented...

CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5% compared to ADT with docetaxel alone, with sim...

Ultravist™-300, -370 receives green light for indication extension for use in contrast-enhanced mammography (CEM) in a European Workshare Procedure  / CEM is emerging modality combining digital mammography with the administration of a contrast agent ...

Acquisition is part of Bayer’s innovation strategy in radiology / Blackford Analysis provides cutting-edge radiology AI (artificial intelligence) platform technology / Following closing of the acquisition, Blackford Analysis to become part of Bayer’s...

Strong market uptake of Nubeqa™ and Kerendia™ / Asundexian projected peak sales of more than five billion euros as treatment option for thrombosis and stroke prevention  / High-value late-stage development portfolio  / Positive study outcomes from ce...

CHMP opinion is based on the results from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), which included approximately 7,400 patients across a broad range of disease...

New clinical data for the development compound gadoquatrane, a novel MRI contrast agent, presented at RSNA 2022 / Three new partnerships, AI app accelerator program and pipeline updates to be featured / Collaboration agreements signed to expand offer...

Recommendation 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 / Bayer will apply for a patent term extension for the pat...

Aflibercept 8 mg maintained 16-week dosing intervals in up to 89% of patients with as few as 5 injections until week 48 / Aflibercept 8 mg demonstrated non-inferior vision gains to Eylea® (aflibercept 2 mg) with 83% of patients with neovascular (wet)...

FIDELITY: Late-breaking data from pooled, post-hoc analysis will provide new insights into the efficacy and safety of Kerendia in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) who have sustained an acute change in estimated glo...

The REALISE study explored symptom burden and impact of menopause symptoms in women across multiple countries, and the views of their treating physicians.  / This study confirmed vasomotor symptoms (VMS) are considered the most common and distressing...

Study plans to investigate elinzanetant as non-hormonal treatment for vasomotor symptoms caused by endocrine therapy in breast cancer patients  / Elinzanetant is an innovative non-hormonal development compound in development for the treatment of vaso...

Mirena® (52mg LNG IUS), Bayer’s long-acting reversible intrauterine system, received regulatory approval in the European Workshare Procedure for up to eight years in contraception, now offering the longest contraceptive duration of use for any hormon...

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 ...

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...

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

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...

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...

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...