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The pharmaceutical company currently has several promising treatments in development for gastroenterological, dermatological, and cardiological conditions.
For instance, in the LIBerate-HeFH trial in patients with HeFH, the treatment led to mean placebo-adjusted LDL-C reductions of 65% at 24 weeks, with approximately 68% of patients achieving LDL-C reductions of 50% or more, meeting European Society of Cardiology guideline-recommended targets.
Two single-country trials and 44 multinational investigations with a site in Ukraine have started over the past six months, according to Global Data, with research covering infectious diseases, cardiology, schizophrenia, and gastrointestinal therapies. Using technology and decentralisation has also contributed.
According to a new article in Cardiovascular Innovations and Applications, sodium-glucose cotransporter-2 (SGLT2) inhibitors have been found to ameliorate major adverse cardiovascular events in patients with heart failure with preserved ejection fraction (HFpEF), but the exact mechanism is unknown.
Team of researchers studies how oxidative stress influences the elasticity of the heart muscle Credit: Linke Lab A healthy heart beats 50 to 100 times a minute and pumps 8,000 litres of blood around our body every day. A precondition for this function is the elasticity of the cardiac walls, which dilate as blood flows […].
Authors from the German Center for Diabetes Research (DZD) presented data showing that the longevity gene mammalian Indy (mINDY) is involved in blood pressure regulation in the Journal of Clinical Investigation (JCI) insight.
The key lies in personalization, strategic segmentation, and strict adherence to industry regulations. Regulatory-Friendly Communication : Unlike social media ads, emails offer controlled messaging that aligns with compliance regulations. oncology, diabetes, cardiology). Therapeutic area focus (e.g.,
A new study led by investigators from Brigham and Women's Hospital, a founding member of the Mass General Brigham healthcare system, analyzed the cerebral blood flow (CBF) regulation of individuals who had experienced strokes.
Unlike CETP inhibitors, PCSK9 inhibitors block a protein that regulates cholesterol levels. Amgens Repatha (evolocumab) and Novartis Leqvio (inclisiran) are injectable proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors, with Leqvio offering a twice-yearly injection option.
According to a new study published in The American Journal of Human Genetics, more than one third of genetic variants that increase the risk of coronary artery disease regulate the expression of genes in the liver. These variants have an impact on the expression of genes regulating cholesterol metabolism, among other things. […].
The Australian biotech sifted through the data however and found that some patients in the study had a 60% reduction in the incidence of heart attacks or strokes, which it thinks may be enough to file for approval, although that will depend on negotiations with regulators. Other readouts give grounds for optimism.
When NO binds to sGC, the enzyme catalyzes the synthesis of intracellular cyclic guanosine monophosphate (cGMP), a second messenger that plays a role in the regulation of vascular tone, cardiac contractility, and cardiac remodeling. About Vericiguat Vericiguat 2.5 MSD has the commercial rights to vericiguat in the U.S.
This meeting brings together industry, regulators, academics, and patients to discuss global and local challenges in the life sciences industry. Hyman, Phelps & McNamara, P.C.’s s James Valentine and Ellis Unger will be presenting at the DIA 2022 Global Annual Meeting held this June 19-23 in Chicago, IL.
While at FDA, Dr. Unger’s Office oversaw the approval and regulation of scores of new drugs for cardiovascular, renal, neurological, and psychiatric disorders. He completed his cardiology training at The Johns Hopkins Hospital in 1987.
The decision gave Bayer complete control of BlueRock’s cell therapy pipeline, headed by DA01 and spanning various diseases in the neurology , cardiology , and immunology categories. CMAs work as a new approach to stimulate mitochondrial uncoupling, a natural process in the body that regulates and dissipates energy.
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The US regulator issued Novartis with a complete response letter (CRL) for inclisiran in December, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy.
Asundexian (also known as BAY2433334) will be given a speedy review by the US regulator as a secondary preventative treatment for people with ischaemic stroke, specifically those with non- cardioembolic risk factors like narrowed arteries.
It plays a crucial role in many inflammatory and autoimmune diseases across multiple therapy areas, including haematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. Any failure to comply with this restriction may constitute a violation of such laws or regulations. Morgan Cazenove) (“J.P.
