Search Results for “Clinical Trial” – Page 51 – media

【EXPERT Q&A】What is the specific process of medical device product registration?

Drugdu.com expert’s response: The medical device product registration certificate is a necessary credential for legal marketing and sales of medical device products. Its application process involves multiple stages, aiming to ensure the safety, effectiveness, and compliance of the products. Below is a detailed breakdown of the specific process for obtaining a medical device product registration certificate, divided into six phases. I. Preparation Before applying for registration, applicants need to thoroughly understand relevant national regulations and policies, including the “Regulations on the Supervision and Administration of Medical Devices” and the “Measures for the Administration of Medical Device Registration,” to ensure product compliance. At the same time, prepare necessary application materials, which include but are not limited to: 1.Enterprise Qualification Certificates: such as business licenses, medical device production licenses, etc. 2.Product Technical Data: detailing technical specifications, performance parameters, production processes, quality standards, etc. 3.Product Instructions: comprehensively describing usage methods, precautions, warning information, ...
- Source: drugdu
- 87
- July 29, 2024
Pfizer Hemophilia Gene Therapy Meets Phase 3 Goals, But Its Success Matters More to Sangamo

Pfizer’s hemophilia A gene therapy reduced annualized bleeding rates in a Phase 3 clinical trial, setting the stage for discussions with regulators. However, the market for such one-time treatments is uncertain, as uptake of commercialized hemophilia gene therapies remains slow. By Frank Vinluan A Pfizer gene therapy for hemophilia A reduced bleeding rates in patients with the inherited blood disorder, meeting goals of its Phase 3 study. The preliminary results announced Wednesday are measures taken at 15 months in a study that will follow patients for up to five years, meaning the one-time treatment’s durability remains an open question. The pharmaceutical giant now plans to meet with regulators to discuss next steps for the therapy. In hemophilia A, insufficient levels of a clotting protein called factor VIII make patients susceptible to frequent bleeding events. Treatment includes regular infusions of this clotting protein to prevent these events. The Pfizer gene therapy, giroctocogene fitelparvovec, delivers ...
- Source: https://medcitynews.com/author/fvinluan/
- 108
- July 27, 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
- 96
- July 24, 2024
Computational Tool Integrates Transcriptomic Data for Improved Breast Cancer Diagnosis and Treatment

Breast cancer is the most commonly diagnosed cancer globally, presenting in various subtypes that require precise identification for effective, personalized treatment. Traditionally, cancer subtyping has been conducted through histological staining (immunohistochemistry), which involves identifying specific markers that categorize tumors into distinct subtypes. Recently, high-throughput transcriptomic profiling has transformed the way breast cancer subtypes are identified by analyzing gene activity in cancer cells through the total messenger RNAs present, which correspond to gene sequences and are used by ribosomes to synthesize proteins. Transcriptomic profiling utilizes RNA sequencing (RNAseq), a rapidly evolving molecular biology technique that sequences RNA strands efficiently. As RNA sequencing becomes more affordable, it holds the potential for routine clinical integration to aid in diagnosis and treatment decisions. However, its application is currently limited by the requirement for processing large sample batches simultaneously and difficulties in comparing samples across different platforms. Now, scientists have developed a computational tool that ...
- Source: drugdu
- 69
- 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
- 75
- July 24, 2024
World’s First Rapid Diagnostic Test Detects Stroke within Minutes at POC

Each year, more than 20 million people worldwide suffer from strokes. Large vessel occlusions (LVO) constitute 30% of these cases but are behind 95% of the resulting disabilities and fatalities. The likelihood of recovery improves significantly if a procedure known as ‘thrombectomy’ is performed immediately after the onset of symptoms. However, speeding up this treatment is complicated because it’s difficult to identify LVO strokes outside hospital settings; symptoms can mimic other medical issues. Strokes can also result from blockages in smaller vessels or vessel ruptures, neither of which are suitable for thrombectomy. Ideally, LVO strokes need to be diagnosed quickly and before the patient arrives at the hospital to speed up the initiation of thrombectomy. Currently, there is no sufficiently accurate diagnostic tool for this purpose. Now, a groundbreaking diagnostic test can identify an LVO stroke within 15 minutes, expediting patient transfer to specialized care and saving more than 1 ...
- Source: drugdu
- 114
- July 23, 2024
Artiva’s IPO Reels In $167M to Bring NK Cell Therapy to Autoimmune Diseases

Lupus is the lead autoimmune indication for Artiva Biotherapeutics, which has an early-stage clinical trial underway. Artiva’s allogeneic cell therapies are based on natural killer cells. By Frank VinluanCell therapy first reached patients as treatments for cancer. Artiva Biotherapeutics is part of a growing group of companies working to bring cell therapy to autoimmune disease, and its IPO has raised $167 million for clinical trial plans. Artiva priced the IPO at $12 per share, which was below the $14 to $16 per share price range the biotech set in preliminary terms last week. However, it boosted the deal size by increasing the number of shares in the offering. The 8.7 million shares it initially planned to offer would have raised $130.5 million at the proposed pricing midpoint. The company was able to raise more by selling 13.92 million shares. The shares of San Diego-based Artiva shares debuted on the Nasdaq ...
- Source: drugdu
- 71
- July 23, 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
- 88
- 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
- 73
- July 22, 2024
EMA accepts Deciphera’s MAA cell tumour treatment for review

The European Medicines Agency (EMA) has accepted for review the marketing authorisation application (MAA) of Ono Pharmaceutical subsidiary Deciphera Pharmaceuticals‘ vimseltinib to treat tenosynovial giant cell tumour (TGCT). Vimseltinib is a colony-stimulating factor 1 receptor (CSF1R). The review will be carried out under the centralised review process of the European regulator for all 27 member states of the European Union (EU), Iceland, Norway and Liechtenstein. The MAA filing is based on the findings of the Phase III MOTION clinical trial assessing the safety and efficacy of vimseltinib in people with TGCT not amenable to surgical procedure without previous anti-CSF1/CSF1R therapy, versus placebo. The study showed a significant objective response rate (ORR) at week 25 – the trial’s primary endpoint – compared to placebo. Secondary endpoints of the study included ORR per tumour volume score, active range of motion, physical function and quality of life assessments. Vimseltinib also showed a manageable ...
- Source: drugdu
- 59
- July 22, 2024

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