FDA PDUFA Date Set for C diff Drug, SER-109
The US FDA has accepted a Biologics License Application (BLA) for Seres Therapeutics' SER-109, and set a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2023.
C Diff Drug Development
BiomeBank Continues Growth Trajectory With Over $10M Capital Raise - Business Wire
Oral Microbiome Therapeutic Gets Priority Review for Recurrent C difficile Infection
SER-109 contains purified bacterial spores of multiple Firmicute species obtained from the stool of healthy human donors.
Clostridium Difficile Infections Pipeline Drugs and Companies Insight Report (2022): Analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments
With a Massive CAGR of 25%, Human Microbiome Market Size to surpass US$ 442.37 billion by 2030
Pune, Dec. 09, 2022 (GLOBE NEWSWIRE) -- According to a new market research report titled, “Human Microbiome Market by Product (Probiotics, Prebiotics,...
Nicholas Meyer on Twitter
“#cdiff folks, if you are diagnosed with c-diff then look into enrolling in acurx phase 2 trial. 100% cure rate in phase 2a and showed a microbiome response that has never been seen before in history of c-diff antibiotics”
New Therapeutic Offers Promise for Recurrent C Diff Infection
An easy-to-administer oral biologic kept repeat C difficile infections at bay in a new study.
FDA Approves First Fecal Microbiota Product | FDA
The FDA approved the first fecal microbiota product, Rebyota, for the prevention of recurrence of CDI in adults.
MTIG on Twitter
#MicrobiomeTherapeutics have potential to restore microbial diversity to prevent #CDiff spore germination & disease without the complications of antibiotics. Learn about @Rebiotix, @SeresTX & @VedantaBio's work to develop microbiome therapeutics for CDI: https://t.co/dXa0aXsMUb— MTIG (@MTIG_News) December 6, 2022
FDA Approval of First Fecal Microbiota Product Ensures Safety in Standardization: Ferring Chief Scientific Officer Dr. Elizabeth Garner explains the FDA approval of recurrent C diff treatment RBX2660 provides more than a treatment… https://t.co/yzGZzeZa
FDA Approval of First Fecal Microbiota Product Ensures Safety in Standardization: Ferring Chief Scientific Officer Dr. Elizabeth Garner explains the FDA approval of recurrent C diff treatment RBX2660 provides more than a treatment… https://t.co/yzGZzeZaWR #cdiff #cdi #fmt— Dave Roberts (@CDifficile1) December 8, 2022
FDA Greenlights First Fecal Microbiota Product | MedPage Today
Rebyota approved for preventing recurrence of C. difficile infection
Expanding Government Assistance is Controlling the Market, Microbiome Therapeutics Market to Grow By 32% CAGR through 2032, Says Fact.MR - GlobeNewswire
Improved Microbiome Sequencing Capabilities are Likely to Boost the Microbiome Therapeutics Market...
Looking Beyond C difficile: The Potential of the Gut Microbiome - Contagionlive.com
Dr. Elizabeth Garner speculates the FDA approval of RBX2660 for recurrent C difficile infection will pave the way for more restorative microbiome therapies.
Seeking therapeutic opportunities amid the complexity of the microbiome
Companies developing microbiome-based therapies have been beset by challenges in the past few years, but hopes remain for some applications and could soon be boosted by the first regulatory approval in the field.
US FDA approves Ferring's Rebyota for Clostridioides difficile infection - Pharmaceutical Technology
The US FDA has granted approval for Ferring Pharmaceuticals’ Rebyota to prevent Clostridioides difficile infection recurrence.
Using Immunoinformatics to Create a Clostridium Difficile Vaccine - Pharmacy Times
Immunoinformatics allows researchers to develop vaccines without microbial culturing, thus saving time and money.
SER-109, CP101, VE303 for Treatment of Recurrent C. difficile Infection (rCDI) - Pharmacy Times
Drs Abraham and Feuerstadt share recent data with emerging live biotherapeutic products, SER-109, CP101, and VE303, for treatment of recurrent C difficile infection (rCDI).
