Search Results for “FDA” – media

Johnson & Johnson’s first PFA product is approved by the FDA for marketing

Recently, Johnson & Johnson announced that it has obtained approval from the U.S. Food and Drug Administration (FDA) for its Varipulse pulsed field ablation system for the treatment of drug-refractory paroxysmal atrial fibrillation. After obtaining approval, Johnson & Johnson became the third company in the United States to have PFA technology for the treatment of AFib, joining the ranks of Medtronic and Boston Scientific, and the three-way competition in the PFA market has officially begun. It is understood that the Varipulse pulsed field ablation system consists of the Varipulse ablation catheter and the TRUPULSE generator. Among them, the VARIPULSE ablation catheter was developed based on Johnson & Johnson’s previous mapping catheter LASSO catheter, which is a continuation of the LASSO catheter technology, which further demonstrates Johnson & Johnson’s deep technical reserves in the catheter field. The Varipulse ablation catheter has 10 electrodes on the ring tip, and the ring tip ...
- Source: drugdu
- 40
- November 18, 2024
Johnson&Johnson’s first PFA product receives FDA approval for market launch

Recently, Johnson&Johnson announced that it has received approval from the US Food and Drug Administration (FDA) for its Varipulse pulsed field ablation system, which can be used to treat drug-resistant paroxysmal atrial fibrillation. After obtaining approval, Johnson&Johnson became the third company in the United States to have PFA technology for treating AFib, joining the ranks of Medtronic and Boston Scientific, and the PFA market’s top three competition officially opened. With the support of an ace, Johnson&Johnson has strong competitive strength It is understood that the Varipulse pulsed field ablation system consists of a Varipulse ablation catheter and a TRUPULSE generator. Among them, the VARIPULSE ablation catheter was developed based on Johnson&Johnson’s previous mapping catheter LASSO catheter, which is a continuation of LASSO catheter technology and further demonstrates Johnson&Johnson’s deep technical reserves in the catheter field. The Varipulse ablation catheter has 10 electrodes on the annular tip, and the size of ...
- Source: drugdu
- 53
- November 14, 2024
【EXPERT Q&A】What is the concept of GMP certification? What is the connection between GMP and FDA?

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 ...
- Source: drugdu
- 52
- November 13, 2024
6 innovative drugs expected to receive FDA approval in November

According to the expected target date of PDUFA, it is expected that in November, the US FDA will make regulatory decisions on the approval of six innovative drugs. This article will introduce these therapies. Active ingredient: Zenocutuzumab Indications: NRG1 positive non-small cell lung cancer (NSCLC) or pancreatic cancer Company Name: Merus Zenocutuzumab is a bispecific antibody targeting HER2 and HER3, which exhibits potential therapeutic efficacy against NRG1+cancer by uniquely binding to HER2 and effectively blocking the interaction between HER3 and NRG1 or NRG1 fusion protein. Preclinical studies have shown that zenocutuzumab can strongly inhibit the formation of HER2/HER3 heterodimers, thereby suppressing oncogenic signaling pathways, preventing tumor cell proliferation, and blocking tumor cell survival. Clinical studies have shown that it has anti-tumor activity in various types of NRG1+cancer. According to the mid-term data from the recently released Phase 1/2 clinical trial, zenocutuzumab has shown persistent efficacy in the treatment of advanced ...
- Source: drugdu
- 50
- November 7, 2024
Mesenchymal stromal cells (non stem cells) have been approved by the FDA for clinical trials in the treatment of acute ischemic stroke

The world’s first allogeneic adipose derived mesenchymal stromal cells (AD MSCs) drug (NR-20201) developed by Tianshi Pharmaceutical Group Co., Ltd. for the treatment of acute ischemic stroke received clinical trial approval from the US Food and Drug Administration (FDA) on October 26, 2024. It is reported that in the process of developing NR-20201, the company used artificial intelligence to analyze single-cell transcriptomics, cell life trajectories, and fate outcomes [1,2], confirming that the AD MSCs produced by Tasly’s standard preparation process are mesenchymal stromal cells rather than mesenchymal stem cells. Based on the difference between stromal cells and stem cells, this product has unique identification criteria and a mechanism of action different from stem cells. This product selects a suitable treatment time window based on the patient’s condition, promoting effective homing of cells after intravenous infusion. After cell homing, it works synergistically with endothelial cells to activate vascular regeneration and functional ...
- Source: drugdu
- 50
- November 2, 2024
Medtronic’s’ 2 Medical Devices’ Approved for Market by FDA

