According to the Heart Failure Society of America, nearly 6.5 million Americans over the age of 20 suffer from heart failure, which accounts for about 8.5% of all heart disease deaths in the United States. A new assay now aids in diagnosing individuals who are suspected of having acute heart failure in emergency departments, as well as in evaluating the severity and risk stratification of patients with heart failure and acute coronary syndrome. The Access NT-proBNP (N-terminal Pro B-type Natriuretic Peptide) assay from Beckman Coulter (Brea, CA, USA) measures the levels of N-terminal pro B-type natriuretic peptide in serum or plasma that is released in the heart. Elevated levels of these peptides may indicate heart failure. As per the latest heart failure guidelines issued by the American College of Cardiology and the American Heart Association, the Access NT-proBNP assay includes age-based cutoffs to aid in the accurate diagnosis of heart ...
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 ...
Novo Holdings’ $16.5 billion planned acquisition of Catalent is facing another delay. Just weeks after Novo decided to resubmit its application to the FTC, the agency is seeking more information about the deal. This move has triggered a second 30-day delay in the antitrust review process.Novo Holdings’ planned acquisition of Catalent is facing another delay. Just weeks after Novo Holdings decided to resubmit its application to the Federal Trade Commission, the agency is seeking more information about the deal. The transaction was originally expected to close by the end of this year, but this timeline may not be as solid given the repeated delays in the FTC’s review process. The acquisition was announced in early February when Novo Holdings — the investment arm of the foundation that owns a controlling stake in Danish pharma giant Novo Nordisk — disclosed its plans to acquire New Jersey-based contract development manufacturing organization Catalent ...
Amgen’s total revenues grew in Q1 2024 to $7.4bn, displaying a 22% increase from earnings reported in the first quarter of last year. The company reported an operating income of $3.1bn, on a non-GAAP [generally accepted accounting principles] basis. The non-GAAP earnings per share (EPS) dipped 1% to $3.96, with the decrease attributed to higher operating and interest expenses that resulted from the acquisition of Horizon Therapeutics. Amgen acquired Horizon for $27.8bn (£22.76bn) following approval from the US Federal Trade Commission (FTC) in October 2023. The revenue growth was driven by a 22% increase in product sales and a 25% volume growth, with ten products achieving double-digit volume growth. Key performers included hyperlipidemia immunotherapy Repatha (evolocumab) and osteoporosis treatment in postmenopausal women Evenity (romosozumab-aqqg), which grew 33% year-over-year (YoY) and 35% YoY respectively in Q1. Amgen also reported an 80% YoY growth for the severe asthma medication Tezspire (tezepelumab-ekko), and ...
It’s time we move beyond BMI and adopt a holistic approach to truly gauge health. By Gretchen Zimmermann Body Mass Index (BMI) has long been regarded as a standard measure for assessing weight-related health risks and, more recently, determining eligibility for anti-obesity medications like GLP-1 receptor agonists semaglutide (Wegovy) and tirzepatide (Zepbound), according to the FDA. BMI, calculated from weight and height, offers a simplistic yet flawed assessment of health. It was initially designed for non-Hispanic white populations and overlooks nuances like muscle mass, fat distribution, and ethnic background, which can influence certain risk factors. It’s an antiquated measure that perpetuates inequities in healthcare and misses the mark for calculating cardiometabolic conditions. The perception that a “normal” BMI is ideal and an “overweight to obese” BMI is not ideal only exacerbates bias within the medical community and complicates our efforts to solve the obesity crisis. Individuals with an overweight to ...
Senator Bernie Sanders has targeted the high drug prices of Novo Nordisk’s Ozempic and Wegovy, revealing that the Senate Committee on Health, Education, Labor, and Pensions (HELP) is investigating the “outrageously high” US prices of the blockbuster diabetes and obesity drugs. In a 24 April letter addressed to Novo Nordisk CEO Lars Fruergaard Jørgensen, Sanders, who serves as the HELP Committee chair, has requested answers from the multinational pharma by 8 May. The letter said the committee is investigating future reductions of the list and net prices of both Ozempic and Wegovy, R&D spending, cost and volume of goods sold, and prices paid by government payers. Additionally, Sanders requested that Novo Nordisk explain the price discrepancy between Wegovy and Ozempic given that they are different versions of the same drug, semaglutide, sold under two brand names. Sanders had previously put forth a proposal to cap prices on federally-funded drugs in ...
Tonghua Dongbao Pharmaceutical Co. (hereinafter referred to as the “Company”, “Tonghua Dongbao”), a wholly-owned subsidiary of Tonghua Dongbao Zixing (Hangzhou) Biomedicine Co., Ltd. has recently obtained the clinical trial approval for THDBH120 for weight loss indication from the Center for Drug Evaluation (CDE) of the State Drug Administration. THDBH120 for injection for the indication of weight loss drug clinical trial approval notice. The approval of the clinical application for THDBH120 for weight loss indication for injection signifies that the company’s GLP-1 pipeline in the field of overweight and obesity treatment has also stepped into the phase of clinical trials, which is of milestone significance. In the future, the Company will accelerate the research and development progress of THDBH120 for injection in diabetes indication and weight loss indication, and further explore and tap the potential of other indications to maximize the value of the product. THDBH120 for injection has a huge ...
Biopharmaceutical companies are regaining interest in metabolic dysfunction-associated steatohepatitis (MASH) innovator drug development. MASH innovator drugs witnessed over $2.5 billion increase in the total value of partnership deals from 2020 to 2024 year-to-date (YTD), with more than $2 billion forged in Q1 2024 alone, reveals GlobalData. MASH, previously known as nonalcoholic steatohepatitis (NASH), is a disease characteriSed by liver inflammation and damage caused by the accumulation of fat. Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), a small molecule THRB agonist, was the first drug approved by the FDA for MASH in March 2024. Alison Labya, Business Fundamentals Analyst at GlobalData, comments, “Interest in MASH has returned in light of the FDA approval of Madrigal’s Rezdiffra, as well as the success of GLP-1 obesity drugs and their potential efficacy in MASH, as demonstrated by Eli Lilly’s Zepbound (tirzepatide; also known as Mounjaro for type 2 diabetes) in its Phase II SYNERGY-NASH trial readout.” However, ...
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