Rethinking Clinical Trials

FEBRUARY 14, 2024

Both drugs have a well-established safety profile and would be a good fit for a pragmatic design. The study started in June 2016 and ended in June 2022 and ultimately found no difference between the 2 drugs in preventing major CV outcomes and non-cancer death among hypertensive VA patients. 45% participants were from rural areas.

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XTalks

FEBRUARY 8, 2024

The top 15 diabetes drugs in 2023, according to 2022 sales data, reflect the current state of diabetes management and hint at the evolving needs and trends within this critical area of healthcare. Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics. mL subcutaneous solution (2 mg/1.5

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Velocity Clinical Research

NOVEMBER 21, 2023

“Without clinical research, there would be little if any development of new medicines,” says Isabelle Schenkenberger, MD. I’m proud and excited to be a part of it.” Dr. Schenkenberger is especially proud of her clinical trial research work in heart health, noting most new drugs never make it to market.

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XTalks

JUNE 26, 2023

has announced that its new drug-coated balloon (DCB) SurVeil has been granted approval by the US Food and Drug Administration (FDA). It represents a major milestone in our efforts to develop next-generation products to help millions of people affected by peripheral artery disease and the physicians that treat them.”

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FDA Law Blog

JUNE 2, 2022

James and Ellis will be participating in sessions covering key topic areas that our firm’s drug development client face on a daily basis: FDA and EMA Benefit-Risk Assessments: Can We Optimize and Is There an Enhanced Role for Sponsors and Patient Preferences? June 20, 4-5pm Central). More information can be found here.

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pharmaphorum

AUGUST 13, 2020

The cholesterol-lowering drug has been classed as a breakthrough therapy for homozygous familial hypercholesterolaemia (HoFH) by the FDA, which is due to deliver a decision on the marketing application by 11 February after a truncated six-month review. Analysts put peak US sales in the region of $200 million to $400 million.

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Drug Discovery World

NOVEMBER 25, 2022

A potential new drug to improve the long-term outcomes for heart attack patients will be trialled in the UK under a new agreement. . There are strong reasons to believe that this new drug may improve outcomes and this randomised blinded trial is the right way to test this theory.”.

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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.

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Drug Discovery World

AUGUST 7, 2023

The collaboration will work on developing exosome-encapsulated AAV (exoAAV) vectors as a novel gene delivery technology aimed at improving treatments for heart disease. Susmita Sahoo, Associate Professor of Medicine, Cardiology at Icahn Mount Sinai has been exploring the use of exosomes in gene therapy for several years.

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The Pharma Data

AUGUST 30, 2021

Metoprolol, a drug widely used to treat cardiovascular disease, is beneficial when administered to COVID-19patients. This is the finding of a study by investigators at the Centro Nacional de Investigaciones Cardiovasculares (CNIC), published today in the Journal of the American College of Cardiology (JACC).

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The Pharma Data

OCTOBER 14, 2020

15, 2020 /PRNewswire/ — Seattle Gummy Company’s breakthrough gummy drug program, which delivers Active Pharmaceutical Ingredients (APIs) in its innovative gummy matrix, recently won its first Investigational New Drug Application (IND) approval from FDA on the company’s allergy gummy medication, designated as IND 140312.

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XTalks

FEBRUARY 16, 2024

Eicos’ Aurlumyn (iloprost) received approval from the US Food and Drug Administration (FDA) for the treatment of severe frostbite, making it the first approved medication for the condition. People who have poor circulation and who don’t dress appropriately for the weather are at the highest risk of developing frostbite.

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pharmaphorum

JUNE 25, 2021

But Dr Craig Granowitz, chief scientific officer of cardiology drug developer Amarin, says that this is only the tip of the iceberg when it comes to the devastating impact of CVD on global populations. “In That’s a huge communication challenge. Think about that.

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Drug Discovery World

MAY 3, 2023

Patients with diabetes mellitus have an increased risk of cardiovascular events and endothelial dysfunction is an important factor for this development” said Jan Nilsson, Professor in Experimental Cardiology, Lund University, and principal investigator in the trial.

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Drug Discovery World

SEPTEMBER 1, 2022

Individuals with an autoimmune disorder have a substantially higher risk of developing cardiovascular disease, a large epidemiological study has revealed. . times depending on which autoimmune condition) of developing cardiovascular disease than people without an autoimmune disorder. . T argeted prevention measures needed.

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Medical Xpress

DECEMBER 7, 2022

Mann Department of Biomedical Engineering have developed a "heart attack on a chip," a device that could one day serve as a testbed to develop new heart drugs and even personalized medicines. Researchers at the University of Southern California Alfred E.

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Drug Discovery World

FEBRUARY 21, 2023

The research letter, ‘ Impact of Vaccination on Major Adverse Cardiovascular Events in Patients with COVID-19 Infection ,’ was published in the Journal of the American College of Cardiology. The post Covid-19 vaccination reduces risk of cardiac events appeared first on Drug Discovery World (DDW).

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Scienmag

NOVEMBER 13, 2020

Empagliflozin, a recently developed diabetes drug, can effectively treat and reverse heart failure in both diabetic and non-diabetic patients, according to researchers at the Icahn School of Medicine at Mount Sinai.

