Pharmafile

APRIL 25, 2023

Published date: 25/04/2023 Summary: Financing will enable pivotal Phase 3 study of VE303 for recurrent C. million to support pivotal-stage development of its lead candidate, VE303, for the prevention of recurrent Clostridioides difficile infection (CDI), and a read more

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Pharmacy Joe

OCTOBER 9, 2022

In this episode, I’ll discuss an article about fecal microbiota transplantation for the first or second Clostridioides difficile infection. The primary endpoint was the resolution of C difficile-associated diarrhea 8 weeks after treatment. The absolute risk reduction in favor of Early FMT was 57%.

Hospitals 52

Hospitals Inpatient 52

Pharmaceutical Technology

MAY 18, 2023

Biotechnology company Lumen Bioscience has secured fast track designation from the US Food and Drug Administration (FDA) for LMN-201 for the treatment and prevention of C difficile infection (CDI). It is compatible with standard-of-care antibiotics.

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Pharmacy Joe

OCTOBER 9, 2022

In this episode, I’ll discuss an article about fecal microbiota transplantation for the first or second Clostridioides difficile infection. The primary endpoint was the resolution of C difficile-associated diarrhea 8 weeks after treatment. The absolute risk reduction in favor of Early FMT was 57%.

Hospitals 40

Hospitals Inpatient 40

Pharmaceutical Technology

OCTOBER 27, 2022

The US Food and Drug Administration (FDA) has accepted Seres Therapeutics’ Biologics License Application (BLA) for SER-109 to prevent recurrent C. difficile infection (rCDI) for priority review. According to the trial data, 88% of participants in the SER-109 arm were free from C.

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Pharmaceutical Technology

APRIL 26, 2023

Vedanta Biosciences intends to use the funds to advance a pivotal Phase III trial of its lead candidate, VE303, to prevent recurrent clostridioides difficile infection (CDI). It comprises eight types of clonal human commensal bacteria strains chosen to offer colonisation resistance to C difficile.

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European Pharmaceutical Review

DECEMBER 1, 2022

Rebyota, the first faecal microbiota product to prevent recurrence of Clostridioides difficile infection (CDI) in people 18 years and older after being given antibiotics for recurrent CDI, has been approved by the US Food and Drug Administration (FDA). Further clinical study data for Rebyota. The effectiveness of Rebyota for C.

Labelling 86

Labelling 86

Pharmacy Times

OCTOBER 5, 2022

Drs Feuerstadt, Abraham, and Chopra discuss clinical trial data for RBX2660, a live biotherapeutic product, in treatment of recurrent C difficile infection (rCDI), as well as data with RBX2660 that were presented at DDW 2022.

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European Pharmaceutical Review

OCTOBER 11, 2023

As part of newly acquired assets from live biotherapeutics products (LBP) manufacturer Federation Bio, Kanvas Biosciences now has two active microbiome-based clinical programmes. This acquisition allows us to manufacture and clinically investigate complex microbial consortia much faster than previously envisioned.

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Immunity Immunization 78

pharmaphorum

OCTOBER 27, 2022

The FDA has accepted for review Seres Therapeutics’ Biologics License Application (BLA) for SER-109, an investigational oral microbiome therapeutic for the prevention of recurrent Clostridium difficile infection (rCDI). The study showed that at eight weeks post-treatment 88% of subjects in the SER-109 group were free from C.

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Labelling Hospitals 45

PharmaShots

MAY 8, 2023

of patients achieved clinical response @8wks. achieved a clinical response @8wk.; The results were published in JAMA Network Open Ref: Businesswire | Image: Seres Therapeutics Related News:- Seres Therapeutics and Nestlé Health Science Receive the US FDA’s Approval of VOWST for the Prevention of Recurrence of C.

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Labelling 40

European Pharmaceutical Review

JUNE 27, 2023

Riding on the momentum of the first faecal microbiota product approved for C. difficile in December 2022, the microbiome therapies space in 2023 has continued to see revolutionary developments and continued research advancement. What are the most promising microbiome therapeutics in clinical development?

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Immunity Immunization Chemotherapy Vaccines 99

Amber

JULY 13, 2023

Amber Specialty Pharmacy will begin dispensing VOWST, which is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI). Difficile Infection in Adults appeared first on Amber Specialty Pharmacy.

Specialty Pharmacies 52

Specialty Pharmacies 52

pharmaphorum

JULY 2, 2021

Swiss food giant Nestle has firmed up its five-year-old alliance with US microbiome specialist Seres, paying $175 million upfront for North American co-marketing rights to its lead drug for Clostridium difficile infections. Nestle and Seres have been working together on the microbiome project since 2016, focusing on C. diff infection.

Hospitals 69

Hospitals 69

pharmaphorum

SEPTEMBER 30, 2020

million to develop VE303 for high-risk Clostridioides difficile (C. Products such as this aim to repopulate the gut with harmless bacteria that are resistant against pathogenic bacteria such as C. The study is enrolling patients with a recent confirmed diagnosis of C. infection by a US government agency. Diff infection.

