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 ...
Not long ago, Larry Jones, Global Vice President and Group Chief Information Officer of Johnson & Johnson MedTech, announced his decision to resign. On the LinkedIn platform, Jones recalled fondly: “Looking back on the 35 glorious years spent at Johnson & Johnson, my heart is filled with deep nostalgia for the extraordinary times we have gone through together.” During his tenure in Johnson & Johnson’s medical device department, Jones was particularly committed to promoting the company’s innovation in oncology, orthopedics, cardiovascular and general surgery, and realizing the innovation of digital surgical connection solutions through advanced technologies such as surgical robots and machine learning platforms. As a senior technology executive, Jones has rich leadership experience. During his decades in office, he has led many major projects in Johnson & Johnson’s pharmaceutical and medical device departments, including the recent three-year, $200 million global digital transformation plan. According to LinkedIn information, Jones is ...
On October 12, according to the official website of CDE, Johnson & Johnson’s Class 1 new drug JNJ-78278343 injection obtained implicit approval for clinical trials and is suitable for the treatment of adult male patients with advanced prostate cancer. According to public information, JNJ-78278343 is a KLK2-CD3 bispecific antibody and T cell redirection product, which is designed to target KLK2 and induce T cell activation by binding to CD3 on T cells. This product has potential immunomodulatory and anti-tumor activity. After administration, it can bind to CD3 on T cells and KLK2 on tumor cells expressing KLK2, thereby redirecting T cells to tumor cells expressing KLK2, resulting in T cell-mediated lysis of KLK2-expressing tumor cells. At present, Johnson & Johnson has conducted a number of studies on JNJ-78278343 for prostate cancer internationally. Among them, the Phase 1 study of JNJ-78278343 monotherapy for advanced prostate cancer is expected to be initially ...
On September 25, according to foreign media Endpoints, Johnson & Johnson is closing the cardiovascular and metabolic drug unit of its pharmaceutical division. This is the second large-scale reorganization since Johnson & Johnson closed its infectious disease and vaccine units. Johnson & Johnson has gradually downplayed cardiopulmonary and metabolic work since last year. Under the change, Johnson & Johnson has narrowed its research and development focus to three therapeutic areas: oncology, immunology and neuroscience. This reorganization mainly affects the commercialization work of the cardiovascular department (sales, marketing and medical affairs teams), not research and development. At present, the cardiovascular department of Johnson & Johnson’s medical device department has not been affected, and its acquisitions are still ongoing. The core product of Johnson & Johnson’s cardiovascular and metabolic drug department is Xarelto (rivaroxaban), which was once one of the world’s best-selling anticoagulants and was jointly developed by Johnson & Johnson and ...
Johnson & Johnson has had frequent executive changes in recent years, not only in the innovative pharmaceutical industry, but also in the medical technology department. At least nine executive changes have been reported since 2023. Recently, Enovis, a global orthopedic giant, announced the appointment of Tim Czartoski as president of its U.S. surgical and global products and supporting technologies business. Tim Czartoski previously worked in the DePuy Synthes orthopedic business unit of Johnson & Johnson Medical Technology. Tim Czartoski is a very experienced veteran in the medical field. He has more than 20 years of experience in the medical technology industry, especially in the orthopedic business. Tim Czartoski has held several key positions at Johnson & Johnson, leading the growth of Johnson & Johnson’s business. Looking back at Tim Czartoski’s career at Johnson & Johnson, he has held several positions in the DePuy Synthes orthopedic business unit of Johnson & ...
On September 11, 2024, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients. The company claims that Tremfya is the first and only dual-action inhibitor targeting interleukin 23 (IL-23) approved for the treatment of active ulcerative colitis, further solidifying Johnson & Johnson’s leadership in the field of inflammatory bowel disease. Guselkumab is the first approved interleukin 23 (IL-23) inhibitor in the world, selectively binding to the p19 subunit of IL-23 to inhibit its interaction with the IL-23 receptor. It has shown strong efficacy for various autoimmune diseases; it can block IL-23 while also binding to the CD64 receptors on cells that produce IL-23. It is currently approved for the treatment of plaque psoriasis, active psoriatic arthritis, and UC. Furthermore, in June 2024, Johnson & Johnson submitted a supplemental Biologics ...
