Search Results for “cardiovascular” – Page 36 – media

Complications, pathophysiology, and treatment of type 2 diabetes differ by sex

In a recent review published in the journal Diabetologia, researchers in Austria discussed the sex-based differences in the risk factors, diagnosis, and therapeutic approaches for type 2 diabetes and associated complications to improve awareness about and management options for all diabetes type 2 patients. Background Studies show that patterns associated with type 2 diabetes vary according to sex, with the prevalence of the disease being higher among the young to middle-aged male population but the increase in postprandial glucose levels being higher among women and increasing with age. Furthermore, the varying clinical outcomes based on sex depend on the influence of hormonal and genetic factors on the diagnoses, therapeutic response, clinical outcomes, and pathophysiology. Therefore, because of the varying levels of sex hormones, the risk of type 2 diabetes and other cardiometabolic diseases also varies significantly for women. Additionally, substantial sex-based differences in lifestyles, behaviors, and approaches ...
- Source: drugdu
- 152
- March 28, 2023
Novartis Receives FDA Approval for New Heart Failure Drug

Novartis, a global pharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for its new heart failure drug, called Entresto XR. This approval expands the use of the company’s existing heart failure drug, Entresto, by making it available in an extended-release form. Heart failure is a chronic condition in which the heart is unable to pump enough blood to meet the body’s needs. It affects millions of people worldwide and is a leading cause of hospitalization and death. Entresto XR is a once-daily tablet that combines two medications, sacubitril and valsartan, to reduce the strain on the heart and improve its ability to pump blood. The FDA’s approval of Entresto XR was based on the results of a clinical trial that involved over 5,000 patients with heart failure. The trial showed that Entresto XR was superior to the standard of care, enalapril, in ...
- Source: drugdu
- 251
- March 22, 2023
Bayer’s Kerendia approved in the US to slow CKD in type 2 diabetes patients

Bayer’s first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) Kerendia has received approval in the US to slow chronic kidney disease (CKD) progression in patients with type 2 diabetes (T2D). The US Food and Drug Administration (FDA) has cleared Kerendia (finerenone) to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction (MI) and hospitalisation for heart failure in adult patients with CKD associated with T2D. The approval is based on data from the Phase III FIDELIO-DKD renal outcomes study, which showed Kerendia significantly reduced the combined primary endpoint of chronic kidney disease progression, kidney failure or kidney death versus placebo when added to standard of care. The drug also lowered the risk of a composite of time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke or heart failure hospitalisation, thereby by also meeting secondary targets. “Kerendia is the first and only nonsteroidal mineralocorticoid receptor ...
- Source: drugdu
- 1,036
- August 26, 2021
diabetes
FDA nod for Kiniksa’s Arcalyst in recurrent pericarditis

The US Food and Drug Administration (FDA) has approved Kiniksa Pharmaceuticals’ interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) inhibitor Arcalyst (rilonacept) for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older. Recurrent pericarditis is an autoinflammatory cardiovascular disease that often presents with chest pain, and is associated with changes in electrical conduction and build-up of fluid around the heart. The FDA approval is based on positive data from the RHAPSODY trial in recurrent pericarditis. Data from this trial showed that Arcalyst treatment improved clinically meaningful outcomes associated with the significant unmet medical need in recurrent pericarditis. There were rapid and sustained reductions in both reported pain and inflammation as early as after the first dose of Arcalyst. “The approval of Arcalyst in recurrent pericarditis is an extremely important achievement for those suffering from this disease as there can be significant ...
- Source: drugdu
- 197
- March 23, 2021
Kiniksa
UK approval for Daiichi Sankyo’s cholesterol-lowering treatments

Daiichi Sankyo’s cholesterol-lowering drugs Nilemdo and Nustendi have been approved by the UK National Institute for Health and Care Excellence (NICE) for use on the NHS. Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/ezetimibe) have been recommended for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia (heterozygous familial and non-familial). It is authorised as an adjunct to diet and when statins are contraindicated or not tolerated, or when the standard cholesterol treatment ezetimibe alone does not control low-density lipoprotein cholesterol (LDL-C) adequately. “Today’s decision is a landmark step forward for patients and the NHS in working towards a national ambition of preventing cardiovascular disease and events in line with the Long Term Plan,” said Manuel Reiberg, managing director, Daiichi Sankyo UK. “We are now more dedicated than ever to reduce the impacts of the UK’s biggest killer through our ongoing collaboration with the medical community and the NHS,” he added. In the UK, ...
- Source: drugdu
- 212
- March 19, 2021
cholesterol-lowering
Janssen buys rights to Hemera’s eye disease gene therapy candidate

