The Phase 3 results for ocedurenone come less than nine months after Novo Nordisk acquired the drug from KBP Biosciences. Novo Nordisk has stopped the clinical trial in uncontrolled hypertension and chronic kidney disease, but is evaluating potential applications of the small molecule in other indications. By Frank VinluanA Novo Nordisk drug for hypertension and chronic kidney disease has failed a pivotal study, a setback to the Danish pharmaceutical giant’s effort to bring patients a new therapy with potential safety and efficacy advantages over currently approved medications in the drug class, including a product marketed by Bayer. Novo Nordisk did not release specific details about the Phase 3 results for the drug, ocedurenone. The company said Wednesday that an independent data monitoring committee recommended stopping the trial after a prespecified interim analysis. Ocedurenone is a small molecule designed to block the mineralocorticoid receptor. When overactivated, this receptor can contribute to ...
The Phase 3 results for ocedurenone come less than nine months after Novo Nordisk acquired the drug from KBP Biosciences. Novo Nordisk has stopped the clinical trial in uncontrolled hypertension and chronic kidney disease, but is evaluating potential applications of the small molecule in other indications. By Frank Vinluan A Novo Nordisk drug for hypertension and chronic kidney disease has failed a pivotal study, a setback to the Danish pharmaceutical giant’s effort to bring patients a new therapy with potential safety and efficacy advantages over currently approved medications in the drug class, including a product marketed by Bayer. Novo Nordisk did not release specific details about the Phase 3 results for the drug, ocedurenone. The company said Wednesday that an independent data monitoring committee recommended stopping the trial after a prespecified interim analysis. Ocedurenone is a small molecule designed to block the mineralocorticoid receptor. When overactivated, this receptor can contribute to ...
On June 25, Chiatai Tianqing received the Certificate of Drug Registration approved by the State Drug Administration, and the company’s liraglutide injection was approved to be listed in the market, which is used for controlling blood glucose in adult patients with type 2 diabetes mellitus. This is the ninth new product (including new indications) approved by Chiatai Tianqing since this year. The approval of this product also marks Chiatai Tianqing’s formal entry into the field of biopharmaceutical glycemic control. Liraglutide is a long-acting analog of glucagon-like peptide-1 (GLP-1) with 97% homology to natural GLP-1, an endogenous enteric insulinotropic hormone that enhances glucose-dependent insulin secretion from pancreatic β-cells. In addition to pancreatic islet cells, GLP-1 receptors are widely present in gastrointestinal, lung, brain, kidney, cardiovascular system and other organs and tissues. Liraglutide prolongs the half-life of GLP-1 on the basis of retaining the physiological action characteristics of GLP-1, and needs to ...
Dive Brief Abbott said Monday it will launch two over-the-counter continuous glucose monitors after receiving clearance from the Food and Drug Administration. One product is the company’s Lingo device, sold as a wellness product for people who do not have diabetes. The other is Abbott’s new Libre Rio device, which is intended for adults with Type 2 diabetes who do not use insulin, posing a direct challenge to Dexcom’s Stelo device. After Lingo was cleared last week, RBC Capital Markets analyst Shagun Singh wrote the over-the-counter nod could offer a more than $1 billion sales opportunity for Abbott. Dive Insight Abbott had discussed plans to bring Lingo to the U.S. after releasing it in the U.K. last year. The device, which can be worn on the upper arm for 14 days, tracks glucose to help people understand how their bodies react to different foods, exercise and stressors. Abbott received FDA ...
Affecting more than 7 million people in the UK, cardiovascular diseases are conditions that affect the heart or circulation The British Heart Foundation (BHF) has awarded a total of £35m in funding to nine universities across the UK to help strengthen world-leading cardiovascular disease research. Provided through BHF’s Research Excellence Awards scheme, the funding will support research environments that encourage collaboration, inclusion and innovation to accelerate lifesaving breakthroughs. Affecting around 7.6 million people in the UK, cardiovascular disease is a term for conditions that affect the heart or circulation, including high blood pressure, stroke, heart disease and vascular dementia. The nine universities to receive part of the funding include Imperial College London (ICL), King’s College London (KCL), the University of Cambridge, Edinburgh, Leeds, Leicester, Manchester, Oxford and University College London. For the next five years, the funding will enable cutting-edge research to address some of the biggest cardiovascular disease challenges, ...
