Cardiology, Clinical Development and Development

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

Production

Production Clinical Development Development Regulation

Bayer extends clinical development program for finerenone with Phase III study in patients with non-diabetic chronic kidney disease

The Pharma Data

SEPTEMBER 29, 2021

The new FIND-CKD study extends our clinical research for finerenone to a non-diabetic population where the unmet need is high for brand spanking new treatments to delay disease progression.”. Bayer is committed to drive sustainable development and generate a positive impact with its businesses.

Clinical Development

Clinical Development Development Clinical Trials Clinical Trials

BridgeBio’s Attruby (Acoramidis): A New, More Potent TTR Stabilizer for ATTR-CM

XTalks

NOVEMBER 26, 2024

BridgeBio’s leadership, including Neil Kumar, emphasizes the significance of Attruby’s approval as a cornerstone in their mission to develop therapies for genetic diseases. Patient advocacy groups, including the Amyloidosis Support Groups led by Muriel Finkel, highlight the transformative impact of Attruby on the lives of those with ATTR-CM.

Genetic Disease

Genetic Disease Genetics Protein Clinical Development

Velocity Hosts Global CARE Council Summit

Velocity Clinical Research

MARCH 19, 2024

The summit focused on Velocity’s Diabetes + Obesity, MASH, Vaccine, Cardiology, and Women’s Health CARE Councils, along with a few areas in development.

Cardiology

Cardiology Clinical Trials Clinical Trials Clinical Development

Bayer extends clinical development program for finerenone with Phase II study investigating the initial combination therapy with empagliflozin in patients with chronic kidney disease and type 2 diabetes

The Pharma Data

FEBRUARY 24, 2022

Up to 40% of all patients with type 2 diabetes (T2D) develop CKD. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. It is estimated that CKD affects more than 160 million people with T2D worldwide.

Clinical Development

Clinical Development Development Cardiology Life Science

AstraZeneca to Acquire Alexion, Accelerating the Company’s Strategic and Financial Development

The Pharma Data

DECEMBER 12, 2020

Chief Executive Officer, Alexion , said: “For nearly 30 years Alexion has worked to develop and deliver transformative medicines to patients around the world with rare and devastating diseases. More recently, AstraZeneca has increased its efforts in immunology research and the development of medicines for immune-mediated diseases.

Development

Development Regulation Medicine Containment

Bayer delivers on medical innovation fueling transformation of pharma business

The Pharma Data

FEBRUARY 21, 2022

At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients. “We

Radiology

Radiology Cardiology Development Production

Novo Nordisk moves chronic kidney disease drug ziltivekimab into phase 3

pharmaphorum

MAY 18, 2021

Novo Nordisk has announced plans to move its ziltivekimab into phase 3 clinical development in atherosclerosis with chronic kidney disease after a mid-stage trial met its main goal. Data were announced at the virtual American College of Cardiology annual conference and published simultaneously in The Lancet.

Drugs

Drugs Cardiology Trials Clinical Trials

Pfizer Completes Acquisition of Arena Pharmaceuticals

The Pharma Data

MARCH 13, 2022

(NYSE: PFE) announced today the completion of its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Additional Transaction Details. .:

Dermatology

Dermatology Cardiology Development Medicine

Cardiol Therapeutics Announces Formation of Data Safety Monitoring and Clinical Endpoint Committees for Phase II/III Outcomes Trial in High-Risk Patients Hospitalized with COVID-19

The Pharma Data

JANUARY 20, 2021

After each data review, the DSMC will advise the study Steering Committee with recommendations for protocol modifications, if concerns over safety have developed, or that the study should continue according to the protocol if no concerns are identified. About Cardiol Therapeutics. Cardiol Therapeutics Inc. ( alone exceeding $30 billion.

Trials

Trials Cardiology Containment Development

Cardiac Biomarkers in Cardiovascular Clinical Trials: Caveats and Considerations

XTalks

NOVEMBER 19, 2021

While cardiac biomarkers hold much promise, there are a number of challenges in developing robust markers that can accurately reflect changes in disease biology linked to the mechanism of action of a therapeutic intervention. This is a part of the precision cardiology approach and could lead to their use as prognostic indicators.

Clinical Trials

Clinical Trials Clinical Trials Trials In-Vitro

New Phase III study to investigate expanded use of vericiguat in patients with chronic heart failure with reduced ejection fraction

The Pharma Data

NOVEMBER 11, 2021

Bayer and its development mate MSD moment blazoned the launch of VICTOR (VerICiguaT in grown-ups with Habitual heart failure and Reduced ejection bit), a new Phase III cardiovascular study probing the expanded use of heart failure (HF) treatment vericiguat. The vericiguat program is beingco-developed by Bayer and MSD.

