Search Results for “ diabetes” – Page 16 – media

German CDMO outlays $980m on GLP-1 manufacturing expansion

German contract development and manufacturing organisation (CDMO) Corden Pharma announced a €900m ($980m) investment to expand its diabetes drug manufacturing capabilities, as shortages persist around the world. The company declared that the investment would be used over the next three years to expand its peptide manufacturing capabilities at sites in Colorado, US, and Europe. The facilities will have a particular focus on GLP-1 peptide manufacturing, as the demand increases. In a 16 July press release, the company spoke of multiple long-term contracts worth more than €3bn with potential benefits. Last year, the company signed a major deal with Eli Lilly to manufacture the active pharmaceutical ingredient for its leading obesity drug Mounjaro (tirzepatide), as per a Reuters report. In January 2023, the company also shared the signing of a $1bn multi-year agreement to manufacture a large volume peptide with an undisclosed company. The latest investment will be used to construct ...
- Source: drugdu
- 76
- July 19, 2024
Cohort Study Compares Weight Loss Effects of Tirzepatide vs. Semaglutide

By Don Tracy, Associate Editor JAMA study aims to discover how weight loss differs between patients receiving tirzepatide compared with semaglutide among a clinical population of overweight of obese adults. Tirzepatide and semaglutide are both GLP-1 agonists that have demonstrated the ability to offer significant weight reduction in patients with obesity, with or without type 2 diabetes (T2D). There are currently no real-world data comparing the effectiveness of the two in treating overweight or obese populations. In a cohort study recently published in JAMA Internal Medicine, researchers set out to provide a head-to-head comparison of these medications in a real-world clinical setting, focusing on weight loss outcomes and gastrointestinal adverse events (AEs). The study included 18,386 patients who were new users of tirzepatide or semaglutide with overweight or obesity, regardless of T2D status. Additionally, patients were selected based on their electronic health records data and propensity-score matched to ensure comparability. ...
- Source: drugdu
- 110
- July 16, 2024
FDA Says ‘No’ to Novo Nordisk’s Once-Weekly Insulin

The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news. By Frank VinluanNovo Nordisk’s bid to bring diabetes patients a less burdensome dosing regimen has encountered a setback. The FDA turned down the company’s application for icodec, a slow-acting insulin the company designed for once-weekly dosing as an alternative to daily insulin injections. According to Novo Nordisk, the FDA’s complete response letter raised questions about icodec’s manufacturing process as well as the use of the product in patients with type 1 diabetes. In May, an FDA advisory committee concluded that the available data were not sufficient to show that icodec’s benefits outweigh its risks in type 1 diabetes. Some committee members expressed concerns about icodec’s ...
- Source: drugdu
- 99
- July 16, 2024
Aspect wins $72.75m from Canadian government for bioprinted pipeline

Canadian biotech Aspect Biosystems has received a $72.75m government investment to advance its proprietary bioprinting technology. The funding, from the governments of Canada and British Columbia (BC), is set to support a $200m multi-year project to advance Aspect’s clinical biomanufacturing capabilities, full-stack tissue therapeutic platform, and bio-printed tissue therapeutic portfolio. Aspect develops bioprinted tissue therapeutics designed to replace or support specific biological functions. According to the company, these implantable, allogeneic cell-based therapies offer solutions such as retrievable implants, and integrated tissues. Aspect’s tissue therapeutic platform is said to combine the company’s bioprinting technology, therapeutic cells, biomaterials, and computational design. In April 2023, Aspect announced a partnership with Novo Nordisk to produce tissue therapeutics for diabetes. Aspect received $75m from Novo in initial payments, with Novo potentially giving Aspect up to $650m in future payments for each of the four potential products arising from the partnership. The collaboration has so far ...
- Source: drugdu
- 95
- July 13, 2024
After AdCom rejection, FDA rebuffs Novo Nordisk’s once-weekly insulin

The US Food and Drug Administration (FDA) has rejected the biologics licence application (BLA) for Novo Nordisk’s once-weekly insulin icodec for the treatment of diabetes mellitus. The company did not disclose the details of the complete response letter (CRL) issued by the FDA. But did share that the CRL outlined concerns related to the “manufacturing process and the type 1 diabetes (T1D) indication”. Novo Nordisk also added that the company did not expect to fulfil the requests detailed in the CRL by the end of this year, and consequently will not be refiling the BLA for insulin icodec until next year, at the earliest. The BLA rejection news comes two months after the FDA Endocrinologic and Metabolic Drugs Advisory Committee (AdCom) voted against the approval of insulin icodec for T1D. In a 7-4 vote, the panel found that insulin icodec’s benefits do not outweigh its risks, especially the elevated risk ...
- Source: drugdu
- 95
- July 13, 2024
Amylyx Aims to Help Patients With a Novel GLP-1 Drug, But Not the Way You Think

