Search Results for “EU” – Page 11 – media

KCL study finds cell ageing could reveal early signs of neurodegenerative disease

Researchers from King’s College London (KCL), along with other collaborators, have found that ageing cells could reveal early signs of neurodegenerative diseases, including Alzheimer’s disease or amyotrophic lateral sclerosis. Published in Aging Cell, the findings could provide a wider picture of a target area for drugs and could improve treatments for these types of conditions. Affecting more than one million people in the UK, neurodegenerative conditions, such as multiple sclerosis and Parkinson’s disease, occur when cells of the central nervous system stop working or die. Using fluorescence to measure the viscosity of neuronal cytoplasm, the fluid enclosed by the cell membrane of the neuron, in mice, researchers found that the viscosity of the cytoplasm in the neuron (soma) increased as the mice aged. However, it did not increase in the cytoplasm of the axon, a tail-like structure that transmits electrical and chemical signals to other cells. Researchers suggested that the ...
- Source: drugdu
- 61
- July 30, 2024
EMA backs Wegovy cardiovascular label update as Novo seeks EU coverage

The European Medicines Agency (EMA) has offered a positive opinion to Novo Nordisk, which should pave the way for the company to update the label for its blockbuster weight loss drug Wegovy (semaglutide 2.4mg). The new label will reflect the therapy’s positive effects on cardiovascular health, potentially improving its chances for reimbursement in Europe. Under the new label, healthcare providers will be able to prescribe Wegovy to patients to reduce the risk of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal heart attack or non-fatal stroke in adults with established cardiovascular disease. If approved, this will be available for patients who are overweight or obese (initial BMI ≥27kg/m²) without having diabetes. The EMA’s Committee for Medicinal Products for Human Use (CHMP) supported the label update based on data from the Phase III SELECT (NCT03574597) study. The trial demonstrated that Wegovy decreased the incidence of MACE, in a statistically significant ...
- Source: drugdu
- 93
- July 29, 2024
ANKE Bio received clinical approval for another therapeutic mRNA vaccine

ANKE Bio (Group) Co., Ltd. and Hefei Alfana Biotechnology Co., Ltd. jointly developed a Class 1 new drug that received clinical approval from the Drug Administration (Drug Clinical Trial Approval Notification: 2024LP01608), with an indication for the treatment of cervical intraepithelial neoplasia. It is reported that this is the first therapeutic mRNA vaccine approved for clinical use in cervical intraepithelial neoplasia in China. Pre-cancerous lesions and their eventual malignant changes caused by viral infections are a serious threat to people’s lives and health. Globally, approximately 600 million people are infected with human papillomavirus (HPV), in addition to approximately 250 million people infected with hepatitis B virus (HBV), and 71 million people infected with hepatitis C virus (HCV). People infected with each of these viruses face a potential cancer risk. For example, approximately 30 million women are diagnosed each year with cervical intraepithelial neoplasia (CIN), an important precursor to cervical cancer. ...
- Source: drugdu
- 82
- July 25, 2024
【EXPERT Q&A】What are the dilemmas facing the pharmaceutical industry?

Drugdu.com expert’s response: The pharmaceutical industry faces numerous challenges, including: Ⅰ.High R&D Costs: Drug development is a lengthy and expensive process, often requiring billions of dollars and many years. The risk of failure is high, with many drugs not passing clinical trials. Ⅱ.Regulatory Pressure: Drug regulatory agencies (e.g., FDA, EMA) have increasingly stringent approval requirements for new drugs, necessitating more resources for clinical trials and data collection, thus increasing the difficulty and cost of bringing new drugs to market. Ⅲ.Short Patent Protection Period: The patent protection period for new drugs is relatively short. Once the patent expires, generic drugs quickly enter the market, significantly reducing the market share and profits of the original drug. Ⅳ.Intense Market Competition: The pharmaceutical market is highly competitive, not only from other innovative drugs but also from generic drugs and biosimilars. Ⅴ.Price Pressure: Governments and the public are increasingly concerned about drug prices, especially high-priced ...
- Source: drugdu
- 103
- July 24, 2024
Neuro Drug Passed Up by Biogen Posts Positive Data for Ionis, Setting Stage for Phase 3 Test

