On January 16, China Biopharmaceutical announced that the Group has initiated a Phase III clinical study of Semaglutide Injection in China for the indication of type 2 diabetes mellitus. Semaglutide is a long-acting glucagon-like peptide-1 (GLP-1) analog with 94% sequence homology to human GLP-1, a peptide secreted by small intestinal L-cells, which is known for its ability to increase insulin synthesis and secretion, inhibit appetite, and delay gastric emptying. Semaglutide reduces blood glucose by stimulating insulin secretion and decreasing glucagon secretion. Semaglutide is the first weekly GLP-1 formulation in China with both hypoglycemic and cardiovascular indications, and its effects in lowering blood glucose, reducing body weight, and cardiovascular protection in diabetes have been well proven. Compared with the previous generation of glucose-lowering drugs, Semaglutide’s outstanding advantage is its longer half-life, which allows it to be administered once a week, greatly improving patient compliance. Currently, Semaglutide has become one of the ...
Despite persistent supply hitches since Wegovy’s launch in 2021, Novo Nordisk has quickly garnered blockbuster sales in the newly untapped obesity market. And to hear Novo’s CEO Lars Fruergaard Jørgensen tell it, the company is “just getting going” in the field. In 2024, Novo Nordisk plans to entrench itself even deeper into the burgeoning obesity market, Jørgensen said Tuesday at the 42nd annual J.P. Morgan Healthcare Conference. To get there, Novo will rely on expanded manufacturing capacity, new cardiovascular outcomes data and a surprise boost from Eli Lilly’s rival weight-loss drug Zepbound, which snagged its own obesity nod in November. Novo’s Wegovy proved immensely popular out the gate. Initially, the company struggled to contend with the unprecedented spike in demand for its new semaglutide-based medicine. But after a sustained manufacturing expansion campaign over the past two years, Jørgensen figures Novo is in a comfortable position moving into 2024. In 2023, ...
Dive Brief Livanova is closing its circulatory support unit to focus on larger, faster-growing cardiopulmonary and neuromodulation opportunities. The advanced circulatory support (ACS) business sells the Lifesparc device, which pumps blood during cardiovascular surgeries, but sales have fallen and then flatlined since peaking in 2021. In a note to investors, Stifel analysts said they supported the decision to wind down the unit by the end of 2024, predicting it will benefit revenue growth and profitability and increase focus at the company. Dive Insight Livanova expanded its circulatory support offering by acquiring Tandemlife for $200 million upfront in 2018 and received 510(k) clearance for Lifesparc the next year. ASC remained a small part of the broader business, though. Over the first nine months of last year, ASC brought in $30.2 million, almost exclusively in the U.S., and accounted for about 4% of total sales. The unit has contracted in recent years. ...
Pharmaceutical Executive Editorial Staff SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 is being evaluated in an ongoing Phase I/II study in combination with Venclexta and Vidaza for patients with relapsed or refractory acute myeloid leukemia. The FDA has granted Fast Track Designation to SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML). The regulatory action was based on safety and efficacy data for the drug, which is being evaluated in an ongoing Phase I/II study (NCT04588922) in combination with Venclexta (venetoclax) and Vidaza (azacytidine) for patients with AML. “Receiving fast track designation for SLS009 for relapsed or refractory AML, following the recent orphan drug designation for the same indication, underscores the potential for SLS009 and highlights the critical unmet need for patients with AML who face a poor prognosis due to the progressive nature of the disease,” ...
SHANGHAI, Jan. 07, 2024 /PRNewswire/ — Shanghai Argo Biopharmaceutical Co., Ltd. (“Argo”), a biotechnology company focused on the discovery and development of next-generation RNAi therapeutics, today announced that it has entered into two exclusive license and collaboration agreements with Novartis PHARMA AG (“Novartis”). Under the first agreement, Argo has granted Novartis exclusive global licenses to develop and commercialize a Phase 1 stage program. The first agreement also includes a research collaboration and Novartis also receives an option to potentially license compounds directed against up to two additional targets for cardiovascular disease treatment. Under the second agreement, Argo granted Novartis an exclusive ex-Greater China license to develop and commercialize a Phase 1/2a clinical-stage program for cardiovascular disease treatment. Discovered and developed with Argo’s cutting-edge RNAi platform technology, these clinical-stage assets offer industry-leading efficacy and durability therapies. The transactions have a combined potential value of up to $4.165 billion for Argo and ...