Unlike GLP-1 agonist drugs marketed for weight loss, new Amylyx Pharmaceuticals drug avexitide blocks its target receptor. Amylyx plans to advance this GLP-1 antagonist into Phase 3 testing for post-bariatric hypoglycemia, a rare condition in which blood sugar levels drop precipitously. By Frank VinluanBefore GLP-1 drugs became a wildly popular pharmacologic way to treat obesity, bariatric surgery was a top option for those seeking a medical intervention for losing weight. While this procedure is effective for weight loss, it turns out that changing the structure of the gut can lead to a debilitating disorder in some patients. Amylyx Pharmaceuticals, months removed from a clinical trial failure that shattered its prospects in neurodegeneration, is now planting a flag in metabolic disease with the acquisition of a Phase 3-ready drug for this rare disorder with no FDA-approved therapies. The drug comes from Eiger BioPharmaceuticals, which last month sold off its assets in ...
- Source: drugdu
- 74
- July 12, 2024
SMC accepts Boehringer/Lilly’s Jardiance for CKD within NHS Scotland

The Scottish Medicines Consortium (SMC) has accepted Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) for use within NHS Scotland to treat adult patients living with chronic kidney disease (CKD). The regulator has indicated the therapy for adult CKD patients who are receiving optimised standard care, including angiotensin converting enzyme inhibitors or angiotensin 2 receptor blockers, with either an estimated glomerular filtration rate (eGFR) of 20ml/min/1.73m2 up to 45ml/min/1.73m2 or an eGFR of 45ml/min/1.73m2 up to 90ml/min/1.73m2. Additionally , patients in Scotland in the 45ml to 80ml group will now be eligible to receive Jardiance if they have a urine albumin-to-creatine ratio of 22.6mg/mmol or more or type 2 diabetes (T2D) mellitus. Affecting nearly 850 million people worldwide, CKD is a serious, progressive condition that is caused by decreased kidney function and is often triggered by diabetes, hypertension and glomerulonephritis. Already approved in the EU and US, Jardiance is an oral, ...
- Source: drugdu
- 79
- July 11, 2024
Hengrui Pharmaceuticals’ Innovative Drug HRS-7249 Injection for the Treatment of Hyperlipidemia Approved for Clinical Trials

Recently, Hengrui Pharmaceuticals’ subsidiary Fujian Shengdi Pharmaceutical Co., Ltd. received a Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, which approved HRS-7249 Injection, a Class 1 new drug, to carry out clinical trials for the treatment of hyperlipidemia. Upon inquiry, no similar products have been approved for marketing at home and abroad for the time being. Hypertriglyceridemia (HTG) is a common type of dyslipidemia. Epidemiologic studies have shown that HTG is one of the risk factors for atherosclerotic cardiovascular disease (ASCVD) and acute pancreatitis, and is clearly associated with overweight/obesity, insulin resistance/type 2 diabetes mellitus, non-alcoholic fatty liver disease, and chronic kidney disease. Currently, triglyceride-lowering drugs often used in clinical practice have limited reduction of triglycerides and have adverse effects such as hepatic and renal impairment, increased risk of atrial fibrillation, and decreased insulin sensitivity, and safer and more effective drugs are needed for ...
- Source: drugdu
- 99
- July 8, 2024
Study reveals cardiovascular health could be biggest risk factor for dementia

Dementias, including Alzheimer’s disease, are estimated to affect 944,000 people in the UK Researchers from University College London (UCL) have revealed that cardiovascular health could be the biggest risk factor associated with future dementia. Published in the Lancet Public Health, the study was funded by the National Institute for Health and Care Research’s Three Schools’ Dementia Research Programme. Estimated to affect 944,000 people in the UK, dementia is a general term for the impaired ability to remember, think, or make decisions that affects everyday life. The most prevalent dementias include Alzheimer’s disease, vascular dementia, Lewy body dementia and frontotemporal dementia. Researchers analysed and extracted data from 27 papers involving people with dementia worldwide, with data collected between 1947 and 2015 and the latest paper published in 2020. The extracted information from each paper about dementia risk factors was then used to calculate what proportion of dementia cases were attributable to ...
- Source: drugdu
- 104
- July 5, 2024
Dexcom to lay off 535 employees in California

Dive Brief Dexcom will lay off 535 employees in California, adding to the medical device industry’s long list of job cuts this year. The expected first date of separation is July 26, and the layoffs are connected to one site in San Diego, according to a Worker Adjustment and Retraining Notification filing with California. “Dexcom has decided to centralize its [U.S.] manufacturing operations in Mesa, Arizona, and refocus our San Diego operations as a Global Center of Excellence for Product Innovation,” company spokesperson James McIntosh wrote in an emailed statement. He added that Dexcom is offering support for employees, such as allowing them to apply for similar roles at another U.S. site with relocation assistance. Dive Insight The layoffs continue the consistent stream of job cuts in the medtech industry over the past 18 months. This year alone has seen numerous layoffs from top medical technology companies, including Medtronic, Zimmer ...
- Source: drugdu
- 63
- July 2, 2024

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