Abstract Microbiome drug development has captured significant interest over the last decade. However, despite the recent clinical and regulatory success stories, this area is lately regarded as a high-risk one by investors given the current […]
Historically, researchers have surveyed the composition and/or expression of microorganisms within the human gut microbiome by collecting fecal samples, isolating microbial nucleic acids, and using those nucleic acids to analyze the microbial species present within […]
Seres Therapeutics, Inc. (Nasdaq: MCRB) and Nestlé Health Science today announced the U.S. Food and Drug Administration (FDA) approval of VOWSTTM (fecal microbiota spores, live-brpk), formerly called SER-109, an orally administered microbiota-based therapeutic to prevent recurrence of C. difficile Infection (CDI) in adults […]
Vedanta Biosciences, a clinical-stage company that is developing a potential new category of oral therapies based on defined bacterial consortia, today announced that it has raised $106.5 million to support pivotal-stage development of its lead […]
In a step forward for genetic engineering and synthetic biology, researchers have modified a strain of Escherichia coli bacteria to be immune to natural viral infections while also minimizing the potential for the bacteria or their modified […]
In a letter to the National Union of Food Supplements, the Direction générale de la consommation, de la concurrence et de la répression des fraudes (DGCCRF) outlined that supplements can use the term so long […]
Leveraging a year of important research updates, funding rounds, and academic papers, this report compiles the most significant industry news pertaining to microbiome drug development in 2022. It finds that the regulatory approval of three […]
Today, the U.S. Food and Drug Administration approved Rebyota, the first fecal microbiota product approved by the agency. Rebyota is approved for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years […]
Proge Farm, an Italian pharmaceutical company, has made microbiome history with its recently approved therapeutic and will now be able to market its drug based on Lactobaccilus plantarum P 17630. The company obtained authorization from […]
Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for investigational oral microbiome therapeutic SER-109 for […]