Recently, Hengrui Pharmaceuticals’ subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received the Certificate of Drug Registration approved for issuance by the State Drug Administration, approving the company’s self-developed Hengrui Pharmaceuticals Metformin Extended-Release Tablets (I) (II) (Ruicinda®) for marketing, which, together with dietary control and exercise, is applicable to adult patients with type 2 diabetes mellitus (T2DM) who are suitable for receiving treatment with Hengrui Pharmaceuticals and Metformin, in order to improve the glycemic control of such patients. This marks the successful launch of China’s first self-developed sodium-glucose cotransporter protein 2 inhibitor (SGLT2i) combined with metformin in a fixed-complex, extended-release formulation, which will bring more convenience to T2DM patients in China. Diabetes mellitus has become the third chronic disease that seriously endangers human health after tumor and cardiovascular disease. At present, China has become the first country with diabetes, in which patients with type 2 diabetes mellitus (T2DM) have a progressive decline ...
Announcing a new article publication for Cardiovascular Innovations and Applications journal. Cryoablation (CRYO) is a novel catheter ablation technique for atrial fibrillation (AF). However, uncertainty persists regarding the role of metabolic modifications associated with CRYO. This study was aimed at exploring whether CRYO influences the metabolic signature – a possibility not previously investigated. Paired serum samples from patients with AF (n = 10) were collected before and 24 h after CRYO. Untargeted metabolomic analysis was conducted with LC-MS. Univariate and multivariate analyses were applied to identify differential metabolites between samples. Pathway enrichment and Pearson correlation analyses were performed to reveal the perturbed metabolic pathways and potential interactions. Levels of 19 metabolites showed significant changes between baseline and 24 h after CRYO. Pathway analysis revealed that the perturbed metabolites were enriched in unsaturated fatty acid biosynthesis, retrograde endocannabinoid signaling, and neuroactive ligand-receptor interactions. Pearson correlation analysis indicated strong correlations among differential ...
Announcing a new article publication for Cardiovascular Innovations and Applications journal. Risk prediction models are an important part of assessing operative mortality and postoperative complication rates in current cardiac surgery practice. Furthermore, they guide clinical decision-making and perioperative patient management. In recent years, a variety of clinical prediction models have been developed in China and other countries to assess the risk of mortality and complications after cardiac surgery. Currently, the most widely used and mature models are the new version of the European Cardiac Surgery Evaluation System (EuroSCORE II), the American Society of Thoracic Surgeons Cardiac Surgery Risk Model (STS score), and the Chinese Coronary Artery Bypass Graft Surgery Risk Evaluation System (SinoSCORE). This article reviews the application of these three risk prediction models, to identify the optimal model for guiding clinical practice. Source: https://www.news-medical.net/news/20240105/Precision-surgery-powered-by-prediction-Optimizing-patient-care-with-the-best-risk-scores.aspx
After a dispute over milestone payments derailed a 2019 heart med collaboration, Daiichi Sankyo and Esperion Therapeutics have mended fences with a $125 million settlement. Under the new agreement, Daiichi will pay Esperion $100 million in the coming weeks before an anticipated label expansion in Europe for their bempedoic acid products Nilemdo and Nustendi, which are branded as Nexletol and Nexlizet, respectively, in the U.S. The company will pay a further $25 million in the quarter following the European Medicines Agency’s (EMA) decision on whether to add language about a cardiovascular risk reduction to the drug’s label. Meanwhile, European manufacturing and supply responsibilities will change hands from Esperion to Daiichi, which will deliver “significant cost savings and efficiencies” to both companies, the partners said in a joint press release. Going forward, the two companies will expand their collaboration to potentially work on a triple-formulation product using bempedoic acid. Daiichi will ...
Novartis is paying Voyager Therapeutics $100 million up front to collaborate on gene therapies for Huntington’s disease and spinal muscular atrophy. The deal builds on a relationship the companies started in 2022. By FRANK VINLUAN Novartis is committing $100 million to Voyager Therapeutics to see if the biotech’s technology can lead to new gene therapies for Huntington’s disease and spinal muscular atrophy. According to deal terms announced Tuesday, the sum is an upfront payment that includes a $20 million equity investment in Voyager. Milestone payments could bring the Lexington, Massachusetts-based biotech up to $1.2 billion more. If the partnership leads to commercialized therapies, Voyager would also receive royalties from sales. Gene therapies reach their bodily destinations carried aboard an engineered virus. The therapy’s genetic cargo is enveloped by a protein shell called a capsid. Voyager’s TRACER technology platform discovers capsids that can target particular types of tissue. In addition to ...
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