Novo Nordisk has announced that the European Medicine Agency’s advisory committee has recommended Awiqli (once-weekly basal insulin icodec) to treat diabetes in adults. The recommendation from the Committee for Medicinal Products for Human Use (CHMP) was based on positive results from the phase 3a ONWARDS clinical trial programme. Estimated to affect 415 million people worldwide, diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin, a hormone that regulates glucose, or when the body cannot effectively use the insulin it produces. Awiqli works to cover the basal insulin requirements for a week with a single subcutaneous injection. Comprising six phase 3a global clinical trials involving more than 4,000 adults with type 1 or type 2 diabetes, the ONWARDS clinical development programme investigated the efficacy and safety of Awiqli. Results from the programme showed that Awiqli achieved a superior blood sugar reduction and superior time in ...
Type 2 diabetes is estimated to affect 462 million people worldwide An international academic consortium led by Johns Hopkins University, US, the Chinese University of Hong Kong and Lund University, Sweden, has identified 13 biomarkers that improve the ability to accurately predict the risk of cardiovascular disease in people with type 2 diabetes. The study was conducted by 23 experts across 11 countries as part of an international partnership between the American Diabetes Association and the European Association for the Study of Diabetes, the Precision Medicine in Diabetes Initiative. Estimated to affect around 462 million people globally, type 2 diabetes is a condition that causes too much sugar in the blood. Patients living with the condition are two times more likely to go on to develop cardiovascular disease compared to those without diabetes. Researchers reviewed and analysed the medical studies published from 1990 onward that investigated the differences between people ...
Drug shortages are continuing to persist in the UK affecting patients with different conditions, including those with type-2 diabetes who are on GLP-1 receptor agonists (GLP-1 RAs). Earlier this month, NHS England issued a National Patient Safety Alert regarding the shortage of GLP-1Ras. This was following a similar one issued in July 2023, which stated and that supplies were unlikely to stabilise sufficiently to meet market demand until at least mid-2024. In response to the January alert, the Diabetes UK issued a statement saying such shortages were being seen globally due to an increase in off-label use of semaglutide for weight loss. The alert issued actions to be taken by healthcare workers, such as only prescribing GLP-1 RAs for their licensed indications, and prescribing Rybelsus, another form of the GLP1RA semaglutide, for new treatment initiations and for those patients who can be switched from AstraZeneca’s Byetta (exenatide) and Novo Nordisk’s ...
Pharma giant AstraZeneca will spend $26.5 million to build a new production line for its diabetes treatments dapagliflozin and metformin hydrochloride at the Taizhou National Medical High-tech Development Zone in Jiangsu, China Daily reports. The facility is forecast to have an annual output value of $1.4 billion and is expected to become a global manufacturing outpost for the company’s diabetes therapies, according to the publication. Marketed in the U.S. as Farxiga, dapagliflozin helps prevent absorption of glucose in the kidneys to help lower blood sugar. Metformin, meanwhile, reduces the absorption of sugar from the stomach. As a combination therapy, the medicines are marketed as Xigduo. Fierce Pharma Manufacturing has reached out to AstraZeneca for additional details on the project. AstraZeneca’s operations in China were the focus of market speculation last summer when the Financial Times reported that the company had explored separating its business in the country amid increasing geopolitical ...
Eli Lilly has created a website to make it easier for patients to access medicines including its hot obesity drug Zepbound. The website, LillyDirect, combines telehealth and pharmacy services to provide access to Lilly’s portfolio of diabetes, migraine and obesity medicines. Companies including the weight loss program providers Noom and WeightWatchers have begun offering telehealth services to help people access Lilly’s Zepbound and Novo Nordisk’s Wegovy. Drugmakers have kept in their lane, though, developing and manufacturing medicines without getting into the business of connecting patients to physicians and delivering products to their homes. LillyDirect marks a shift in strategy, at least for Lilly. The website features sections to help people access healthcare, either remotely or in person, and details of how to send prescriptions to LillyDirect Pharmacy Solutions to get home deliveries of Lilly drugs. Lilly CEO David Ricks set out the thinking behind LillyDirect in a statement, framing the ...