3rd December 2020 Johnson & Johnson’s pharmaceuticals division Janssen has purchased rights to acquire an investigational gene therapy asset for geographic atrophy from Hemera Biosciences. Geographic atrophy is an advance and severe form of age-related macular degeneration (AMD) which affects five million people globally. Hemera’s investigational gene therapy, HMR59, is administered as a one-time intravitreal injection to aid vision preservation in patients with geographic atrophy. HMR59 is designed to increase the ability of retina cells to produce a soluble form of CD59, a protein that protects the retina from damage. Patients with wet AMD often have low levels of this protein, which is an essential component of the body’s natural immune response. “Geographic atrophy is a devastating form of AMD that impacts the ability to accomplish everyday tasks, such as reading, driving, cooking, or even seeing faces,” said James List, global therapeutic area head, cardiovascular & metabolism, Janssen Research & ...
- Source: drugdu
- 298
- December 9, 2020
Gene therapy
Enhertu granted Priority Review in the US for the treatment of HER2-positive metastatic gastric cancer

Only HER2-directed medicine to demonstrate significant improvement in overall survival compared to chemotherapy for previously treated patients in this setting AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has received acceptance for its supplemental Biologics License Application (sBLA) and has also been granted Priority Review in the US for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that offer significant advances over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, will be during the first quarter of 2021. There are more than 27,000 new cases of gastric cancer in the US each year, of which approximately one in five are HER2 positive.1,2 For patients with metastatic gastric cancer who progress ...
- Source: drugdu
- 318
- November 4, 2020
gastric cancer
Autoantibody order, timing predict genetically at-risk children most likely to get type 1 diabetes

by University of South Florida Children with multiple islet autoantibodies—biological markers of autoimmunity—are more likely to progress to symptomatic type 1 diabetes (T1D) than those who remain positive for a single autoantibody. Now, new findings from The Environmental Determinants of Diabetes in the Young (TEDDY) study in the U.S. and Europe show that detailed information about the order, timing and type of autoantibodies appearing after the first autoantibody can significantly improve prediction of which children are most likely to progress to type 1 diabetes more rapidly. The TEDDY analysis was published in the September 2020 issue of Diabetes Care. “A better understanding of distinct autoantibody spreading is important, because it will allow us to identify at-risk children earlier in the disease process,” said the study’s lead author Kendra Vehik, Ph.D., a professor of epidemiology at the University of South Florida Health (USF Health) Morsani College of Medicine’s Health Informatics ...
- Source: drugdu
- 521
- October 30, 2020
diabetes
AZ’s Farxiga Gets FDA Priority Review For Heart Failure

AstraZeneca has got off to a strong start in 2020, with the FDA granting a fast review for its diabetes drug Farxiga in heart failure and China approving Lokelma for hyperkalemia.
- Source: https://scrip.pharmaintelligence.informa.com/SC141424/AZs-Farxiga-Gets-FDA-Priority-Review-For-Heart-Failure
- 1,412
- January 8, 2020
AstraZeneca Farxiga FDA Lokelma
What were the top findings?

Another busy year for clinical research has come and gone. What are the most important findings from 2019? Here is our overview of some of the most noteworthy studies of the year.What happened in medical research in 2019? In this special feature, we summarize this year’s top findings. “Medicine is of all the Arts the most noble,” wrote the Ancient Greek physician Hippocrates — whom historians call the “father of medicine” — over 2,000 years ago. Advances in therapeutic practices have been helping people cure and manage illness since before the time of Hippocrates, and, today, researchers continue to look for ways of eradicating diseases and improving our well-being and quality of life.Each year, specialists in all areas of medical research conduct new studies and clinical trials that bring us a better understanding of what keeps us happy and in good health, and what factors have the opposite effect. And, ...
- Source: drugdu
- 290
- December 23, 2019

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