BAYER

Bayer Presents New Subgroup Analyses for KERENDIA® (finerenone) for Chronic Kidney Disease Associated With Type 2 Diabetes With or Without History of Atherosclerotic Cardiovascular Disease

Retrieved on: 
Monday, April 4, 2022

These subgroup analyses investigate outcomes in patients suffering from chronic kidney disease associated with type 2 diabetes, with or without a history of atherosclerotic cardiovascular disease.

Key Points: 
  • These subgroup analyses investigate outcomes in patients suffering from chronic kidney disease associated with type 2 diabetes, with or without a history of atherosclerotic cardiovascular disease.
  • Finerenone and cardiorenal outcomes by history of cardiovascular disease in patients with type 2 diabetes and chronic kidney disease: FIDELITY analyses.
  • Cardiovascular and kidney outcomes with finerenone in patients with type 2 diabetes and chronic kidney disease: the FIDELITY pooled analysis.
  • Chronic kidney disease in US adults with type 2 diabetes: an updated national estimate of prevalence based on Kidney Disease: Improving Global Outcomes (KDIGO) staging.

Stem and Root and Nutrileads Announce Launch of Daily Immunity for Optimized Immune Function Powered by BeniCaros for Ground Breaking Immunity Support

Retrieved on: 
Tuesday, March 15, 2022

Its first commercially available ingredient BeniCaros (cRG-I) is an award-winning, natural immune health ingredient derived from upcycled carrot pomace.

Key Points: 
  • Its first commercially available ingredient BeniCaros (cRG-I) is an award-winning, natural immune health ingredient derived from upcycled carrot pomace.
  • BeniCaros trains your immune system to be at its best when it matters the most.
  • At Stem & Root, we believe in the Power of Nature, Rooted in Science.
  • All Stem and Root products are backed by numerous ingredient clinical trials So, you can feel good about choosing Stem & Root.

Bayer Submits Applications in the U.S. and EU for Additional Indication of NUBEQA® (darolutamide)

Retrieved on: 
Wednesday, March 9, 2022

Bayer is seeking approval for the use of NUBEQA in combination with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Key Points: 
  • Bayer is seeking approval for the use of NUBEQA in combination with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
  • NUBEQA (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.
  • Effect of Other Drugs on NUBEQA Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity.
  • BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer.

Bayer and Direct Relief Work To Address Health Disparities, Expand Access to Family Planning Services through Community Awards Program

Retrieved on: 
Tuesday, March 8, 2022

The community award program is focused on expanding access to family planning services and contraception by addressing health disparities and pressing community needs in the US.

Key Points: 
  • The community award program is focused on expanding access to family planning services and contraception by addressing health disparities and pressing community needs in the US.
  • In 2020, Direct Relief identified four health clinics including Adagio Health (Pittsburgh, Pa.), Maternal and Family Health Services (Wilkes-Barre, Pa.), Planned Parenthood of Indiana and Kentucky (Indianapolis, Ind.
  • The funding reached more than 23,100 women through services, training, education, grants, and community outreach.
  • The community awards program is a three-year partnership with Direct Relief that helps address access through the donation of intrauterine devices (IUDs) by Bayer, grants administered by Direct Relief to health clinics around the country, and educational materials to healthcare facilities.

Positive Results from Phase III Investigational Trial Shows NUBEQA® (darolutamide) Plus Androgen Deprivation Therapy (ADT) and Docetaxel Significantly Increases Overall Survival (OS) in Patients with mHSPC

Retrieved on: 
Thursday, February 17, 2022

Results from the investigational Phase III ARASENS trial have shown that the use of oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) plus androgen deprivation therapy (ADT) and docetaxel significantly increased overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to ADT plus docetaxel.

Key Points: 
  • Results from the investigational Phase III ARASENS trial have shown that the use of oral androgen receptor inhibitor (ARi) NUBEQA (darolutamide) plus androgen deprivation therapy (ADT) and docetaxel significantly increased overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to ADT plus docetaxel.
  • NUBEQA plus ADT and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel (HR=0.68, 95% CI 0.57-0.80; P
  • ARASENS demonstrated that the addition of NUBEQA, an androgen receptor inhibitor, significantly increased overall survival for patients receiving standard androgen deprivation therapy and docetaxel as initial treatment for metastatic hormone-sensitive prostate cancer.
  • NUBEQA (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

Bayer Receives FDA Fast Track Designation for asundexian Stroke Program

Retrieved on: 
Thursday, February 10, 2022

Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke.

