Search Results for “Clinical Trial” – Page 40 – media

Let’s go to Europe to seek gold

It is a general trend for pharmaceutical companies to go overseas, and the proposition of the times behind it is also advancing with the times. Under the new changes, how to re-examine the gold-mining places such as the United States, Europe, and Southeast Asia? Different countries and regions have different market sizes and policies and regulations. How to examine the pros and cons of the market and formulate a more suitable strategy for going overseas? Everything needs to be answered by the industry. At present, more and more signs show that pharmaceutical companies are no longer just focusing on the “fat meat” of the US market as in the past, and countries and regions such as Europe are becoming more and more important. After being hit repeatedly by the FDA, more and more PD-1s have moved to Europe and been approved for listing. Since the beginning of this year, domestic ...
- Source: drugdu
- 64
- October 10, 2024
The 2024 “Most Promising New Talent in Biopharmaceuticals” list has been released!

Recently, well-known industry media Endpoint News released the “Biopharma’s Most Exciting Startups in 2024” list, which includes 11 biotechnology companies. These emerging research fields include gene editing, immunotherapy, antibody conjugated drugs (ADCs), weight loss therapy, and multiple other directions. This article will introduce these 11 rising stars (listed in no particular order) to readers, based on this ranking and official information from various companies. Lifordi Immunotherapies is a biotechnology company dedicated to developing ADC therapies for the treatment of autoimmune and inflammatory diseases. Lifordi was founded in 2023 and has secured $70 million in Series A funding from ARCH Venture Partners, 5AM Ventures, and Atlas Venture, with the goal of advancing the main candidate drug LFD-200 into clinical trials and obtaining preliminary data by the end of 2025. Lifordi’s main ADC therapy LFD-200 targets myeloid cells and lymphocytes by targeting highly internalized cell surface facial mask proteins. This therapy has ...
- Source: drugdu
- 80
- October 9, 2024
【EXPERT Q&A】What is the South African drug export registration process?

Drugdu.com expert’s response: The process of exporting and registering pharmaceutical products in South Africa is a relatively complex and meticulous endeavor, involving multiple stages and documentation requirements. Here is an overview of the process: Ⅰ. Preliminary Preparation Product Classification: Firstly, it is crucial to determine the classification of the pharmaceutical product in South Africa, as different classifications may entail different registration requirements and procedures. Preparation of Technical Documentation: This typically includes detailed information about the product, such as its composition, indications, dosage form, quality standards, as well as technical specifications, design descriptions, and performance test results that demonstrate the product’s safety, efficacy, and performance. Collection of Clinical Data: Depending on the requirements, relevant clinical data must be provided to support the product’s clinical performance and effectiveness. This may encompass clinical trial results, case studies, literature reviews, etc. Corporate Qualification: Ensure that the exporting company has a legal registration status in ...
- Source: drugdu
- 74
- October 9, 2024
Electrophysiology, giants dance wildly

The existing electrophysiology market is very considerable, and the incremental market has unlimited potential. Research institution BTIG predicts that half of atrial fibrillation ablations may be replaced by PFA in the next three years. In the new business of PFA, electrophysiology giants dare not be tired at all. Recently, Boston Scientific announced that it has obtained approval from Japanese regulators for the FARAPULSE™ pulsed field ablation system. Nick Spadea-Anello, president of Boston Scientific Electrophysiology, said that the FARAPULSE PFA system is the most clinically studied PFA system. To date, it has been used to treat more than 125,000 patients worldwide and continues to strengthen its strong safety, effectiveness and efficiency characteristics. “The rapid adoption of the FARAPULSE PFA system, which is now approved in more than 65 countries, demonstrates a paradigm shift in the treatment of paroxysmal atrial fibrillation – an approach that has clinical benefits for both physicians and ...
- Source: drugdu
- 70
- October 8, 2024
What is the impact of the House of Representatives’ passage of the draft biosafety law amid the controversy on WuXi

On September 9, the House of Representatives of the United States Congress returned from a summer break and immediately scheduled a series of legislative votes, including the draft Biosafety Act (H.R. 8333). The draft biosecurity law passed the House of Representatives with 306 votes in favor and 81 votes against, but the 70% support rate made it the most divisive draft bill in the same batch, and even narrowly fell below the “bottom line” of more than two-thirds of the votes to pass the bill. The draft Biosafety Act places five companies, including WuXi AppTec and WuXi Biologics, on the list of “biotechnology companies of concern” on the grounds of “national security”, and intends to restrict the use of funds, loans or subsidies from the United States government to cooperate with these companies. Unlike previous committees that voted in small groups, this time there were several members of the House ...
- Source: drugdu
- 71
- October 6, 2024
The old mechanism of “using drugs to support doctors” has been broken

