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LONDON — Novo Nordisk’s diabetes medication Ozempic cut the risk of patients developing advanced kidney disease or dying from kidney or heart complications, the company said Tuesday, adding to the evidence the wildly popular drug has broader health benefits for patients beyond addressing their diabetes. and Europe.
Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the first quarter: In December, Vertex Pharmaceuticals announced results from a mid-stage clinical trial showing its experimental, non-opioid drug reduced pain in people with diabetes who have chronic pain.
NEW YORK — Glucose tracking is the future, Dexcom executives gushed at a glitzy launch event for their new, over-the-counter continuous glucose monitor on Wednesday evening. Over the past 25 years, continuous glucose monitors have changed the shape of diabetes care.
Rybelsus (oral semaglutide) significantly reduced the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and cardiovascular disease (CVD) and/or chronic kidney disease (CKD).
In the final year of World War II, Nazi troops starved the Netherlands in a brutal event known as the Dutch Hunger Winter. The survivors went on to have children and even grandchildren with increased rates of metabolic issues like diabetes, hypertension, and schizophrenia.
The study looked into two cohorts of patients without active heart disease, 60% of whom were treated with statins, and found a strong association between a metabolic product of excess niacin and an increased risk of major adverse cardiovascular events such as a heart attack or stroke. Read the rest…
The US FDA has approved Novo Nordisk’s Ozempic for reducing the risk of kidney failure and disease progression, as well as death due to heart problems in diabetes patients with chronic kidney disease (CKD), the Danish drugmaker said on Tuesday.
A turbulent series of events surrounding the supply of Eli Lilly’s blockbuster weight loss treatment has raised concerns around how the Food and Drug Administration maintains its list of drug shortages and which sources it relies on, an issue that affects a growing number of Americans.
On Thursday, at a press briefing at which they presented their 2023 earnings, AstraZeneca executives also played coy about the bargaining over the price of the company’s diabetes drug Farxiga. “We are in active negotiation, and it will be a few rounds of discussions” with Medicare.
A turbulent series of events surrounding the supply of Eli Lilly’s blockbuster weight loss treatment has raised concerns around how the Food and Drug Administration maintains its list of drug shortages and which sources it relies on, an issue that affects a growing number of Americans.
In late May, the Food and Drug Administration said it received a “few” adverse event reports concerning compounded versions of the injectable medicines, which both contain the same active ingredient, known as semaglutide. The notice raised an important question: To what extent should the public be concerned?
Diabetes drug semaglutide, marketed as Wegovy, could also reduce risk of cardiovascular events by 20%, its manufacturer has claimed. Novo Nordisk has announced headline findings from its SELECT trial, although they have not yet been published in a peer-reviewed journal.
TZIELD (teplizumab-mzwv) has demonstrated TZIELD’s potential to slow disease progression in newly diagnosed children and adolescents with Stage 3 type 1 diabetes. HbA1c reductions and the overall rates of clinically important hypoglycemic events were similar among both study groups. As the primary endpoint, 94.9
November is American Diabetes Month – a time to come together to spread awareness about diabetes prevention and management. In this blog post, we’ll explore key ways pharmacies can actively participate in American Diabetes Month.
The type 2 diabetes (T2D) landscape has historically been dominated by insulin receptor (IR) targeting drugs. This condition disrupts glucose metabolism, resulting in high blood glucose levels and a variety of effects thereafter, such as an increased risk of stroke and diabetic neuropathy. IR’s role in T2D is well-defined.
A thyroid cancer safety signal was raised by the European Medicines Agency last month over several Novo Nordisk drugs, including semaglutide, which is used in popular diabetes and obesity drugs Ozempic and Wegovy , Reuters notes. The A signal from the EMA does not mean that the medicine is the cause of any reported adverse events.
Food and Drug Administration is evaluating reports of side effects such as hair loss and suicidal thoughts in people taking medications known as GLP-1 receptor agonists, which are approved to treat diabetes or weight loss , CNN reports. These include Ozempic, Rybelsus, Wegovy, Saxenda, Victoza, Mounjaro, and Zepbound.
Bayer’s big investment in time and money on the development of finerenone for chronic kidney disease (CKD) in diabetics has paid off with an FDA approval, although it could face stiff competition in the market. . The post Bayer’s finerenone gets FDA nod for diabetic kidney disease appeared first on.
In the SOUL trial, Rybelsus produced a 14% risk reduction of major adverse cardiovascular events in patients with type 2 diabetes and cardiovascular disease and/or chronic kidney disease.
Lonza and Vertex Pharmaceuticals Incorporated have agreed to collaborate to support the manufacture of Vertex’s Type 1 diabetes cell therapy portfolio. Participants with greater than 90 days of follow-up had elimination of severe hypoglycaemic events in the evaluation period.
The European Medicines Agency backed the use of Novo Nordisk’s Wegovy to lower major heart risks and strokes in overweight or obese adults without diabetes , Reuters notes. Food and Drug Administration approved the drug for prevention of cardiovascular events in people with obesity earlier this year.
The US Food and Drug Administration (FDA) has approved Provention Bio’s biologics licence application (BLA) for Tzield (teplizumab-mzwv) to treat type 1 diabetes (T1D) patients. The post US FDA approves Provention Bio’s Tzield to delay diabetes appeared first on Pharmaceutical Technology.