Cardiology

Cardiology Branding Development Production

BlueRock Therapeutics Announces Completion of Enrollment of Phase 1 Trial in Patients with Parkinson’s Disease

The Pharma Data

MAY 31, 2022

Senior Vice President, Clinical Development, BlueRock Therapeutics. “We We are excited that our Phase 1 clinical trial has completed enrollment and believe it is a critical next step toward the development of a novel cell therapy that has the potential to transform the treatment landscape for this devastating disease.”.

Trials

Trials Engineer Clinical Trials Clinical Trials

U.S. FDA approves finerenone for the treatment of patients with chronic kidney disease associated with type 2 diabetes

The Pharma Data

JULY 12, 2021

Up to 40% of all patients with type 2 diabetes develop chronic kidney disease. The clinical data from FIGARO-DKD are scheduled for presentation at the European Society of Cardiology (ESC) Congress 2021 on August 28th. Up to 40% of all patients with type 2 diabetes develop CKD. The study met its primary endpoint.

FDA Approval

FDA Approval Cardiology Medicine Trials

RHYTHM AI cleared for large trial of atrial fibrillation mapping tool

pharmaphorum

OCTOBER 8, 2020

Clinical development of the system got off the ground last year when the company announced the closure of a £2.15m financing round. Developed at the city’s St Bartholomew’s Hospital, the system was developed by a team including London-based cardiologist Richard Schilling.

Trials

Trials Clinical Trials Clinical Trials Clinical Development

Jardiance® shows consistent cardio-renal benefits in adults with heart failure with left ventricular ejection fraction over 40% regardless of chronic kidney disease status

The Pharma Data

NOVEMBER 5, 2021

EMPEROR Program clinical investigator and Emeritus Professor of Rectifiers and Cardiology at the University of Lorraine, France.”The vice chairman, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals,Inc.”The ” TheU.S. .”We

Trials

Trials Cardiology Drugs Development

New data from finerenone clinical trial program reinforces renal and cardiovascular benefits in patients with CKD and T2D independent of baseline therapy

The Pharma Data

NOVEMBER 8, 2021

The cardiology ballot at Bayer formerly includes a number of products and several other composites in colorful stages of preclinical and clinical development. Bayer is committed to drive sustainable development and induce a positive impact with its businesses.

Clinical Trials

Clinical Trials Clinical Trials Trials HR

Unveiling Potential: Exploring Alpha Emitter Radiopharmaceuticals

XTalks

JANUARY 19, 2024

Regulatory bodies have demonstrated preparedness for the surge in radiopharmaceuticals as evidenced by inaugural Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) programs to expedite commercial manufacturing, US Food and Drug Administration (FDA) approvals and marketing authorizations.

DNA

DNA Radiology FDA Approval Development

New Data on Finerenone for the protection of patients with.

The Pharma Data

AUGUST 30, 2021

Professor of Cardiology at the National and Kapodistrian University of Athens, Greece, and co-principal investigator of the FIDELIO-DKD and FIGARO-DKD Phase III clinical trials. Up to 40% of all patients with type 2 diabetes develop chronic kidney disease.

HR

HR Cardiology Clinical Trials Clinical Trials

Bayer to present new data from comprehensive finerenone clinical trial program

The Pharma Data

OCTOBER 28, 2021

The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. Bayer is committed to drive sustainable development and generate a positive impact with its businesses.

Clinical Trials

Clinical Trials Clinical Trials Trials Branding

FDA grants Jardiance® Breakthrough Therapy designation for heart failure with.

The Pharma Data

SEPTEMBER 11, 2021

Results from EMPEROR-Preserved were presented at the European Society of Cardiology Congress 2021 on August 27 and published in The New England Journal of Medicine. vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc.

Medicine

Medicine Insulin FDA Approval Trials

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

The Pharma Data

SEPTEMBER 15, 2020

(NYSE: PFE) provided an extensive overview of pipeline advances and shared updates on the Company’s efforts to battle the COVID-19 pandemic on multiple fronts, including new data on the BNT162b2 vaccine candidate being developed in collaboration with BioNTech SE. UPDATES ON COVID-19 DEVELOPMENT PROGRAMS. and -50.4%

Gene Therapy

Gene Therapy Vaccination Vaccine Trials

Breakthrough results for Jardiance® (empagliflozin) confirm EMPEROR-Preserved as first and only successful trial for heart failure with preserved ejection fraction

The Pharma Data

JULY 8, 2021

. “No approved therapies have been clinically proven to improve outcomes specifically for people with HFpEF, leaving a significant unmet medical need in this already prevalent and increasingly common form of heart failure,” said Mohamed Eid, M.D., vice president, Product Development, Lilly. Va ginal yeast infection.

Trials

Trials Doctors Doctor Medicine

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

XTalks

AUGUST 2, 2023

is a global pharmaceutical company, working across both developed and emerging markets. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities. Pfizer Inc.