Key Points: 
  • Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke.
  • Fast Track Designation is intended to facilitate the development and expedite the review of drug candidates to treat serious medical conditions and fulfill unmet medical needs.
  • The purpose of the program is to get important new therapeutics to the patient earlier.
  • A drug candidate that receives Fast Track Designation may be eligible for more frequent interactions with the FDA to discuss the drug candidates development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.5
    We are pleased that asundexian has received Fast Track Designation from the FDA, underscoring the urgent need for additional effective therapies to treat secondary stroke prevention, said Hardi Mundl, M.D., group head thrombosis, clinical development and operations, Bayer.

Bayer and Mammoth Biosciences to Collaborate on Novel Gene Editing Technology

Retrieved on: 
Monday, January 10, 2022

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20220109005059/en/
    Mammoth Biosciences groundbreaking gene-editing technology is a key enabling technology, as well as a stand-alone therapeutic modality.
  • Were excited to be working together with Bayer, building on the technology leap of our novel CRISPR systems, along with Bayers expertise in successful drug development, said Dr. Peter Nell, Chief Business Officer and Head of Therapeutic Strategy at Mammoth.
  • Mammoth Biosciences proprietary toolkit of ultra-small Cas enzymes, including Cas14 and Cas, allows for expanded high-fidelity gene editing to be combined with targeted systemic delivery.
  • Under the agreement, Bayer gains access to this novel gene-editing technology, which offers the potential of an advanced in vivo applicability due to the ultra-compact size of these novel CRISPR systems.

Phase III Investigational Trial of NUBEQA® (darolutamide) in Combination with Docetaxel and Androgen Deprivation Therapy (ADT) Meets Primary Endpoint of Significantly Increasing Overall Survival (OS) in Patients with mHSPC

Retrieved on: 
Friday, December 3, 2021

In the ARASENS trial, NUBEQA in combination with docetaxel and androgen deprivation therapy (ADT) significantly increased overall survival (OS) compared to docetaxel and ADT.

Key Points: 
  • In the ARASENS trial, NUBEQA in combination with docetaxel and androgen deprivation therapy (ADT) significantly increased overall survival (OS) compared to docetaxel and ADT.
  • The ARANOTE trial (NCT04736199) is a randomized, double-blind, placebo-controlled Phase III study of NUBEQA in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC).
  • In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of NUBEQA orally twice daily or androgen deprivation therapy (ADT) alone.
  • NUBEQA (darolutamide) is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

Bayer Presented New Analyses Investigating KERENDIA® (finerenone) on Cardiovascular Outcomes in Patients With Chronic Kidney Disease Associated With Type 2 Diabetes

Retrieved on: 
Thursday, November 18, 2021

Finerenone reduces risk of incident heart failure in patients with chronic kidney disease and type 2 diabetes: analyses from the FIGARO-DKD trial.

Key Points: 
  • Finerenone reduces risk of incident heart failure in patients with chronic kidney disease and type 2 diabetes: analyses from the FIGARO-DKD trial.
  • Effect of finerenone on chronic kidney disease outcomes in type 2 diabetes.
  • Finerenone in mild to severe chronic kidney disease and type 2 diabetes: a FIDELITY subgroup analysis in patients with heart failure.
  • Chronic kidney disease in US adults with type 2 diabetes: an updated national estimate of prevalence based on Kidney Disease: Improving Global Outcomes (KDIGO) staging.

Bayer Wins U.S. Chamber of Commerce Foundation’s Annual Citizens Award

Retrieved on: 
Thursday, November 18, 2021

The U.S. Chamber of Commerce Foundation today awarded its Annual Citizens Award in the Best Health & Wellness category to Bayer U.S. for the companys industry leading efforts with Kits4Life, a program that repurposes non-used clinical trial supplies to help people in need.

Key Points: 
  • The U.S. Chamber of Commerce Foundation today awarded its Annual Citizens Award in the Best Health & Wellness category to Bayer U.S. for the companys industry leading efforts with Kits4Life, a program that repurposes non-used clinical trial supplies to help people in need.
  • The U.S. Chamber of Commerce Foundations Citizens Awards program recognizes the most innovative and impactful corporate citizenship initiatives raising the bar on social responsibility and accelerating momentum for a more resilient, inclusive, and sustainable future.
  • We are excited to be recognized by the U.S. Chamber of Commerce Foundation with this award.
  • The award was announced during the U.S. Chamber of Commerce Foundations 2021 Corporate Citizenship Conference, which explored how the private sector brings innovative solutions to societys most pressing challenges.