Latest news with #medicalproducts
Yahoo
09-07-2025
- Business
- Yahoo
Johnson & Johnson (JNJ) Applied to the European Medicines Agency to Expand AKEEGA Usage
Johnson & Johnson (NYSE:JNJ) is one of the . On July 3, Janssen-Cilag, a company of Johnson & Johnson (NYSE:JNJ), reported applying to the European Medicines Agency to expand the use of AKEEGA, a drug that combines niraparib and abiraterone acetate. The new application seeks approval for treating adults with metastatic hormone-sensitive prostate cancer who have specific genetic changes called homologous recombination repair gene alterations. While treatments for mHSPC have improved, over 20% of mHSPC patients have HRR gene alterations, including the BRCA1/2 genes. These patients often have worse outcomes and limited treatment options. A smiling baby with an array of baby care products in the foreground. Janssen-Cilag's submission is based on results from the Phase 3 AMPLITUDE study. This study tested niraparib and abiraterone acetate with prednisone or prednisolone versus the current standard treatment. The combination significantly delayed cancer progression and the worsening of symptoms. Johnson & Johnson (NYSE:JNJ) is an international healthcare company that develops and sells medical products. The company operates through two main segments, which include Innovative Medicine and MedTech. While we acknowledge the potential of JNJ as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
08-07-2025
- Business
- Yahoo
Rockwell Medical and Innovative Renal Care Announce Three-Year Partnership Agreement to Ensure Supply Chain Continuity of Quality Hemodialysis Products
WIXOM, Mich. & FRANKLIN, Tenn., July 08, 2025--(BUSINESS WIRE)--Rockwell Medical, Inc. (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, and Innovative Renal Care (IRC), one of the largest dialysis service providers in the United States, today announced they signed a multi-year service agreement to support IRC's goals to invest in high-quality hemodialysis products, streamline workflows, and help avoid potential supply chain disruptions. Under the terms of the agreement, Rockwell Medical will supply IRC with liquid and dry, acid and bicarbonate hemodialysis concentrates, as well as the DAMX45 dry acid concentrate mix system, which is 510(k) approved to be used exclusively with Rockwell Medical's CitraPure® and Dri-Sate® dry acid concentrate powders. This will enable IRC's dialysis centers across the United States to reduce storage requirements while ensuring product quality and continuity. This multi-million dollar purchase agreement with utilization commitments will remain in effect for three years with the option to extend an additional one-year period. "We are excited to partner with Rockwell Medical to reliably supply our clinics with hemodialysis concentrates," said David Doerr, Chief Executive Officer at IRC. "More efficient processes and supply chain continuity enables us to stay focused on achieving our company's mission to deliver more tomorrows to our patients, their families, and friends." "IRC is a comprehensive renal care company paving the way for innovative solutions to treat and manage patients with, or at high-risk of, end-stage renal disease," said Tim Chole, Senior Vice President and Chief Commercial Officer at Rockwell Medical. "We are excited to expand our supply agreement with IRC and build upon our long-standing reputation for a reliable supply chain, high-quality products, and excellent customer service." About Innovative Renal Care Innovative Renal Care (IRC) is a national leader in kidney care, partnering with nephrologists and health systems to provide exceptional care for patients with chronic kidney disease and end-stage renal disease. Through joint ventures and an innovative, collaborative model, IRC empowers local care teams with the tools, technology, and support to deliver industry-leading clinical outcomes and elevate the patient experience. Guided by our commitment to Delivering More Tomorrows, IRC stands apart as a trusted partner in advancing kidney care—one patient, one partnership, and one outcome at a time. To learn more, visit About Rockwell Medical Rockwell Medical, Inc. (Nasdaq: RMTI) is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products for dialysis providers worldwide. Rockwell Medical's mission is to provide dialysis clinics and the patients they serve with the highest quality products supported by the best customer service in the industry. Rockwell is focused on innovative, long-term growth strategies that enhance its products, its processes, and its people, enabling the Company to deliver exceptional value to the healthcare system and provide a positive impact on the lives of hemodialysis patients. Hemodialysis is the most common form of end-stage kidney disease treatment and is typically performed in freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities, or a patient's home. Rockwell Medical's products are vital to vulnerable patients with end-stage kidney disease, and the Company is relentless in providing unmatched reliability and customer service. Certified as a Great Place to Work® in 2023, 2024 and 2025, and named Fortune Best Workplaces in Manufacturing & Production™ in 2024, Rockwell Medical is Driven to Deliver Life-Sustaining Dialysis Solutions™. For more information, visit Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as, "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "can," "would," "develop," "plan," "potential," "predict," "forecast," "project," "intend," "look forward to," "remain confident," "are determined," "are on track," "are resolute in our vision," "work to," "drive towards," "focused on," or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical's SEC filings), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include, but are not limited to those risks more fully discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2024, as such description may be amended or updated in any future reports we file with the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law. View source version on Contacts Rockwell Medical, Inc. Heather R. HunterSVP, Chief Corporate Affairs Officer(248) 432-1362IR@ Innovative Renal Care Amanda ReedVP, Marketing & Communications(321) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Wall Street Journal
07-07-2025
- Business
- Wall Street Journal
Baxter International Names ATS' Hider as Next Chief Executive Officer
Baxter International BAX -0.95%decrease; red down pointing triangle has appointed Andrew Hider as president, chief executive officer and a board member. The medical products maker said Hider will assume his responsibilities no later than Sept. 3 or an earlier date pending completion of his current employment commitments. Hider has served as CEO of Canadian automation and technology company ATS since 2017.
Zawya
04-07-2025
- Health
- Zawya
Saudi: SFDA to penalize 996 erring establishments
RIYADH — Inspection teams from the Saudi Food and Drug Authority (SFDA) have detected violations of 996 establishments during inspection teams carried out during the last two months of April and May. The authority officials conducted 5,912 monitoring and investigation tours, resulting in the seizure of 996 violating establishments out of 4,307 establishments that covered inspections in various regions across the Kingdom. The inspection tours also resulted in the closure of 136 establishments for not obtaining the necessary licenses and for violations affecting product safety. In addition, 127 production lines were suspended and 1,750 types of products were seized and impounded. This comes as part of the authority's efforts to verify the compliance of establishments subject to its supervision with approved regulations and to achieve the highest levels of quality for products circulating in the markets. During these tours, the authority's inspection teams were able to seize violations of a food establishment where raw materials of unknown origin were found. It was also found that a number of workers were employed without health certificates that necessitated the closure of the facility by the authority and the adoption of necessary punitive measures. Several unlicensed warehouses were seized for illegally storing expired medical products, in conditions that violated transportation and storage requirements for medical products. A total of 313,789 products were immediately seized, and regulatory measures were completed against the violators to ensure consumer protection from unsafe products. The authority officials also seized a food factory that had committed several violations, including failure to obtain a Hazard Analysis Critical Control Points (HACCP) quality certificate, the accumulation of meat in raw material freezers, and signs of spoilage on some aged meat. In addition, the external production date did not match the production date on the product, and there was a noticeable decline in hygiene within the facility. Furthermore, some workers did not have health certificates. The inspection teams seized 2,000 kilograms of food products unfit for consumption. The authority is completing regulatory measures against the factory. During joint inspection tours, carried out along with the Saudi Authority for Industrial Cities and Technology Zones (MODON), the SFDA teams detected a number of violations on the part of a factory under construction. The most notable violations included the lack of a license from the SFDA, a complete lack of food safety regulations, manufacturing practices and production lines that violate food production requirements, and several violations affecting safety and quality. This prompted the closure of the factory and production lines, the precautionary recall of products pending analysis results to ensure their safety, and the adoption of legal action against the erring factory. The authority emphasized the need for facilities subject to its supervision to adhere to approved regulations and systems. It called for reporting any violations through contacting the unified number 19999. © Copyright 2022 The Saudi Gazette. All Rights Reserved. Provided by SyndiGate Media Inc. (
CBC
31-05-2025
- General
- CBC
Diabetes Canada warns about products with fake endorsement
Diabetes Canada says it has received hundreds of phone calls about social media ads for medical products claiming to be endorsed by the organization, something it says it never does.