NFL players aim to boost awareness of Type 1 diabetes under a new charitable campaign. The “My Cause My Cleats” campaign will see NFL players wear custom-painted cleats during some football games to raise awareness and funds for charitable causes. In 2024, Type 1 diabetes has become a core theme, with Mark Andrews of the Baltimore Ravens, Orlando Brown Jr. of the Cincinnati Bengals, Blake Ferguson of the Miami Dolphins, Collin Johnson of the Chicago Bears, Chad Muma of the Jacksonville Jaguars, Nate Peterman of the Chicago Bears, and Kevin Radar of the Tennessee Titans, all lacing up for the cause. More than 1.4 million Americans are affected by Type 1 diabetes, an autoimmune disease that causes the pancreas to produce little or no insulin. The disease typically hits at a young age, and is separate from Type 2 diabetes, which typically affects adults and can be related to obesity. ...
Dec 21 (Reuters) – The U.S. Food and Drug Administration on Thursday warned consumers not to use counterfeit versions of Novo Nordisk’s (NOVOb.CO) diabetes drug Ozempic that have been found in the country’s drug supply chain. The health regulator said it will continue to investigate counterfeit Ozempic 1 milligram injections and has seized thousands of units, but flagged that some may still be available for purchase. Danish drugmaker Novo Nordisk and the FDA are testing the seized products and do not yet have information about the drugs’ identity, quality or safety, the agency said. Novo said the seizures took place in warehouses outside the company’s authorized supply chain. The agency said the needles from the seized injections are counterfeit and their sterility cannot be confirmed, which presents an additional risk of infection for patients. Other confirmed counterfeit components from the seized products include the pen label and accompanying information about ...
AstraZeneca (AZ) has shared positive results from a late-stage trial evaluating its oral SGLT2 inhibitor Forxiga (dapagliflozin) in children and adolescents with type 2 diabetes (T2D). T2D is the most common type of diabetes, accounting for over 90% of cases worldwide, and its prevalence in children and adolescents is increasing globally. The disease is characterised by pathophysiologic defects leading to elevated glucose levels, which over time contribute to further disease progression. “Despite the growing global burden of T2D among children and adolescents, the treatment options available are currently limited,” said Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, AZ. “It is well documented that some patients find injectable therapies challenging, making the need for effective oral treatment alternatives paramount,” he added. AZ’s phase 3 T2NOW, which is one of the largest paediatric T2D studies performed to date, assessed the efficacy and safety of Forxiga as an add-on treatment in children ...
Novo Nordisk and the Broad Institute of MIT and Harvard have announced a new research alliance to address ‘critical unmet clinical needs’ in diabetes and cardiometabolic diseases. The collaboration aims to identify disease-modifying interventions to improve the standards of care for people living with type 2 diabetes and cardiac fibrosis. The Novo side of the collaboration is secured through the Novo Nordisk Bio Innovation Hub, a research and development unit designed for life sciences innovation and focused on cardiometabolic, rare blood and rare endocrine disorders. Utilising state-of-the-art genetics and genomics methods, the collaboration aims to interrogate subtypes of diabetes. Along with the Broad’s Center for the Development of Therapeutics, using large-scale cell screens, the research will focus on the relationships between genes and pathways that could be therapeutic targets. Type 2 diabetes affects more than 37 million people in the US. Scarring of the heart, or cardiac fibrosis, is common ...
Dive Brief A plaintiff has accused Medtronic of sharing user data for its InPen diabetes management system with companies including Google. The lawsuit alleges that Medtronic’s MiniMed business used digital platforms to acquire “a treasure trove of personal data” and shared the information with third parties to increase revenue and profits. According to the plaintiff in the proposed class action lawsuit, the disclosures to Google are “particularly problematic” because his use of Gmail meant his personal information was “automatically linked to his real identity.” Dive Insight The case centers on the app that accompanies Medtronic’s smart insulin pen. Medtronic created the app to help patients record their insulin doses, receive reminders and share data with their healthcare team. The use of the data is covered by Medtronic’s notice of privacy practices. According to the lawsuit, the company has used the data in ways that are beyond the terms covered in ...
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