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In an interview with BioSpace, Marianne De Backer, Head of Business Development & Licensing in Bayer’s Pharmaceuticals Division, outlined Bayer’s thought process for opening its purse strings and diving into the deep end of the cell and gene therapy space.
Bayer Announces U.S. FDA Accepts New Drug Application and Grants Priority Review for Investigational Drug Finerenone for Patients with Chronic Kidney Disease and Type 2 Diabetes
Bayer announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted Priority Review for finerenone, an investigational drug for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). This regulatory submission was based on Phase III FIDELIO-DKD trial data, which were recently presented at the American Society of Nephrology’s (ASN) Kidney Week Reimagined 2020,
U.S. FDA Approves Addition of Overall Survival and Other Secondary Endpoint Data to NUBEQA® (darolutamide) Prescribing Information
U.S. FDA Approves Addition of Overall Survival and Other Secondary Endpoint Data to NUBEQA ® (darolutamide) Prescribing Information Phase III data showed treatment with NUBEQA resulted in a 31% reduction in risk of death, with a statistically significant improvement in overall survival (OS) compared to placebo (HR=0.69, 95% CI 0.53-0.88; p=0.003), giving men with non-metastatic castration-resistant prostate cancer (nmCRPC)
Bayer has signed a collaboration and services agreement with CureVac N.V., a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid.
As part of the We’re for Her initiative, four health clinics across the country will receive grants from Direct Relief to help address access barriers to contraceptives
Bayer and Tempus Initiate Collaboration to Advance Patient Access to Genomic Testing and Precision Medicine
Bayer and Tempus, leaders in precision medicine and artificial intelligence (AI), announced a new collaboration designed to provide broader access to genomic testing and tailored treatment approaches for the oncology community. The collaboration will include an initiative to help facilitate patient identification for precision oncology by providing testing, via the Tempus xT broad-panel genomic sequencing as
Bayer Radiology is announcing Radimetrics ® v3.0, the newest evolution of its enterprise dose management application. The newly designed system supports many of the latest accreditation standards on dose reporting and tracking, protoco
Bayer and Atara Biotherapeutics Enter Strategic Collaboration for Mesothelin-Targeted CAR T-cell Therapies for Solid Tumors
Bayer and Atara Biotherapeutics, Inc. announced an exclusive worldwide license agreement and research, development and manufacturing collaboration for mesothelin-directed CAR T-cell therapies for the treatment of solid tumors.
The collaboration with Atara will focus on developing an off-the-shelf T-cell immunotherapy for high mesothelin-expressing tumors.
Bayer and Blackford Analysis have entered into a development and license agreement to establish an artificial intelligence (AI) platform for medical imaging. This agreement supports Bayer’s commitment to expanding its AI capabilities and accelerating innovation in radiology
New pilot roll-out to promote innovation, minimize costs, and maximize performance
Bayer Presents FIDELIO-DKD Phase III Study Cardiovascular Subgroup Analysis of Patients With Chronic Kidney Disease and Type 2 Diabetes
Late-breaking data presented at AHA 2020 Scientific Sessions and published simultaneously in Circulation
11/17/2020Finerenone is an oral, non-steroidal selective mineralocorticoid receptor antagonist (MRA).
Metagenomi is a genomic medicines company pioneering precision gene editing systems to advance curative therapies for oncology and genetic diseases
Bayer Submits Regulatory Applications for Investigational Drug Finerenone in the U.S. and the EU for Patients with Chronic Kidney Disease and Type 2 Diabetes
Bayer today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of the investigational drug finerenone, for patients with ch
Bayer is paying $2 billion upfront for AskBio's AAV-based gene therapy pipeline of treatments for Pompe disease, among others, and could pay an additional $2 billion in potential milestones.
Bayer’s FIDELIO-DKD Phase III Study Demonstrated Investigational Drug Finerenone Significantly Reduced Renal and Cardiovascular Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes
Finerenone is a potential first-in-class investigational, non-steroidal, selective mineralocorticoid receptor antagonist (MRA) that works on the pathway of MR overactivation, a key contributor to disease progression in patients with chronic kidney disease and type 2 diabetes FIDELIO-DKD is the first large contemporary positive outcomes study in patients with chronic kidney disease and type 2 diabetes with a primary composite endpoint exclusively cons
FDA Approves FoundationOne®CDx as Companion Diagnostic for Vitrakvi® (larotrectinib), to Aid in Identifying NTRK Fusion-Positive Patients
Detection of genomic alterations that drive the growth and spread of the tumor can guide treatment decisions for cancer therapies, including available biomarker driven treatments FoundationOne ® CDx analyzes substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes as well as select rearrangements and genomic signatures across all solid tumors, including the three NTRK gene fusions ( NTRK 1, NTRK 2
Aliqopa™ (copanlisib) in Combination With Rituximab Meets Primary Endpoint in Patients With Relapsed Indolent Non-Hodgkin's Lymphoma
Phase III study CHRONOS-3 in patients with relapsed indolent Non-Hodgkin's Lymphoma (iNHL) who have received one or more prior lines of rituximab-containing therapy meets primary endpoint of progression-free survival
Bayer to Present Results From Phase III FIDELIO-DKD Study with Finerenone in Patients with Chronic Kidney Disease and Type 2 Diabetes during Late-Breaker Session at the American Society of Nephrology’s Kidney Week 2020
Bayer will present detailed results from the Phase III FIDELIO-DKD study assessing the use of the investigational drug finerenone on kidney and cardiovascular outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) during scientific sessions of the upcoming American Society of Nephrology’s (ASN) Kidney Week, October 22-25, 2020. Addition