In recognition of American Diabetes Month , the growing need for effective, accessible and patient-centered diabetes care is emphasized. Approximately 38 million Americans live with diabetes, a condition requiring multiple medications, lifestyle adjustments and frequent monitoring to prevent serious complications. As the U.S.
Stempeutics Research recently completed enrollment in the Phase 3 clinical trial evaluating a single peri-ulcer injection of its proprietary allogeneic mesenchymal stromal cell product candidate Stempeucel-DFU in patients with non-healing diabetic foot ulcer. Phase 3 trial has been approved by DCGI.
Results from the DREAM-HF trial showed that Revascor reduced cardiovascular mortality and major adverse cardiovascular events and improved left ventricular function in high-risk HF patients. However, regenerative therapies come with high price tags and may struggle to gain market share against substantially cheaper, generic drugs.
A new post-hoc analysis from Novo Nordisk of their SUSTAIN 6 and PIONEER 6 studies into semaglutide is looking to help ‘individualise’ treatment for diabetes patients by better predicting their cardiovascular lifetime risk. The two studies included 6,480 people with type 2 diabetes with high cardiovascular risk aged between 50-90 years.
We plan to catch up on sundry tasks, promenade with the official mascots and escort Mrs. Pharmalot to an event or two. This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda has possibilities. And what about you? This remains a fine time to enjoy the great outdoors. Well, whatever you do, have a grand time.
Eli Lilly’s decision to throw large amounts of research dollars at its next-generation diabetes drug tirzepatide could be vindicated, according to its first phase 3 trial readout. More than half (51.7%) of participants in the treatment arm achieved an A1C less than 5.7% – the level seen in people without diabetes.
Bayer has claimed EU approval for Kerendia, its new drug for chronic kidney disease (CKD) in people with type 2 diabetes, as the company tries to build a role of the drug alongside rival therapies from AstraZeneca and Johnson & Johnson.
Novo Nordisk’s GLP-1 agonist Ozempic has shown efficacy in yet another indication, achieving a 24% reduction in kidney disease-related events in people with type 2 diabetes and chronic kidney disease (CKD) in the FLOW trial.
… A turbulent series of events surrounding the supply of Eli Lilly’s blockbuster weight loss treatment has raised concerns around how the U.S. Earlier this month, the FDA declared an end to the shortage of Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, after almost two years.
It has now been 100 years since the first patient with diabetes received an injection of insulin, when Leonard Thomas, a 14-year-old boy, was treated with the hormone. In recent years, there have been more developments in the area of diabetes management, with the emergence of metformin and more recently semaglutide and dulaglutide.
Vertex Pharmaceuticals has announced new data from its phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated islet cell therapy in patients with type 1 diabetes (T1D) with impaired hypoglycaemic awareness and severe hypoglycaemic events (SHEs).
The drug is a selective, nonsteroidal mineralocorticoid receptor antagonist found to also protect against COVID-19 and pneumonia-related adverse events in patients with diabetes.
The new nano carrier could help people with diabetes avoid side-effects linked to insulin injections such as hypoglycemia, inform the researchers Research led by the University of Sydney and Sydney Local Health District has developed a system using nanotechnology that could allow people with diabetes to take oral insulin in the future.
At the recent Publicis Health Media HealthFront event, Preeti hosted a dialogue on the main stage with Dr. Minisha Sood. They discussed new GoodRx research and had a candid discussion about their daily challenges in caring for patients—especially those living with diabetes and obesity.
Food and Drug Administration recently warned patients and doctors about dosing errors associated with compounded versions of Novo Nordisk’s weight-loss and diabetes drugs. Overdoses with these drugs could cause adverse effects including severe nausea, vomiting and low blood sugar levels,” it added.
Jennifer Goldman discusses the importance of collaborative care between providers like endocrinologists, cardiologists, primary care physicians, and pharmacists to manage diabetes and prevent cardiovascular events.
The data was highlighted in poster presentations at the American Diabetes Association’s (ADA) 83rd Scientific Sessions held from June 23-26, 2023, in San Diego, CA. The data was highlighted in poster presentations at the American Diabetes Association’s (ADA) 83rd Scientific Sessions held from June 23-26, 2023, in San Diego, CA.
This innovation is designed to treat Community-Acquired Bacterial Pneumonia (CABP), a severe illness caused by drug-resistant bacteria, which disproportionately affects vulnerable populations, including children and the elderly as well as immune-compromised hosts like patients with diabetes, cancers etc.
The Medicines and Healthcare products Regulatory Agency (MHRA) granted a marketing authorisation for Vazkepa (icosapent ethyl) as a treatment to reduce risk of cardiovascular events in high-risk patients. absolute risk reduction in the first occurrence of major adverse cardiovascular events in comparison to placebo.
The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels.
Bayer’s blockbuster ambitions for diabetic kidney disease (DKD) drug candidate finerenone look a lot firmer with the publication of data from the phase 3 FIDELIO-DKD trial. Diabetes is the leading cause of kidney failure, and there are estimated to be almost 850 million people worldwide with chronic kidney disease (CKD).
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