“Who would have predicted that the public might ever think CBD is a cardiology medication?” CBD isn’t regulated by the FDA, meaning that the purity and dosage of any particular product has not been tested, the researchers added. ” Smith is chief of infectious diseases and global public health at the university.
Creating content that is informative, engaging, and compliant with industry regulations. Scientific blogs discussing new advancements in oncology, cardiology, or rare diseases. It helps educate HCPs and patients, build trust, and improve engagement while ensuring compliance with industry regulations.
Michael Felker, MD, MHS, FACC, FAHA, FHFSA is Professor of Medicine with tenure in the Division of Cardiology at Duke University School of Medicine. He is Director of Cardiovascular Research at the Duke Clinical Research Institute and Vice-Chief for Clinical Research in the Division of Cardiology. About Dr. Udelson
James E.
Xtalks spoke with Kaushik Gune, Head of Healthcare (US) at Huma, a global digital health technology company, to learn more about SaMD and what it looks like to create a regulated health app. What are some examples of software as a medical device (SaMD) and how is this software regulated? Tier one devices represent the low risk.
Treatment options like it not only have the potential to improve patient care but also to influence future research directions and treatment strategies in interventional cardiology.
Tryngolza works by targeting a protein in the liver, apoC-III, which regulates triglyceride metabolism. People with FCS often have triglyceride levels higher than 880 mg/dL, compared to a healthy target level of below 150 mg/dL. FCS also severely impacts quality of life, causing chronic fatigue and recurrent stomach pain.
Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . The post UK regulator backs Amarin’s cardiology drug Vazkepa appeared first on. Icosapent ethyl also demonstrated a 26% relative risk reduction and a 3.6%
Mackey says that the global regulations surrounding the issue are still lagging compared to the speed at which the issue is growing. “I The FDA has flagged this issue as pharmacies selling prescription drugs illegally have proliferated over the years.
Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders, cardiology and ophthalmology. This press release and further information about Alexion can be found at: www.alexion.com.
FDA regulations that establish the criteria for electronic records and electronic signatures. eCRFs can be tailored to meet the specific needs of different therapeutic areas by: Custom Data Fields: Creating data fields that are relevant to the specific therapeutic area, such as oncology or cardiology.
It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. It can be used as a monotherapy or along with cholesterol-lowering medicines.
Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on hematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. This press release and further information about Alexion can be found at: www.alexion.com. .;
The drugmaker was supposed to hear back from the FDA on mavacamten at the end of January, but the regulator delayed its deadline to 28 April to allow more time to look at BMS’ risk evaluation and mitigation strategy (REMS) for the drug, which is vying to become the first cardiac myosin inhibitor on the market.
This is a part of the precision cardiology approach and could lead to their use as prognostic indicators. The Double-Edged Sword of Cardiac Biomarkers. A Functional Future State. This also means beginning to look at cardiac biomarkers critically earlier during the trial process.
The European Commission has become the first regulator to approved Jardiance (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), also known as systolic heart failure.
Diet has been shown to play a role in regulating inflammation, which is associated with many chronic illnesses, including heart disease. “This is a reminder that diet is important. The only surprise to me was the magnitude of the effect.” According to AHA statistics, an estimated 6.2 million U.S.
When NO binds to sGC, the enzyme catalyses the conflation of intracellular cyclic guanosine monophosphate (cGMP), a alternate runner that plays a part in the regulation of vascular tone, cardiac contractility, and cardiac redoing. About Vericiguat Vericiguat2.5 MSD has the marketable rights to vericiguat in theU.S.
The US regulator is looking at data from the EMPEROR-Reduced trial of Jardiance (empagliflozin), which found that the drug achieved a 25% reduction in the combined primary endpoint of cardiovascular death or hospitalisation compared to placebo.
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Now, detailed findings presented at the European Society of Cardiology (ESC) meeting over the weekend showed just how well the drug performed, and have the potential to “transform the standard of care” in patients with CKD, according to the trial investigators.
Boston Scientific has issued an urgent recall of some of its Accolade pacemakers following reports of malfunctions that have been tied to two patient deaths. The company said the recall affects a subset of Accolade pacemakers, which include Proponent, Essentio and Altrua 2 dual chamber (DR) standard life (SL) and R extended life (EL) pacemakers.
Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on hematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. This press release and further information about Alexion can be found at: www.alexion.com.
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