Search Results for “FDA” – Page 84 – media

Domestic PD-1 accelerates landing in Europe and America! Junshi and Baekje are rushing to the beach, and the next one is Hengrui?

Recently, BeiGene announced that its PD-1 inhibitor Trastuzumab (US trade name: TEVIMBRA) has been officially commercialized in the United States for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously received systemic chemotherapy (excluding PD-1/L1 inhibitors). Global pharmaceutical companies consider the US market as a battleground for going global. At the end of October 2023, Junshi Biotech’s trastuzumab (US trade name: LOQTORZI) obtained FDA approval, becoming the first nasopharyngeal carcinoma drug to be marketed in the United States, as well as the first biologically innovative drug and PD-1 inhibitor from China approved by the FDA. In March 2024, BeiGene’s Trastuzumab was approved for its first indication in the United States, following closely behind. After more than six months of FDA approval, Trastuzumab has finally been officially launched for sale in the United States. In the industry’s view, Chinese pharmaceutical companies such as ...
- Source: drugdu
- 59
- October 11, 2024
Another new analgesic has been submitted for marketing application

Vertex (Futai Pharmaceuticals) has a long-standing reputation. It has worked in the field of rare diseases for more than ten years and has created an orphan drug blockbuster trikafta with annual sales of over $10 billion. Today, the company has opened up new horizons in another field. Recently, Vertex announced that the FDA has accepted the marketing application of the Nav1.8 inhibitor VX-548 (Suzetrigine) and granted priority review qualification for the treatment of moderate to severe acute pain. This is a major breakthrough in the field of analgesics and may subvert the competitive landscape of analgesics commercialization. Analgesics have always been valued by the medical community, both in academia and industry. And every pharmacology textbook and medicinal chemistry textbook used as a teaching material cannot avoid a classic drug: morphine. Whether it is its rigid structure of five fused rings or its analgesic and antitussive pharmacological effects, it is well ...
- Source: drugdu
- 63
- October 11, 2024
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
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
【EXPERT Q&A】How to obtain the 510K number for medical device export to the United States?

Drugdu.com expert’s response: Exporting medical devices to the United States and obtaining a 510K number involves adhering to the regulations and procedures set forth by the U.S. Food and Drug Administration (FDA). Ⅰ. Understanding the Basics of 510K 510(k) is a premarket notification program established by the FDA, named after Section 510(k) of Chapter 21 of the Federal Food, Drug, and Cosmetic Act. This program requires manufacturers to submit a “510(k) Premarket Notification” to the FDA before introducing a new medical device or making significant modifications to an existing one and reintroducing it to the market. The purpose of this submission is to demonstrate that the newly developed medical device is substantially equivalent in safety and effectiveness to a similar device that has already been approved by the FDA. Ⅱ. Determining Product Classification First, it is essential to determine the classification of the medical device. The FDA categorizes medical devices ...
- Source: drugdu
- 75
- October 7, 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
Digital therapeutics are a big failure

The digital therapeutics industry has evolved and evolved beyond all expectations. In June 2021, Pear Therapeutics, the “first stock of digital therapeutics”, was listed; In April 2023, he filed for bankruptcy and bankruptcy; A year later, Better Therapeutics, another star digital therapeutics company, also fell; Four months ago, Akili chose to sell himself and delist and go private. So far, the three musketeers of overseas digital therapeutics have all fallen. If you count from the listing of Pear, a three-year cycle, the waves will sweep away the heroes. On the surface, the main reason for the collapse of these companies is financial problems, but the deeper reason is the commercialization challenges faced by digital therapeutics. The challenge is that digital therapeutics need to have drug-like efficacy in order to gain market acceptance, but the embarrassment is that prescription digital therapeutics are not drugs per se, but more about using technical ...
- Source: drugdu
- 57
- 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

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