Global Microbiome Therapeutics Market Report 2022: Mergers and Collaborations Continue to Boost Brand New Industry - ResearchAndMarkets.com - Business Wire
Clostridium Difficile Diagnostics Market to Surpass US$ 1,450.29 Mn with a CAGR of 7.1% by 2030 | Abbott Laboratories - Medgadget
Clostridium Difficile Infections Pipeline: Insights into Novel Pipeline Therapies, Key Pharma Companies, Growth Prospects and Future Clostridium Difficile Infections Pipeline Landscape - Digital Journal
DelveInsight’s, “Clostridium Difficile Infections (Clostridium Difficile Associated Disease) Pipeline Insight, 2022” report provides comprehensive insights about 25+ companies and 25+ pipeline drugs in Clostridium Difficile Infections (Clostridium Difficile Associated Disease) pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route […]
Insights into the Spectrum of Activity and Mechanism of Action of MGB-BP-3
MGB-BP-3 is a potential first-in-class antibiotic, a Strathclyde Minor Groove Binder (S-MGB), that has successfully completed Phase IIa clinical trials for the treatment of Clostridioides difficile associated disease. Its precise mechanism of action and the origin of limited activity against …
Clostridium Difficile Infection Market to Witness Upsurge in Growth During the Forecast Period (2022-2032), Examines DelveInsight | Key Companies – Summit Therapeutics, Merck Sharp & Dohme LLC, Astellas Pharma Inc., Acurx Pharmaceuticals Inc., a - Digit
(Nevada, USA) DelveInsight’s “Clostridium Difficile Infection Market Insight, Epidemiology and Market Forecast – 2032” report provides current treatment practices, emerging drugs, Clostridium Difficile Infection market share of the individual therapies, current and forecasted Clostridium Difficile Infection market size from 2019 to 2032 segmented by seven major markets. The report also offers current Clostridium Difficile […]
Redefining genomic view of Clostridioides difficile through pangenome analysis and identification of drug targets from its core genome - PubMed
The suggested potent targets could act as broad-spectrum drug targets for C. difficile. However, further validation needs to be done before using them for lead compound discovery.
GutMicrobiota Health on Twitter
In terms of prophylaxis against C. difficile infection, @bhmullish says some adsorbent agents and vaccines will be worth considering in the future@esnm_eu #GMFHCoverage pic.twitter.com/pZ3e0oQEoz— GutMicrobiota Health (@GMFHx) November 22, 2022
GutMicrobiota Health on Twitter
First-line faecal microbiota transplantation is highly effective and superior to the standard of care vancomycin alone in achieving sustained resolution from C. difficile, according to a recent study in @LancetGastroHep now presented by @bhmullish @esnm_eu #GMFHCoverage pic.twitter.com/Ivol77W1XS— GutMicrobiota Health (@GMFHx) November 22, 2022
GutMicrobiota Health on Twitter
The loss of gut microbiota-derived bile salt hydrolases predisposes to CDI. @bhmullish & colleagues showed restoration of gut BSH functionality contributes to the efficacy of FMT in treating rCDI based on a paper in @Gut_BMJ @esnm_eu #GMFHCoverage pic.twitter.com/0jeZAkk7Ax— GutMicrobiota Health (@GMFHx) November 22, 2022
GutMicrobiota Health on Twitter
Blount: As microbiome is considered a new organ in the scientific and medical arena, there is an ongoing debate on whether fecal microbiota transplant is a drug or an organ@esnm_eu #GMFHCoverage pic.twitter.com/x9UM5e9PdE— GutMicrobiota Health (@GMFHx) November 22, 2022
GutMicrobiota Health on Twitter
The design of clinical trials is relevant for ensuring reproducibility of microbiota-based therapeutics. Blount now shares the pipeline of RBX2660 for reducing recurrent C. difficile infection @Rebiotix @FerringMBiome @esnm_eu #GMFHCoverage pic.twitter.com/4QlKcJrYy6— GutMicrobiota Health (@GMFHx) November 22, 2022
Blount: A recent phase 3 clinical trial on RBX2660 shows treatment success with more than 90% of responders maintaining treatment success through 6 months of follow-up @esnm_eu #GMFHCoverage
According to Blount, microbiome changes are relevant in explaining the efficacy of RBX2660. High engraftment persisted to at least 6 months after study treatment @esnm_eu #GMFHCoverage
According to Blount, microbiome changes are relevant in explaining the efficacy of RBX2660. High engraftment persisted to at least 6 months after study treatment @esnm_eu #GMFHCoverage pic.twitter.com/rX4sRcbZLe— GutMicrobiota Health (@GMFHx) November 22, 2022