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Velocity Clinical Research

DECEMBER 6, 2023

In addition to being one of Poland’s top recruiting sites in cardiology trials, ClinMedica also recruits patients across a broad range of therapeutic areas involving ambulatory medicine. About Grzegorz Kania, MD Grzegorz Kania, MD specializes in cardiology as well as internal and family medicine. and Europe. and Europe.

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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.

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The Pharma Data

SEPTEMBER 29, 2021

Food and Drug Administration (FDA) supported the positive results of the FIDELIO-DKD phase III clinical trial study for patients with CKD and T2D. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development.

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pharmaphorum

OCTOBER 9, 2020

Shares in Amgen were down nearly 7% after close of trading yesterday after the company’s heart failure drug omecamtiv mecarbil disappointed in a large phase 3 trial. It is also hoping to steal market share from rivals with biosimilars, which are comparatively cheaper versions of biologic drugs.

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pharmaphorum

DECEMBER 21, 2020

Novartis’ cholesterol drug inclisiran has hit a speed bump with the FDA, which has rejected the potential blockbuster because a manufacturing facility has yet to be inspected. The European Commission has already approved the drug under the brand name Leqvio earlier this month following backing from the CHMP regulatory committee.

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pharmaphorum

APRIL 12, 2021

Hope that AstraZeneca’s diabetes and heart failure drug Farxiga might treat patients hospitalised with COVID-19 have been dashed after the drug failed to make an impact in a phase 3 trial. . Possible use of the drug to prevent infection with SARS-CoV-2 is also being explored.

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Scienmag

NOVEMBER 19, 2020

Approximately 60 percent of children born with congenital heart abnormalities will develop overt heart failure within […]. Credit: Mitsuhiko Yamada MD, PhD.,

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Delveinsight

DECEMBER 29, 2020

Myovant Sciences have decided to put their forces and efforts together to advance the Prostate cancer market as they announced their partnership deal to develop and market relugolix for prostate cancer and women’s health. . Welcome the First Generic of Drug for Severe Hypoglycemia. Billion Myovant/ Pfizer Deal. The post A USD 4.2

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) in January 2021 and was recommended for marketing authorization by the Committee for Medicinal Products for Human Use (CHMP) in the EU in May 2021. Vericiguat is being jointly developed with MSD (a tradename of Merck & Co., The vericiguat program is being co-developed by Bayer and MSD.

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XTalks

JULY 19, 2021

Phosphorus, a leading preventative genomics company, has developed the first comprehensive preventative genetic test for consumers. Phosphorus may be a familiar name as it was one of the first to develop an FDA-authorized at-home test for COVID-19 ; it was also the first test to have received an asymptomatic, direct-to-consumer FDA approval.

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XTalks

APRIL 15, 2021

Experts from Servier and Genuity Science recently spoke on a webinar about using genomics data to drive drug development in heart failure and identify new targets for novel therapeutics. However, these drugs have shown limited effectiveness in treating HFpEF. Watch this on-demand webinar to hear from these experts.

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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

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The Pharma Data

FEBRUARY 24, 2022

Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. Today, the U.S. Related Information.

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pharmaphorum

FEBRUARY 10, 2022

The FDA has granted fast-track status to Bayer’s oral Factor Xia inhibitor asundexian, which is in phase 2 testing as an anticoagulant that could offer safety advantages over current drugs. All three studies are looking at the drug on its own and in combination with anti-platelet therapies like aspirin and clopidogrel.

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The Pharma Data

NOVEMBER 11, 2021

Results from EMPEROR- Saved were presented at the European Society of Cardiology Congress 2021 and published in The New England Journal of Medicine. The FDA preliminarily granted Fast Track designation for the development of Jardiance to reduce the threat of cardiovascular death and hospitalization for heart failure.

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XTalks

FEBRUARY 6, 2024

Historically, Dr. Srivastava notes, CKD has often been considered a potential exclusion criterion for clinical trials due to apprehensions regarding the possibility of altered drug pharmacokinetics and the perceived risk of a worsened prognosis in patients with CKD. Director of Clinical Trial Management. Once this cycle starts, it’s a spiral.

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Scienmag

SEPTEMBER 29, 2020

Clues sought for why 1 in 5 pediatric cancer survivors develop heart failure Credit: UT Health San Antonio Cancer chemotherapy changes the function of cells that repair heart injury, researchers at The University of Texas Health Science Center at San Antonio (UT Health San Antonio) discovered.

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Drug Discovery World

JULY 31, 2023

DDW’s Reece Armstrong speaks to Hendrik Streefkerk , Chief Medical Officer and Drug Safety Officer of CellProthera about the company’s cell therapy for acute myocardial infarction (AMI) and why regenerative medicine could be key to treating cardiac diseases. So, hugely impactful.” References 1: [link] 2: [link] 3 : [link].

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XTalks

JULY 7, 2023

This substantial achievement paves the way for Milestone Pharmaceuticals to proceed with a New Drug Application (NDA) submission in late 2023. It occurs when a rapid, short-circuit rhythm develops in the heart’s upper chamber. One such drug is Adenosine, which was initially approved by the FDA in 1989.

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