Recently, Medtronic announced that its Affera radiofrequency ablation system and Sphere-9 catheter have been approved for market by the US Food and Drug Administration (FDA). It is understood that this is an integrated electrophysiological product capable of pulsed field ablation (PFA) and radiofrequency (RF) ablation, approved for the treatment of persistent atrial fibrillation (AFib) and tricuspid isthmus dependent atrial flutter, and previously obtained CE marking approval in March 2023. Innovative products demonstrate differentiation advantages The two medical devices approved this time originated from Affera, which Medtronic acquired for $1 billion in August 2022 and introduced these technologies. The competition in the field of electrophysiology is fierce, and Medtronic has further solidified its position with these two medical devices. The Affera radiofrequency ablation system is an integrated high-resolution mapping and treatment solution that provides more predictable and flexible surgery, allowing doctors to accurately map and ablate using radiofrequency and electrical pulse ...
- Source: drugdu
- 69
- October 30, 2024
Boston Scientific’s’ 2 Medical Devices’ Approved for Market by FDA

On October 21st, according to foreign media Fierce Biotech, the FARAWAVE NAV ablation catheter and Faraview software integrated with Boston Scientific’s navigation function have been approved by the US Food and Drug Administration (FDA). It is reported that the above two products have been officially launched in the United States, forming part of the Boston Scientific Farapulse Pulsed Field Ablation (PFA) system, providing a new visualization solution for cardiac ablation surgery. New features added The FARAWAVE NAV ablation catheter is an upgrade based on the previous generation PFA product FARAPULSE. It looks very similar to the FARAPULSE ablation catheter in appearance, but the new generation product has many new features that were not present in the previous generation product – magnetic navigation function and equipped with a dedicated 3D FARAVIEW module (software). Therefore, this also enables the FARAWAVE NAV ablation catheter to have both ablation and mapping functions:  Ablation ...
- Source: drugdu
- 80
- October 24, 2024
Pfizer’s innovative drug HYMPAVZI ™ Mataximab hncq has been approved by the FDA for the treatment of hemophilia A and hemophilia B

The approval of HYMPAVZI is based on the results of a phase III trial study, which showed that compared with factor based prophylaxis and on-demand treatment, the drug can significantly reduce bleeding rates in eligible hemophilia A and hemophilia B patients without inhibitors. HYMPAVZI is the first weekly subcutaneous injection regimen provided in the United States for eligible hemophilia B patients. At the same time, it is also the first regular treatment provided to eligible hemophilia A and hemophilia B patients through pre filled injection pens or syringes. Recently, Pfizer’s innovative drug HYMPAVZI ™ Mataximab hncq has been approved by the US Food and Drug Administration (FDA) for the regular treatment of hemophilia A (congenital factor VIII deficiency) or hemophilia B (congenital factor IX deficiency) patients over 12 years old without coagulation factor inhibitors, in order to reduce bleeding episodes. HYMPAVZI is the first and only approved anti tissue factor ...
- Source: drugdu
- 64
- October 16, 2024
Victory! FDA approves Pfizer’s hemophilia A or B monoclonal antibody drug Marstacimab

Pfizer – after starting a showdown with a radical investor, being betrayed by two former executives, reuniting with two former executives, and ending work on an RSV drug – finally has some good news, straightforward. On Friday, the FDA approved Pfizer’s hemophilia A or B drug Marstacimab, which will be sold under the Hympavzi brand. This therapy is an anti tissue factor pathway inhibitor that helps hemophilia patients form blood clots to limit their bleeding episodes. A Pfizer spokesperson stated in an email to Endpoint News that the wholesale procurement cost for this weekly drug is $795600 per year, which is consistent with the WAC pricing for available prophylactic treatments for hemophilia A or B. It plans to start selling this drug this quarter. This drug is packaged as a pre filled automatic injection pen, which analysts say can help it find a place in the market. Given the maturity ...
- Source: drugdu
- 75
- October 15, 2024
FDA Approves Pfizer’s Hemophilia A or B Monoclonal Antibody Drug Marstacimab

On Friday, the FDA approved Pfizer’s hemophilia A or B drug Marstacimab, which will be sold under the Hympavzi brand. This therapy is an anti tissue factor pathway inhibitor that helps hemophilia patients form blood clots to limit their bleeding episodes. A Pfizer spokesperson stated in an email to Endpoint News that the wholesale procurement cost for this weekly drug is $795600 per year, which is consistent with the WAC pricing for available prophylactic treatments for hemophilia A or B. It plans to start selling this drug this quarter. This drug is packaged as a pre filled automatic injection pen, which analysts say can help it find a place in the market. Given the maturity of factor replacement and the moderate improvement of Mastacrolizumab compared to conventional prevention, Pfizer will have to rely to some extent on the argument of convenience to gain traction, “TD Cowen analyst wrote in a ...
- Source: drugdu
- 62
- October 15, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.