| |NOVEMBER 20248US FDA NODS SPECIAL DESIGNATION TO BOOST RARE PEDIATRIC DRUG DEVELOPMENTBayer revealed that it received approval from the U.S. Food and Drug Administration (FDA) for its MEDRAD® Centargo CT Injection System, a groundbreaking multi-patient injector that enhances workflow efficiency through design elements that align with Bayer's range of products, particularly in high-volume CT environments.Bayer's MEDRAD® Centargo CT Injection System provides benefits for radiology departments as the US encounters a shortage of radiology technologists alongside an increasing need for medical imaging."Since its launch in 2020, Centargo has served approximately seven million patients across 49 markets world-wide. The FDA clearance further demonstrates our nearly 40 years of CT innovation and commitment to delivering effective technologies to improve diagnostic imaging for patients," said Sven Schmidt, Head of Region Americas Radiology at Bayer. "We know radiologists today are facing a continuously increasing workload, and the automation, integration and mobility of the MEDRAD® Centargo CT Injection System helps radiology staff do more with less, allowing them more time to focus on their patients.""We've found the ease of using the Centargo injection system is having a real impact on our technologists' ability to do their work quickly and with less worry," says Mike Minoo, Manager, CT and Interventional Radiology at Sunnybrook. "For example, because I am spending less time preparing the injector and its components, I have more time to spend with the patient, increasing their comfort level and understanding of the procedure. The quality of this interaction provides a better overall experience for both myself as a clinician and the patient." POThe US FDA awards Rare Paediatric Disease Designation to encourage the development of drugs for serious conditions impacting fewer than 200,000 children in the US. Since these illnesses present distinct hurdles for drug development, it is essential to concentrate on offering treatment alternatives for these children. Firms that obtain authorization for a medication or biologic with this classification might qualify for a voucher, which can be used for expedited evaluation of another product. Moreover, this voucher can be transferred or sold to a different sponsor.Cumberland Pharmaceuticals Inc., a specialized pharmaceutical firm, revealed that the United States (US) Food and Drug Administration (FDA) has awarded Orphan Drug Designation and Rare Paediatric Disease Designation to Ifetroban for treating cardiomyopathy related to Duchenne muscular dystrophy (DMD). Cumberland is finalizing the FIGHT DMD trial, a multicenter, double-blind, placebo-controlled Phase II study examining the pharmacokinetics, safety, and effectiveness of daily oral Ifetroban in individuals with DMD. Outcomes will be revealed later this year."For Duchenne muscular dystrophy, a devastating genetic disorder affecting young boys, securing both Orphan Drug and Rare Paediatric Disease Designations for Ifetroban from the FDA is a critical step forward," said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals. "These designations not only recognize the urgent need for effective treatments but also provide vital support to accelerate research and development. These important regulatory milestones represent hope for families and a pathway to bring transformative medicines to a vulnerable patient population more quickly and efficiently." POTOP STORIESFDA APPROVES BAYER'S MEDRAD CENTARGO CT INJECTION SYSTEM
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