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Editor’s Choice
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 […]
Editor's Choice
Ferring Receives Positive Vote from U.S. FDA Advisory Committee for RBX2660
Ferring Pharmaceuticals today announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) issued a positive vote for RBX2660, an investigational microbiota-based live biotherapeutic studied for its potential […]
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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 […]
Pharma & Human Health
CosmosID-Hub: An Interactive Metagenomics Analysis Platform with Increased Accuracy and Precision at the Strain-level
The advent of metagenomic sequencing has led to significant advancements in our understanding of the microbiome in a wide variety of contexts, from the human body1 to farm animals2,3, soil, and marine environments4. Each unique […]
Pharma & Human Health
First-ever mycobiome atlas describes associations between cancers and fungi
An international team of scientists, co-led by researchers at the University of California San Diego School of Medicine, has created the first pan-cancer mycobiome atlas — a survey of 35 types of cancer and their […]
