A lack of sleep has been linked to high blood pressure and other cardiovascular ailments, mental health conditions like depression and weight-related issues such as obesity and diabetes.
FITBIT SPENT ITS first decade selling activity trackers. With its latest moves, the company is starting to look less like a gear maker selling pricey accessories to fitness buffs and more like a medical-device company, catering to hospitals, patients, and health insurers. The company’s business-to-business arm, called Health Solutions, is now addressing four health conditions—sleep disorders including sleep apnea, diabetes, cardiovascular health and mental health—for employers, health insurers, healthcare providers, and researchers.
Sometimes even the experts need a little help staying holly and jolly. Research shows holiday season stress can feel insurmountable. No one is immune. Mental health professionals, who are usually helping others manage emotions, put their own advice into practice as the year winds down.
A report released by the World Health Organization in 2017 mentioned that about 322 million people suffer from depression worldwide; according to the “2022 National Depression Blue Book”, the number of people suffering from depression in my country is as high as 95 million, but the treatment rate is only 9.5%. As social pressure increases, more and more people have mental health problems, the number of patients with depression continues to increase, and the demand for antidepressants continues to increase. According to Grand View Research, the global antidepressant market size will reach US$60 billion in 2028. At present, although there are many antidepressants available clinically, most drugs still have defects such as slow onset, low efficiency, and even sexual dysfunction and cognitive impairment. Therefore, patients still need more new and effective antidepressants. LPM682000012 is a Class 1 new drug declared by Luye Pharmaceuticals. The indication for clinical trials approved this ...
Drugdu.com expert’s response: Ⅰ. GMP Certification Concept GMP, an acronym for GOOD MANUFACTURING PRACTICE, signifies “Good Manufacturing Practices” in Chinese. The World Health Organization defines GMP as a regulation guiding the production and quality management of food, pharmaceuticals, and medical products. GMP is a mandatory standard applicable to industries such as pharmaceuticals and food, requiring enterprises to meet hygiene quality requirements in terms of raw materials, personnel, facilities and equipment, production processes, packaging and transportation, and quality control, in accordance with relevant national regulations. It forms a set of operable operational norms to help enterprises improve their hygiene environment and promptly identify and rectify issues in the production process. GMP mandates that pharmaceutical and food production enterprises possess good production equipment, reasonable production processes, comprehensive quality management, and rigorous testing systems to ensure that the final product quality (including food safety and hygiene) meets regulatory requirements. In the pharmaceutical production ...
On September 26, the field of schizophrenia ushered in a historic moment, when KarXT developed by Karuna was approved by the FDA for marketing. This means that Bristol-Myers Squibb’s tens of billions of bets have succeeded in their first battle. On December 22 last year, Bristol-Myers Squibb spent $14 billion to acquire Karuna for KarXT. KarXT has been approved for marketing, and there is another winner – Zai Lab. Currently, Zai Lab owns the rights to KarXT in Greater China. Considering that there are more than 8 million schizophrenia patients in China, and the introduction cost of Zai Lab is not high, it is expected to obtain sufficient profits. Of course, all this can only be said to have settled, and is not surprising. Most of the existing schizophrenia treatments are old varieties approved in the 1990s. KarXT does not rely on dopaminergic or serotonergic pathways and is the first ...
Recently, the drug marketing authorization application for the JAK1 inhibitor amaxitinib sulfate tablets (SHR0302 tablets) was accepted by the State Food and Drug Administration. This product is suitable for adult patients with severe alopecia areata. At present, no JAK1 inhibitor self-developed by domestic companies has been approved for marketing. In addition to the indications for alopecia areata, the marketing authorization application for Amaxitinib Sulfate Tablets has been accepted by the State Food and Drug Administration for three indications, namely: moderate to severe atopic dermatitis in adults and adolescents aged 12 years and above, and ankylosing spine. inflammation and moderate to severe active rheumatoid arthritis. In June 2024, the main research endpoint of the Phase III clinical trial of Emmaxitinib Sulfate Tablets reached the superiority standard preset in the protocol. This study is a randomized, double-blind, and placebo-controlled Phase III study to evaluate the effectiveness and safety of amaxitinib sulfate tablets ...
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. ...
The British Heart Foundation (BHF) has awarded five research projects more than £800,000 as part of its Healthcare Innovation Awards to improve the delivery of vital healthcare for patients. Comprising artificial intelligence (AI) and stethoscopes to offer digital access to mental health services to those living in remote areas, the projects will receive between £100,000 and £300,000 via the Healthcare Innovation Fund (HIF). Cardiovascular diseases (CVD) affect around seven million people in the UK, including coronary heart disease, the most common form of heart and circulatory disease, which affects around 2.3 million people in the UK. The HIF supports research that aims to explore and improve existing services and care for people living with heart conditions across the UK. Researchers from Imperial College London, Hull York Medical School, Leicester University Hospital, Jubilee University National Hospital and the University Hospital of Wales have been selected to receive the funding. The research ...
By Don Tracy, Associate Editor Erzofri is the first patented paliperidone palmitate long-acting injectable developed in China to receive FDA approval for treating schizophrenia and schizoaffective disorder, company says. Image Credit: Adobe Stock Images/Mohammad Xte The FDA has approved Luye Pharma Group’s Erzofri (paliperidone palmitate) extended-release injectable suspension for treating schizophrenia and schizoaffective disorder in adults. According to the company, the treatment is the first patented paliperidone palmitate long-acting injection developed in China to be approved in the United States. The product was granted a US patent in 2023, set to expire in 2039, and was approved as a new drug under the 505(b)(2) pathway.1 The approval is based on results from the company’s pivotal United States study of Erzofri.1 “The purpose of developing innovative formulations is to address unmet clinical needs, which includes covering aspects such as drug efficacy, compliance issues and side effects, among others. With a focus on ...
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