Rockville, MD – ExeGi Pharma LLC, a leader in digestive health solutions, is proud to announce that its flagship product, Visbiome GI Care Probiotic Capsules, has achieved the prestigious Clean Label Project® Certification and Clean Label Project Pesticide Free Certification. The Clean Label Project is a national nonprofit consumer advocacy and standards development organization focused on health and transparency in consumer product labeling. Through its rigorous testing and certification program, the Clean Label Project ensures that products meet the highest standards for ingredient purity and quality. “Our customers trust Visbiome to support their digestive health with the highest-quality probiotics subjected to extensive clinical testing,” said Marc Tewey, CEO of ExeGi Pharma. “Securing the Clean Label Project Certification is a testament to ...
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Rockville, M.D., and Charlotte, N.C., April 12, 2023 – ExeGi Pharma LLC (“ExeGi”), a leading developer of live biotherapeutic drugs and probiotics, has announced a partnership with TannerLAC, Inc. (“TannerLAC”), a division of Tanner Pharma Group, to distribute Visbiome in Mexico. Visbiome is a high potency probiotic medical food designed to manage microbial imbalances associated with medical conditions such as irritable bowel syndrome (IBS), Ulcerative Colitis (UC), Antibiotic-Associated Diarrhea (AAD), Pouchitis, and Hepatic Encephalopathy (HE). With a proven track record in over 80 human clinical trials performed over the past 20 years, Visbiome is the most extensively researched multi-strain probiotic available. TannerLAC provides pharmaceutical, biotech, and healthcare companies with a single-point partner for the commercialization of their products in challenging international markets. Under ...
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April 5, 2023 – ExeGi Pharma, LLC, owner of the Visbiome probiotic, has secured a significant legal victory against Brookfield Pharmaceuticals, LLC. ExeGi alleged that Brookfield engaged in false advertising and unfair competition by promoting its High Potency Probiotic (“HPP”) as a generic equivalent of Visbiome. The United States District Court for the Eastern District of Wisconsin ruled in favor of ExeGi, entering summary judgment and finding Brookfield liable for false advertising under the Lanham Act. The court also issued a permanent injunction against Brookfield to prevent the company from making any such false claims in the future. The court found that the Brookfield HPP product has a different composition than that of Visbiome, and Brookfield attempted to pass off HPP as a Visbiome generic equivalent. In a 44-page opinion, Judge J.P. Stadtmueller ...
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Rockville, MD – January 26th, 2023 ExeGi Pharma LLC, a leader in the development of live biotherapeutic drugs and probiotics, announced today that the FDA has cleared its Investigational New Drug (IND) application for its biologic drug candidate, EXE-346. This clearance allows the company to initiate a clinical trial for patients with an ileal pouch-anal anastomosis (IPAA or “J-Pouch”) who experience excessive stool frequency. “Excessive stool frequency is a significant challenge for many patients with a J-Pouch, and we are pleased to have the opportunity to investigate the potential benefits of EXE-346,” commented Dr. Hans Herfarth, MD, Ph.D., of the University of North Carolina Inflammatory Bowel Disease Center. And “We believe that the live biotherapeutic approach has the potential to ...
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