As one of the first hospitals to enter the Boao Lecheng International Medical Tourism Zone in Hainan, the Boao International Hospital of Jimin Health, relying on the policy advantage of “early and pilot implementation” of the zone, has focused its R&D efforts on two major R&D pipelines of adipose-derived mesenchymal stem cells and dendritic cells in the field of cellular therapeutic drugs. Tian Yunfei, director and president of Jimin Health, recently said in an interview with China Securities Journal, “Based on the long-term optimism for the development prospect of cell therapy drugs, Jimin Health will focus on the research and development of Boao International Hospital’s cell therapy drug pipeline in the future.” Joining hands with stem cell experts JiminHealth’s 2024 semi-annual report disclosed the appointment of Jonathan Robert Lakey as the chief scientist of the International Regenerative Medicine Research Center of Boao International Hospital, a controlling subsidiary, and that the ...
Beijing Drug Administration held a half-year working meeting, at which the work of issuing the country’s first stem cell “drug production license” was particularly recognized. According to the search results of “Administrative License Information” on the website of Beijing Drug Administration, Platinum Bio-Excellence Biotechnology (Beijing) Co., Ltd. is the first company to obtain the national stem cell drug production license. The issuance of the Drug Manufacturing License is of epoch-making significance as it is the first drug manufacturing license specifically for stem cell drugs in China. The issuance of the Drug Manufacturing License signifies that the relevant enterprise has obtained the legal qualification and ability to manufacture stem cell drugs. In recent years, with the introduction of policies such as the “14th Five-Year Plan” for the development of bio-economy, China has clearly put forward the development of new technologies such as stem cell therapy, strengthening the synergy between industry, academia, ...
In the field of cardiovascular health, some individuals fall into an ambiguous “intermediate zone” of risk for heart attacks or strokes—neither distinctly low nor high-risk, yet potentially on the cusp of heart disease. This grey area calls for improved methodologies for accurate risk prediction. Traditionally, risk assessments like the widely recognized Framingham Risk Score have utilized factors such as levels of ‘good’ and ‘bad’ cholesterol to categorize individuals into risk groups. However, these conventional tools have several limitations, especially in identifying the risks for those in this intermediate category. This oversight is particularly critical as heart disease can progress silently, making early detection crucial to avoid late-stage interventions that are less effective. Now, scientists have developed and validated a novel, blood-based risk score based on lipids (fats in the blood). The tool, outlined in a paper published in the Journal of the American College of Cardiology, was developed by scientists ...
Age is a significant factor for many common chronic diseases, yet it does not perfectly represent the actual biological aging processes that drive multimorbidity and mortality. Biological aging can be more accurately assessed by using ‘omics data, which reflects an individual’s biological functions relative to their chronological age. Traditionally, biological aging clocks have relied on DNA methylation, but protein levels might offer deeper insights into the mechanisms of aging. Researchers have now created a machine learning-based blood test that evaluates over 200 proteins to determine a person’s biological aging rate. This test is designed to predict the risk of developing 18 major age-related diseases and the likelihood of premature death. The machine learning model that uses blood proteomic information to estimate a proteomic age clock was developed by researchers at Massachusetts General Hospital (Boston, MA, USA) in a large sample of participants from the UK Biobank. Its validity was further ...
Medicare’s physician fee schedule includes billing codes for digital therapeutics for the first time. Stakeholders say these codes could help turn around reimbursement challenges weighing on the entire digital medicines sector. By Frank VinluanWhen the FDA approves a drug, passing that regulatory bar of safety and efficacy puts it on the path toward likely reimbursement by government and commercial payers. The same has not been true for digital therapeutics. A proposal from the Centers for Medicare and Medicaid Services signals a change in federal thinking about such technologies, which could pave the way for broader coverage of novel digital medicines. For the first time, CMS’s proposed physician fee schedule, a comprehensive annual listing of the fees that Medicare uses to pay doctors, now includes digital therapeutics. The proposal does not cover all digital therapeutics under multiple benefit categories, as the Digital Therapeutics Alliance (DTA) had asked nearly a year ago. ...
