Search Results for “cardiovascular” – Page 14 – media

Avzivi® (BAT1706) receives marketing approval from European Commission

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company is dedicated to the development of a new generation of innovative drugs and biosimilars for the treatment of oncology, autoimmune diseases, cardiovascular diseases, ophthalmology, and other major diseases that threaten human life or health. The Company recently received notification from the European Commission that Avzivi (BAT1706), a biosimilar developed by BIO-THERA with reference to Avastin® (bevacizumab), Intravenous Solution, has been granted marketing authorization by the European Commission for the treatment of metastatic colorectal, metastatic breast, non-small-cell lung, renal-cell, epithelial ovarian, fallopian tube or primary peritoneal, and cervical cancer. The decision was based on a positive review opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). In September 2021, BIO-THERA signed a commercialization and license ...
- Source: drugdu
- 81
- August 1, 2024
FDA Approves Alpha Cognition’s Zunveyl as Oral Therapy for Mild-to-Moderate Alzheimer Disease

July 29, 2024 By Don Tracy, Associate Editor Approval of Zunveyl offers a novel approach with a dual mechanism of action designed to improve tolerability and efficacy in treating Alzheimer disease, company says.The FDA has approved Alpha Cognition’s Zunveyl (benzgalantamine), an oral therapy for treating mild-to-moderate Alzheimer disease (AD). According to the company, the approval marks a significant advancement in the treatment of AD by offering a novel approach with a dual mechanism of action designed to improve tolerability and efficacy. Zunveyl is a prodrug of galantamine, an acetylcholinesterase inhibitor (AChEI), that works by preventing the breakdown of acetylcholine, a crucial neurotransmitter involved in memory and attention. Alpha Cognition stated that Zunveyl functions as an allosteric potentiator, enhancing the release of acetylcholine from presynaptic neurons.1 “I am very excited about the approval of Zunveyl, which we believe offers better tolerability for patients with Alzheimer’s disease. We have always believed in ...
- Source: drugdu
- 92
- July 31, 2024
FDA Approval of Alopecia Drug Positions Sun Pharma to Compete With Eli Lilly, Pfizer

Leqselvi is now FDA approved for treating severe alopecia areata. Sun Pharma added the oral drug to its pipeline via the $576 million acquisition of Concert Pharmaceuticals last year. By Frank Vinluan Hair loss caused by alopecia areata now has a new FDA-approved treatment, a third-in-class drug from Sun Pharmaceutical Industries that will compete against commercialized medicines from Eli Lilly and Pfizer. The regulatory decision announced Friday for the drug, deuruxolitinib, covers the treatment of adults with severe alopecia areata. Mumbai, India-based Sun Pharma, which has U.S. operations in Princeton, New Jersey, will market the twice-daily pill under the brand name Leqselvi. Alopecia areata is a condition in which the immune system attacks hair follicles, causing sudden hair loss. The disorder affects both males and females. While the hair loss mainly happens on the scalp, the condition can affect other parts of the body. Sun Pharma cites studies estimating that 700,000 ...
- Source: drugdu
- 126
- July 30, 2024
FDA approves Sun Pharma’s JAK inhibitor for alopecia

Sun Pharmaceutical Industries has secured the US Food and Drug Administration (FDA) approval for its oral Janus kinase (JAK) Inhibitor Leqselvi (deuruxolitinib) to treat severe alopecia areata. Originally developed by Concert Pharmaceuticals, Sun Pharma inherited the asset when it purchased Concert Pharmaceuticals in January 2023 for $576m. Alopecia areata is an autoimmune condition where the immune system attacks hair follicles, leading to sudden, patchy hair loss. JAK inhibitors such as Leqselvi block the activity of Janus kinase enzymes, which are involved in the signalling pathways that drive inflammation and immune responses. The FDA approval is based on data gathered from two Phase III studies—THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650)—where Leqselvi restored scalp hair coverage by at least 80% in more than 30% of patients after 24 weeks. The 1,220 patients enrolled across the two studies had alopecia areata with at least 50% scalp hair loss as measured by Severity of ...
- Source: drugdu
- 120
- July 29, 2024
Protein Signatures in Blood Can Predict Risk of Developing More Than 60 Diseases