Click Therapeutics is acquiring the assets of Better Therapeutics two months after that digital therapeutics developer announced it would lay off all employees and shut down. Better’s main asset is AspyreRx, an FDA-authorized mobile app for type 2 diabetes. By Frank VinluanDigital therapeutics developer Click Therapeutics is building up its prospects in cardiometabolic disorders by acquiring the assets of Better Therapeutics, a company whose technology platform yielded one FDA-authorized product and could serve as a springboard for a range of drug and digital treatment pairings. Better’s FDA-authorized prescription digital therapeutic, named AspyreRx, is a type 2 diabetes mobile app that helps patients modify behaviors in order to change the course of their disease. Artificial intelligence enables the software to personalize treatment plans to each patient. AspyreRx secured FDA authorization last summer, but Better struggled to commercialize the product on its own. Payer coverage decisions on the app were pending as ...
Biocon announced the signing of an exclusive licensing and supply agreement with Handok, a pharma company in South Korea, for the commercialisation of its vertically integrated, complex drug product, Synthetic Liraglutide. Liraglutide is an injection in a pre-filled pen, used in the treatment of chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity. Under the terms of this agreement Biocon will undertake the development, manufacturing and supply of the drug product, and Handok will be responsible for obtaining regulatory approval and commercialisation in the South Korean market. Siddharth Mittal, Chief Executive Officer and Managing Director, Biocon, said “We are pleased to enter into this strategic partnership with Handok, which will enable patients in South Korea dealing with weight management to gain access to our GLP-1 peptide drug product, Synthetic Liraglutide.” YoungJin Kim, Chairman of Handok, commented, “Liraglutide is an important drug product for treating diabetes ...
Innovent Biologics has unveiled Phase III (DREAMS-2) results for mazdutide, indicating superiority over dulaglutide in glycaemic control for type 2 diabetes (T2D) patients in China. “With its potential to revolutionise T2D treatment, mazdutide’s success could not only reshape the landscape of diabetes therapeutics in China but also underscores the growing demand for innovative solutions amidst the escalating prevalence of T2D in the region,” says GlobalData. Mazdutide is reportedly the only glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist to reach Phase III stage of development (China) for type 2 diabetes (T2D) globally. DREAMS-2 (NCT05606913) Phase III study compared the efficacy and safety of mazdutide and dulaglutide in Chinese subjects with T2D, who have inadequate glycemic control with metformin monotherapy or combination therapy of metformin with other oral drugs. The primary endpoint was successfully met, showing the robust glucose-lowering efficacy of mazdutide. The key secondary endpoints showed mazdutide’s superior ...
With an aim to enhance its global presence and deliver high-quality medicines to a broader market, the Ahmedabad based, HOF Pharmaceuticals has shared its plans for growth. In two years, HOF Pharma has established itself as a manufacturer and exporter of tablets, capsules, and oral liquids. Reportedly, the company’s plant at Sanand, Ahmedabad meets stringent international standards. “Currently we are exporting to 12 countries across Latin America, Africa, and Southeast Asia. With twenty more specialty products in the pipeline, which will augment HOF’s export performance, we are now aiming to double our reach to 25 countries within the next year” commented Pravin Patel, Chairman, HOF Pharma. “Towards this year end, we are gearing up our Quality Management Systems (QMS) and formulation development initiatives towards regulated markets,” added Patel. HOF Pharma comprises over 150 products across various therapeutic categories. These include treatments for diabetes, cardiovascular, central nervous system disorders, immunosuppressant, anticoagulants, ...
Eli Lilly says its capital commitment to its new Indiana site is the largest manufacturing investment in the company’s history. The site will make tirzepatide, the active pharmaceutical ingredient in both Zepbound and Mounjaro. By Frank VinluaEli Lilly is boosting its ability to meet growing demand for the metabolic disorder drugs Zepbound and Mounjaro, committing $5.3 billion toward the expansion of a site that will produce the main pharmaceutical ingredient in both medications. Lilly broke ground on the Lebanon, Indiana, site in 2023. The expansion announced Friday brings Lilly’s total investment in the site to $9 billion. The company expects this facility will begin making medicines in late 2026. Mounjaro, approved in 2022 for treating type 2 diabetes, has become a blockbuster seller with 2023 revenue totaling $5.1 billion. Zepbound was approved late last year for chronic weight management. Both medications are incretins, drugs that mimic a gut hormone to ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.