By Don Tracy, Associate Editor Approval of Livdelzi is based on results from the Phase III RESPONSE study, which demonstrated improved key biochemical markers and reduced pruritus. The FDA has granted accelerated approval to Livdelzi (seladelpar), Gilead’s treatment for primary biliary cholangitis (PBC) in adults who either have an inadequate response to ursodeoxycholic acid (UDCA) or cannot tolerate it. According to the company, the approval was based on positive results from the Phase III RESPONSE study, where Livdelzi significantly improved key biochemical markers and reduced pruritus, a debilitating symptom of PBC. Accelerated approval was based on a reduction of ALP.1 “More people are being diagnosed with PBC, impacting people of varied ages, gender, race and ethnicity. Those living with PBC share common symptoms, including incessant itching or skin-crawling sensations, as well as debilitating fatigue that is made worse by the itching at night,” said Carol Roberts, president, The PBCers Organization, ...
The first 10 drugs selected for Medicare price negotiations now have new prices set to take effect in 2026. Industry observers note that most of these drugs are older products facing generic competition soon, so greater industry impact will come as the program expands to more drugs in years to come. By Frank VinluanMedicare has unveiled prices for the first 10 drugs selected for its negotiation program, resulting in discounts of as much as 79% off of list prices. Taxpayers will save an estimated $6 billion, the White House said in a Thursday announcement of the new prices. The savings won’t happen right away. New pricing for these products won’t take effect until Jan. 1, 2026 for those with Medicare Part D prescription drug coverage. But these 10 widely used products in therapeutic areas such as diabetes and autoimmune disorders represent the first of many drugs on a path to ...
By Don Tracy, Associate Editor The FINEARTS-HF study, which compared Kerendia to a placebo when added to standard therapy, met its primary endpoint by reducing cardiovascular death and total heart failure events. Results from the Phase III FINEARTS-HF study found that Bayer’s Kerendia (finerenone) demonstrated significant efficacy in treating heart failure patients with a left ventricular ejection fraction (LVEF) of 40% or greater. According to the company, the study met its primary endpoint by significantly reducing the composite measure of cardiovascular death and total heart failure events, including both hospitalizations and urgent visits for heart failure.1 “We are very excited by the positive results from the FINEARTS-HF study,” said Christian Rommel, PhD, head of Research and Development, Bayer’s Pharmaceuticals Division. “With limited options currently available for patients with this common form of heart failure with a mildly reduced or preserved ejection fraction, this news is hugely important for patients and ...
Bayer reported a Phase 3 test of Kerendia in heart failure led to statistically significant reductions in cardiovascular death and hospitalizations. Detailed results will be presented during the European Society of Cardiology annual meeting in September. By Frank Vinluan Bayer’s Kerendia, already FDA approved in one cardiometabolic indication, now has data from a pivotal test that support expanding the drug’s label to heart failure. In preliminary results reported Monday, Bayer said Kerendia reduced cardiovascular death and hospitalizations in heart failure patients, meeting the main goal of the Phase 3 clinical trial. The company did not release specific figures detailing the reductions, but said it will present the clinical data next month during the European Society of Cardiology Congress, which will be held in London. Bayer added that it plans to meet with the FDA to discuss a submission seeking regulatory approval for the drug in heart failure. Kerendia is a small ...
by Jen Brogan A study conducted by researchers from the National Cancer Institute (NIH) has revealed that non-statin cholesterol drugs could reduce the risk of liver cancer. Published in the American Cancer Society’s CANCER, researchers looked for associations between five types of non-stain cholesterol-lowering medications and the risk of liver cancer. Accounting for more than 700,000 deaths each year, liver cancer is the sixth most commonly occurring cancer globally and the third leading cause of cancer mortality. Non-statin cholesterol-lowering medications such as cholesterol absorption inhibitors, bile acid sequestrants, fibrates, niacin and omega-3 fatty acids all work in different ways and are prescribed to manage cholesterol and lipid levels. Using information from the Clinical Practice Research Datalink, which covers around 7% of the UK population, researchers analysed 3,719 liver cancer cases and 14,876 matched controls without cancer. Additional matches were also made based on patients’ type 2 diabetes and chronic liver ...
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