Measuring specific proteins to diagnose conditions like heart attacks, where troponin is tested, is a well-established clinical practice. Now, new research highlights the broader potential of protein measurements from a small blood sample to predict a variety of diseases. In the research, published in Nature Medicine, which was carried out as part of an international partnership involving Queen Mary University of London (London, UK), the investigators used data from the UK Biobank Pharma Proteomics Project (UKB-PPP). This project represents the largest proteomic study to date, analyzing around 3,000 plasma proteins from over 40,000 randomly selected UK Biobank participants. These protein measurements are linked to detailed electronic health records. The researchers applied sophisticated analytical techniques to identify a specific ‘signature’ of 5 to 20 key proteins for predicting each disease. They discovered that these protein ‘signatures’ can predict the onset of 67 different diseases, including multiple myeloma, non-Hodgkin lymphoma, motor neuron ...
- Source: drugdu
- 81
- July 25, 2024
Exploring the expanding horizons of GLP-1 therapies beyond diabetes and obesity

In a Perspective, Daniel Drucker highlights the growing body of evidence that hints at the potential of glucagon-like peptide-1 (GLP-1)-based medications in treating conditions other than diabetes and obesity, including cardiovascular disease and neurodegenerative disorders. GLP-1 is a hormone released from the gut after eating that enhances glucose-dependent insulin secretion. Pharmacological GLP-1 receptor (GLP-1R) activation reduces glucagon secretion and slows gastric emptying, making it an effective treatment for type 2 diabetes. Later studies found that GLP-1 administration also inhibited food intake through GLP-1R activation in the brain, leading to their use in treating obesity. Recently, research has demonstrated that GLP-1 drugs produce additional health benefits beyond glucose and weight control, including reduced heart and kidney diseases. Here, Drucker discusses the potential mechanisms underlying these benefits, such as reducing systemic inflammation, and their implications for future clinical applications and drug development. According to Drucker et al., GLP-1 drugs have shown promise ...
- Source: drugdu
- 92
- July 22, 2024
Rona Therapeutics gains Series A+ funds for siRNA pipeline expansion

Rona Therapeutics has secured $35m in its Series A+ financing round to advance its metabolic small interfering RNA (siRNA) pipeline in clinical settings. The company will also use the investment proceeds to develop next-generation RNA platforms. LongRiver Investments spearheaded the financing round, which saw contributions from Zhaode Investment, Zhongqi Capital, BioTrack Capital and Lilly Asia Ventures. LongRiver Investments will become part of Rona’s board. The company focuses on developing siRNA programmes, with its first product, RN0191, having completed Phase I clinical studies in Australia and China. In December 2023, Rona received clinical trial application clearance from the National Medical Products Administration in China to assess RN0191 injection to treat hypercholesterolemia, mixed hyperlipidemia and atherosclerotic cardiovascular disease, to reduce the risk of cardiovascular events. The asset is set to enter Phase II clinical development for hypercholesterolemia. Rona’s second programme, RN0361, is scheduled to enter clinical trials in the second quarter of ...
- Source: drugdu
- 76
- July 22, 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
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
- 77
- July 11, 2024
FDA Grants Fast Track Designation to Inozyme Pharma’s INZ-701, a Treatment for Patients with ABCC6 Deficiency

By Don Tracy, Associate Editor The Fast Track designation for INZ-701 was based nonclinical pharmacology data and preliminary safety and efficacy data from the ongoing Phase I/II trial of INZ-701 in adults with ABCC6 Deficiency. The FDA has granted Fast Track Designation for Inozyme Pharma’s INZ-701, aimed to treat patients with ABCC6 Deficiency. According to the company, the Fast Track designation was based on preliminary safety and efficacy data from its ongoing Phase I/II trial of INZ-701 in adults with ABCC6 Deficiency, as well as nonclinical pharmacology data. Inozyme believes that INZ-701’s development process will benefit from more frequent engagement with the FDA and expedited regulatory review.1 “Through Fast Track designation, the FDA recognizes the potential of INZ-701 in ABCC6 Deficiency. We plan to work closely with the agency to establish an efficient path to approval. Receipt of Fast Track designation underscores our belief that INZ-701 could serve as an ...
- Source: drugdu
- 115
- July 8, 2024

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