Articles tagged with 'Export-PH' | 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 ...

Rune Labs’ StriveStudy platform and Emerald Innovations’ Emerald wireless monitoring sensor will passively capture data on Parkinson’s disease impact on function of fifty study participants in BlueRock’s global non-interventional clinical study.  / C...

Research Triangle Park, N.C.– March 9, 2023 – Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG, today announced that Gustavo Pesquin will become the company’s next Chief Executive Officer (C...

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...

LGMD is a Rare Form of Muscular Dystrophy with No Approved Therapies

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...

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...

Jeffrey Hatfield becomes Chairman of the Board of Directors at Vividion Therapeutics

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...

Bayer to speed up its in-silico research and development with Google Cloud’s high-speed processors / Collaboration aims to enable Bayer to run large quantum chemistry calculations at scale using Google Tensorflow Processing Units ...

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...

Research Triangle Park, N.C. (January 9, 2023) - Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG, announced today that it has signed a multi-year research collaboration and option agreement...

-- Certification expands Viralgen's capacity threefold and positions the company as a world-leading CDMO ---- New facility operates single-use bioreactors from 50 to 2,000 liters and manufactures research, clinical and commercial grade rAAV vectors u...

Research Triangle Park, N.C. (December 20, 2022) - Asklepios BioPharmaceutical, Inc. (AskBio), a wholly-owned and independently-operated subsidiary of Bayer AG, today announced that the FDA’s approval of a new adeno-associated virus (AAV) gene therap...

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...

San Diego – November 9, 2022 – Vividion Therapeutics, Inc., a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune diso...

Group sales increase by 5.7 percent (Fx & portfolio adj.) to 11.281 billion euros  / EBITDA before special items rises by 17.3 percent to 2.451 billion euros / Crop Science achieves strong sales gains – sales also up at Pharmaceuticals and Consumer H...

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...