Recently, the State Council Information Office held a series of press conferences on “Promoting High-quality Development”. The leadership of the National Health Commission answered many questions in the field of domestic medicine and health at the meeting. When introducing the basic situation, Lei Haichao, director of the National Health Commission, said that the National Health Commission adheres to the public welfare and works with relevant departments to deepen the medical reform. Over the past decade, especially since the 18th National Congress of the Communist Party of China, the old operating mechanism of using drugs to support doctors and consumables to support doctors has been historically broken, and a new operating mechanism dominated by medical services has been initially established. The income of public medical institutions has changed from the original three channels to two channels of government financial subsidies and medical service charges. “The old mechanism of relying on ...
- Source: drugdu
- 92
- October 5, 2024
The China Securities Regulatory Commission encourages cross-border mergers and acquisitions of unprofitable assets, and a new path for Biotech to land in the capital market?

Wu Qing, chairman of the China Securities Regulatory Commission, said at a press conference of the State Council that in order to further stimulate the vitality of the M&A and restructuring market, the CSRC has studied and formulated the “Opinions on Deepening the Reform of the M&A and Restructuring Market of Listed Companies” (“M&A Six”, hereinafter referred to as the “Opinions”), including supporting the transformation and upgrading of listed companies in the direction of new quality productivity, encouraging industrial integration, improving regulatory tolerance, and improving the transaction efficiency of the restructuring market. Among them, it is clear that it will vigorously support listed companies to carry out cross-industry mergers and acquisitions and acquisitions of unprofitable assets based on transformation and upgrading. This means that unprofitable biotech companies may usher in a new path to land in the capital market. At the meeting, Wu Qing said that mergers and acquisitions are ...
- Source: drugdu
- 64
- October 5, 2024
Optimization strategy for production process of RNA targeted drugs

RNA targeted drugs are a completely new category of drugs that are completely different from small molecule drugs and antibody drugs. On the one hand, they can target mRNA, ncRNA, and other intracellular proteins through gene silencing to inhibit their expression and achieve the goal of treating diseases; On the other hand, new generation vaccines and protein replacement therapies can also be developed based on mRNA. RNA targeted drugs are undoubtedly a strategic frontier in biopharmaceutical innovation, with broad potential application scenarios in the future. The production process technology of mRNA industrialization is particularly important for the widespread application and industrialization of mRNA. Based on this, this article will focus on the optimization strategies for the production process of RNA targeted drugs. Stability chemical modification enhances drug safety and efficacy For RNA targeted drugs, chemical modification (excluding tissue targeting ligands) mainly has two basic functions: firstly, chemical modification can significantly ...
- Source: drugdu
- 82
- October 3, 2024
Seven domestic companies have completed a new round of financing, focusing on the fields of cell and gene therapy

In September, several domestic companies focused on the field of cell and gene therapy (CGT) announced progress in financing. This article will share basic information about its 7 companies based on publicly available materials. Xingsairui has successfully completed tens of millions of yuan in angel round financing On September 14th, Hangzhou Xingsai Ruizhen Biotechnology Co., Ltd. (hereinafter referred to as “Xingsai Ruizhen”) announced the completion of tens of millions of yuan in angel round financing and officially launched the angel+round financing plan! This round of financing is jointly invested by Fosun Pharma’s Rehabilitation Capital New Drug Innovation Fund and Chuangrui Investment Jiaxing Chuangyan Fund. This round of financing will be used for the continuous promotion of core pipelines and platforms, as well as the construction of the company’s team and research and development laboratories. Xingsai Ruizhen was founded in July 2022 and incubated by the New Drug Innovation ...
- Source: drugdu
- 88
- October 3, 2024
Record-breaking advance payments for going overseas, and new changes in breast cancer

Since the discovery of cyclin-dependent kinases (CDKs), scientists have been trying to target them to disrupt cancer cell division and proliferation. Breast cancer in particular relies on this process to grow. Because of this, the first-generation CDK inhibitors targeting CDK4 and CDK6 have been very successful. In February 2015, palbociclib, the first CDK4/6 inhibitor developed by Pfizer, was approved for marketing in the United States for the treatment of locally advanced or metastatic breast cancer of HR/HER2-. There are many breast cancer patients, and in 2020, there were more than 2.3 million new breast cancer patients in the world, making it the world’s largest cancer type. Based on the large patient size, the sales scale of palbociclib is also considerable. In 2016, the sales of palbociclib in the first full year of marketing reached 2.135 billion US dollars, becoming a well-deserved blockbuster drug. Since then, CDK4/6 inhibitors of Eli ...
- Source: https://mp.weixin.qq.com
- 86
- October 3, 2024

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