Sales

Sales Manufacturing FDA Approval Life Science

Women’s Health Clinical Trials: Clinical Innovations, Opportunities and Considerations

XTalks

SEPTEMBER 11, 2024

Jansen recently moderated a webinar in which her colleagues at Medpace discussed the evolving women’s health sector, including the historical challenges and emerging trends in clinical development. This includes developing new therapies and improving existing ones for chronic conditions long neglected.

Clinical Trials

Clinical Trials Clinical Trials Trials Hormones

BlueRock secures FDA fast track; Omniscient rakes in $29M; Neuspera’s nerve implant gets a $65M boost Rivus’ therapy nabs $35M

Delveinsight

JULY 22, 2021

Joachim Fruebis, chief development officer of BlueRock, said that receiving fast track designation from the FDA is a crucial step, which will help them further progress clinical development of their DA01 cell therapy approach for Parkinson’s disease.

Cardiology

Cardiology Development Engineer Clinical Trials

Merck Announces Retirement of Dr. Roy D. Baynes; Dr. Eliav Barr Appointed Head of Global Clinical Development and Chief Medical Officer

The Pharma Data

MARCH 23, 2022

Baynes, head of Global Clinical Development (GCD) and Chief Medical Officer, Merck Research Laboratories (MRL), will be retiring from Merck in July. He also led the expansion of Merck’s research and development in China and Japan. “It Eliav Barr, senior vice president, Global Clinical Development.

Clinical Development

Clinical Development Development Vaccination Vaccine

Vericiguat approved in Japan to treat patients with chronic heart failure

The Pharma Data

JUNE 28, 2021

Vericiguat is being jointly developed with MSD (a tradename of Merck & Co., The vericiguat program is being co-developed by Bayer and MSD. The companies share equally the costs of the development of vericiguat. Kenilworth, NJ, USA). About Vericiguat Vericiguat 2.5 MSD has the commercial rights to vericiguat in the U.S.

Cardiology

Cardiology Production Development Medicine

Clinical Research Informer

Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

Bayer extends clinical development program for finerenone with Phase III study in patients with non-diabetic chronic kidney disease

Trending Sources

BridgeBio’s Attruby (Acoramidis): A New, More Potent TTR Stabilizer for ATTR-CM

Velocity Hosts Global CARE Council Summit

Bayer extends clinical development program for finerenone with Phase II study investigating the initial combination therapy with empagliflozin in patients with chronic kidney disease and type 2 diabetes

AstraZeneca to Acquire Alexion, Accelerating the Company’s Strategic and Financial Development

Bayer delivers on medical innovation fueling transformation of pharma business

Novo Nordisk moves chronic kidney disease drug ziltivekimab into phase 3

Pfizer Completes Acquisition of Arena Pharmaceuticals

Cardiol Therapeutics Announces Formation of Data Safety Monitoring and Clinical Endpoint Committees for Phase II/III Outcomes Trial in High-Risk Patients Hospitalized with COVID-19

Cardiac Biomarkers in Cardiovascular Clinical Trials: Caveats and Considerations

New Phase III study to investigate expanded use of vericiguat in patients with chronic heart failure with reduced ejection fraction

BlueRock Therapeutics Announces Completion of Enrollment of Phase 1 Trial in Patients with Parkinson’s Disease

U.S. FDA approves finerenone for the treatment of patients with chronic kidney disease associated with type 2 diabetes

RHYTHM AI cleared for large trial of atrial fibrillation mapping tool

Jardiance® shows consistent cardio-renal benefits in adults with heart failure with left ventricular ejection fraction over 40% regardless of chronic kidney disease status

New data from finerenone clinical trial program reinforces renal and cardiovascular benefits in patients with CKD and T2D independent of baseline therapy

Unveiling Potential: Exploring Alpha Emitter Radiopharmaceuticals

New Data on Finerenone for the protection of patients with.

Bayer to present new data from comprehensive finerenone clinical trial program

FDA grants Jardiance® Breakthrough Therapy designation for heart failure with.

Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas

Breakthrough results for Jardiance® (empagliflozin) confirm EMPEROR-Preserved as first and only successful trial for heart failure with preserved ejection fraction

Top 30 Pharma and Biotech Companies in 2023: Statistics and Trends

Women’s Health Clinical Trials: Clinical Innovations, Opportunities and Considerations

BlueRock secures FDA fast track; Omniscient rakes in $29M; Neuspera’s nerve implant gets a $65M boost Rivus’ therapy nabs $35M

Merck Announces Retirement of Dr. Roy D. Baynes; Dr. Eliav Barr Appointed Head of Global Clinical Development and Chief Medical Officer

Vericiguat approved in Japan to treat patients with chronic heart failure

Stay Connected