By Don Tracy, Associate Editor The acquisition, valued at $600 million, is expected to integrate V-Wave into Johnson & Johnson MedTech, which could improve the treatment of heart failure with reduced ejection fraction.Johnson & Johnson (J&J) has reached a definitive agreement to acquire V-Wave Ltd., a private company specializing in cardiovascular implants for heart failure patients. The acquisition is expected to integrate V-Wave into Johnson & Johnson MedTech. V-Wave was recently granted FDA Breakthrough Device Designation and CE mark approval for the Ventura Interatrial Shunt technology, which treats heart failure with reduced ejection fraction (HFrEF). The deal is expected to close by the end of this year.1 “We are excited to welcome V-Wave to Johnson & Johnson MedTech and to take another meaningful step toward transforming the standard of care for cardiovascular disease. We recognize the importance of identifying more diverse and effective treatments for heart failure, and our recent ...
By Don Tracy, Associate Editor Approval of Spravato would mark the first monotherapy to be available on the market for treatment-resistant depression in the United States.Johnson & Johnson (J&J) has submitted a supplemental New Drug Application (sNDA) to the FDA for the approval of Spravato (esketamine) as the first and only monotherapy for the treatment of treatment-resistant depression (TRD). According to the company, the sDNA is supported by encouraging data from the Phase IV TRD4005 trial, which evaluated the efficacy, safety, and tolerability of Spravato as a monotherapy. “Many patients living with challenging-to-treat depression spend far too long cycling through multiple treatments that don’t effectively resolve their symptoms, which can cause a significant functional and emotional burden on patients and their loved ones,” said Bill Martin, PhD, global therapeutic area head, neuroscience, Johnson & Johnson Innovative Medicine, in a press release. “We’re pleased to build on the more than a ...
By Don Tracy, Associate Editor Results from the Phase III STREAM Stage 2 study show the efficacy and safety of an all-oral bedaquiline-containing regimen for multidrug-resistant pulmonary tuberculosis. The FDA has granted a full approval to Johnson & Johnson’s (J&J) Sirturo for use in combination therapy in treating pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis resistant to rifampicin and isoniazid. According to the company, the approval by the FDA effectively removes previous label restrictions that were part of the medicine’s accelerated approval in December 2012. The regulatory action was based on promising results from the Phase III STREAM Stage 2 study.1 STREAM Stage 2 was the first large-scale, randomized, multi-country open-label clinical study to evaluate the efficacy and safety of an all-oral bedaquiline-containing regimen for treatment of MDR-TB. Between March 28, 2016, and January 28, 2020, 1436 participants were screened with 588 individuals randomly assigned to either the 2011 WHO ...
Don Tracy, Associate Editor The acquisition of a novel therapy for atopic dermatitis includes an all-cash transaction totaling approximately $1.25 billion. Image Credit: Adobe Stock Images/Ityuan Johnson & Johnson (J&J) announced that it has agreed to terms with Numab Therapeutics to acquire its wholly owned subsidiary for the global rights to NM26, an investigational bispecific antibody currently in Phase II of development for the treatment of atopic dermatitis (AD). Under terms of the deal, J&J will pay Numab around $1.25 billion in an all-cash transaction. According to the company, the transaction is expected to close later this year, clearance under the Hart-Scott-Rodino Antitrust Improvements Act and fulfillment of customary closing conditions. NM26 targets two established pathways, interleukin (IL)-4Rα and IL-31, in AD. According to investigators, this works by targeting IL-4Rα, which is responsible for Th2-mediated skin inflammation, and IL-31, which triggers skin itch and exacerbates AD. Additionally, NM26 has demonstrated ...
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