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Editor’s Choice
Editor's Choice
FDA Approves First Fecal Microbiota Product
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 […]
Editor's Choice
Seres Therapeutics Announces FDA acceptance of Biologics License Application For Ser-109
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 […]
Editor's Choice
A microbiome therapeutic is closer than ever to market authorization in the US. What does it mean for the industry?
Ferring Pharmaceuticals, Inc. has edged ahead in the race to bring the first microbiome-based drug to market in the United States, with its product REBYOTA receiving the thumbs up from the FDA’s Vaccines and Related […]
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Finance
SYNLAB and Microba expand strategic agreement on advanced gut microbiome test
SYNLAB, the leader in medical diagnostic services and specialty testing in Europe, and Microba Life Sciences (Microba), a global leader in the analysis of complex gut microbiomes, have expanded their strategic agreement to broaden geographic […]
Finance
Maximizing on the Skin Microbiome Movement
By 2028 the global skin care market is projected to near $145.82 billion1, #skincareproducts2 has two billion plus views and counting on TikTok, and Vogue’s 2022 skin care trends3 include “supporting the skin’s microbiome.” The fascination with skin […]
Pharma & Human Health
Lonza Launches New Capsule to Deliver Acid-Sensitive Active Pharmaceutical Ingredients to the Intestine
Lonza, a preferred partner to the pharmaceutical, biotech and nutraceutical markets, has launched an innovative new capsule solution for intestinal (enteric) drug delivery. The Capsugel® Enprotect™ capsule does not disintegrate during stomach transit and only […]
Editor's Choice
Seres Therapeutics Announces FDA acceptance of Biologics License Application For Ser-109
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 […]
Finance
The Complexities of Regulatory Approval for Live Biotherapeutic Products Unravelled
Regulatory requirements are not yet clearly defined due to the relative novelty of LBPs. In addition, there is an inherent lack of straightforward biomarkers in microbiome research, which can make it problematic to link LBPs […]
Pharma & Human Health
Anti-anaerobic antibiotics associated with increased risk of mortality in critically ill patients
A common clinical practice may be inadvertently harming patients, according to new research published October 13 in the European Respiratory Journal. Theteam of Michigan Medicine researchers behind the study suggest that administration of antibiotics with […]
Pharma & Human Health
NIH-supported clinical trial of phage therapy for cystic fibrosis begins
Enrollment has begun in an early-stage clinical trial evaluating bacteriophage therapy in adults with cystic fibrosis (CF) who carry Pseudomonas aeruginosa (P. aeruginosa) in their lungs. The trial is evaluating whether the bacteriophage, or “phage,” […]
Pharma & Human Health
Researchers find tumor microbiome interactions may identify new approaches for pancreatic cancer treatment
Investigators from Rutgers Cancer Institute of New Jersey, the state’s leading cancer centerand only National Cancer Institute-Designated Comprehensive Cancer Center, together with RWJBarnabas Health, examined the microbiome of pancreatic tumors and identified particular microorganisms at […]