Ionis Pharmaceuticals is looking ahead to a Phase 3 study for an antisense medicine it is developing to treat Angelman syndrome, a rare neurodevelopmental disorder with no FDA-approved therapies. Its main competition is an Ultragenyx Pharmaceutical drug set to begin pivotal testing later this year. By Frank VinluanAn Ionis Pharmaceuticals drug in development for Angelman syndrome has mid-stage clinical trial results showing improvement across a range of measures of this rare neurodevelopmental disorder, and the company now plans to advance therapy to Phase 3 testing. Angelman is an inherited disorder that presents in infancy and leads to learning disability, muscle impairment, balance problems, and seizures. Patients typically develop little to no verbal ability. While Angelman patients can be treated with drugs that manage some of these symptoms, there are no FDA-approved therapies for the disease itself. The results announced Monday for the drug, ION582, come from the multiple-ascending dose portion of ...
- Source: drugdu
- 80
- July 24, 2024
Hengrui Pharmaceuticals’ Innovative Drug Dalsili, HRS-1358 Combination for Breast Cancer Approved for Clinical Trial

Recently, Hengrui Pharmaceuticals and its subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received the Notice of Approval for Clinical Trial of Drugs approved by the State Drug Administration, approving the company’s novel and highly selective CDK4/6 inhibitor, dalsiril hydroxyethanesulfonate tablets, combined with HRS-1358 tablets to carry out a clinical trial for breast cancer. Breast cancer is the number one malignant tumor affecting women worldwide. According to the Global Cancer Epidemiology Report 2024, the incidence and mortality rates of breast cancer rank first among female malignant tumors, with approximately 2.31 million new cases of breast cancer and 670,000 deaths globally each year, ranking first in terms of incidence and mortality rates of female malignant tumors [1]. In recent years, the incidence and mortality rates of breast cancer have shown a continuous upward trend in China, and it ranks fourth among the causes of cancer death. HRS-1358 is a novel, highly efficient and ...
- Source: drugdu
- 83
- July 24, 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
- 77
- July 22, 2024
FDA Clears Positrigo’s NeuroLF Brain PET System for the Diagnosis of Multiple Brain Disorders

By Don Tracy, Associate Editor Clearance of the NeuroLF Brain PET system marks Positrigo’s first device of its kind to be approved in the United States.The FDA has granted clearance to Positrigo’s NeuroLF brain positron emission tomographic (PET) system, which the company said represents a major advancement in functional brain imaging. The device is designed to diagnose and monitor brain disorders such as Alzheimer disease, brain tumors, epilepsy, and Parkinson disease. As the company’s first brain PET system approved in the United States, Positrigo is currently preparing for global market expansion, with European regulatory approval anticipated later this year.1 “It is not the first device of its kind which receives market clearance in the US, but we believe that our patient-centric and customer-driven design and development efforts over the last couple of years, brought us into the pole position to offer the best imaging solution to address the increased demand ...
- Source: drugdu
- 83
- July 20, 2024
FDA Grants Fast Track Designation to Abdera Therapeutics’ Treatment for Extensive-Stage Small Cell Lung Cancer

By Don Tracy, Associate Editor The novel therapy, ABD-147, uses advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, a protein found on neuroendocrine tumors. The FDA has granted Fast Track Designation to Abdera Therapeutics’ ABD-147, a next-generation precision radiopharmaceutical therapy designed for patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed following platinum-based chemotherapy. According to the company, ABD-147 implements advanced antibody engineering to deliver Actinium-225 to solid tumors expressing DLL3, which is a protein commonly found on neuroendocrine tumors but rarely expressed on the surface of normal cells or tissues.1 “Aggressive neuroendocrine cancers such as SCLC carry a poor prognosis and new treatment options are urgently needed,” said Lori Lyons-Williams, president, CEO, Abdera Therapeutics, in a press release. “These cancers have the most aggressive clinical course of any type of pulmonary tumor and often rapidly metastasize to other parts of the body. We are ...
- Source: drugdu
- 110
- July 19, 2024
Accounting Standards Committee of the Ministry of Finance Visited Fosun Pharmaceuticals to Conduct Research on Equity Method Project

Recently, Mr. Zhang Juan, Deputy Director of Accounting Standards Committee of the Ministry of Finance, and his team visited Fosun Pharmaceuticals’ Shanghai headquarters to conduct a special investigation on the equity method project, and Mr. Sun Mei, Partner of Ernst & Young’s Technology Department, participated in the investigation together. The research centered on the equity method project being carried out by the International Accounting Standards Board (IASB), and included research and exchanges on the practical application of the equity method on the enterprise side. Mr. Guan Xiaohui, Executive Director and Vice Chairman of Fosun Pharma, welcomed the delegation of the Accounting Standards Committee of the Ministry of Finance and believed that this exchange would help to improve the quality of the company’s accounting information and further understanding of accounting standards. Mr. Guan indicated that Fosun has always attached great importance to the compliance of financial information disclosure, and has continuously ...
- Source: drugdu
- 83
- July 18, 2024

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