Immunity 52

Immunity Immunization 52

PharmaShots

FEBRUARY 17, 2023

Difficile Infection Date: Feb 15, 2023 | Tags: Seres Therapeutics, SER-109, Recurrent C. to go Public via Austin Biosciences SPAC Merger for ~$166.3M to go Public via Austin Biosciences SPAC Merger for ~$166.3M

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Biosimilars Vaccines 40

pharmaphorum

MARCH 2, 2022

Pfizer’s vaccine for Clostridium difficile (C. The pharma company was quick to point out however that the CLOVER trial of PF-06425090 was undermined by a lower-than expected rate of C. With no approved vaccines to date, C. As it stands, PF-06425090 is still leading the field among candidate vaccines for C.

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Vaccines Hospitals 52

PharmaShots

APRIL 28, 2023

Difficile Infection Date: Apr 27, 2023 | Tags: Seres Therapeutics, Nestlé Health Science, Vowst, C.

Diabetes 56

Diabetes Biosimilars 56

PharmaShots

MAY 12, 2023

Difficile Infection at DDW 2023 Date: May 08, 2023 | Tags: Seres Therapeutics, Nestlé Health Science, Vowst, Recurrence of C.

Chemotherapy 40

Chemotherapy Biosimilars Immunity Immunization 40

European Pharmaceutical Review

FEBRUARY 14, 2024

Achieving drug substance and drug product reproducibility is a major challenge to be overcome during product development and clinical supply of live biotherapeutic (LBP) therapies. Clinical supplies Careful consideration is necessary during clinical trial dossier compilation and the setting of drug product specifications.

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Dosage Packaging Compounding Labelling 78

European Pharmaceutical Review

JANUARY 10, 2024

As late-stage clinical development, manufacturing, quality control processes and regulation for microbiome-based treatments evolve, standardisation becomes a critical and complex challenge. Recognition of the potential of manipulating and harnessing the gut microbiome to treat and prevent disease, has seen a wave of clinical trials emerge.

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Immunity Immunization Documentation 52

pharmaphorum

APRIL 26, 2022

Its treatment candidate, known as SER-109, is targeting patients with recurrent C. difficile infection (CDI). The treatment has been granted US FDA breakthrough therapy designation and orphan drug designation, and has also completed a phase 3 clinical study. absolute reduction in the rate of CDI recurrence compared to placebo.

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Immunity Immunization Diabetes Drug Development 115

European Pharmaceutical Review

APRIL 10, 2024

Engaging in continuous dialogue with regulatory bodies in Europe and the US helps in designing clinical trials that follow the latest safety standards and international regulations. During the development of clinical trials that use faecal-derived material, the necessity of safety is paramount.

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Immunity Immunization Chemotherapy Diabetes 84

The Thyroid Pharmacist

OCTOBER 7, 2022

There are not many studies on how stevia affects thyroid hormones, and I’ve never seen any issues with it clinically. There is some conflicting research around whether or not it contributes to the growth of Clostridium difficile ( C. difficile. (39-41) Chatsudthipong V, Muanprasat C. 2022;27(4):1362. 2008.09.007.

Diabetes 95

Diabetes Immunity Immunization Labelling 95

European Pharmaceutical Review

JULY 12, 2023

Integrated safety analysis from five prospective clinical trials for the first and only single-dose, US Food and Drug Administration (FDA)-approved microbiome -based treatment to prevent recurrent Clostridioides difficile ( C. First faecal microbiota product approved for C. diff What did the safety analysis show?

Labelling 97

Labelling 97

The Thyroid Pharmacist

OCTOBER 14, 2022

It has been used clinically for more than 50 years, originally for the prevention and treatment of infectious diarrhea. This includes diarrhea from pathogens (bacteria, viruses, fungi), traveler’s diarrhea, HIV-related diarrhea, antibiotic-associated diarrhea, Clostridium difficile infections, and others. 2,3) That said, S.

Health and Personal Care Stores 104

Health and Personal Care Stores Immunity Immunization Dosage 104

Pharmacy Joe

FEBRUARY 15, 2023

In this episode, I’ll discuss whether recent laxative use should preclude testing for C diff. Episode 792: Should recent laxative use preclude testing for C diff? difficile disease. We encourage hospitals that have not yet embarked on C.

Inpatient 40

Inpatient Hospitals Labelling 40

Pharmaceutical Technology

DECEMBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Ferring Pharmaceuticals’ faecal microbiota product, Rebyota, to prevent Clostridioides difficile infection (CDI) recurrence in people aged 18 years and above. The announcement is not just a milestone for people living with recurrent C.

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European Pharmaceutical Review

JULY 10, 2023

In a world-first clinical trial published Nature Medicine , a multi-centre study found 65 percent of advanced melanoma patients who retained the donors’ microbiome after a faecal microbiota transplants (FMT) had a clinical response to immunotherapy. First faecal microbiota product approved for C. difficile infections.

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pharmaphorum

JANUARY 16, 2023

The fundamentals are compelling: approximately 2% of healthcare expenditure is on IVDs, yet, they are involved with around 66% of clinical decisions and are critical to an improved focus on primary care-centred, patient driven, preventative healthcare. Difficile treatment, Ser-109.

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Pharmaceutical Companies Pharmaceutical Companies Compounding Vaccines 98

ID Stewardship

MARCH 12, 2023

Today I give learners a short list of topics that they must cover during their time with me ( C. difficile , MRSA, UTIs, pneumonia, SSTIs, microbiology fundamentals, stewardship basics/regulations). Article 7: The Future of Medical Guidelines: Standardizing Clinical Care With the Humility of Uncertainty Find it here.

Medication Guidelines 118

Medication Guidelines Documentation Labelling Hospitals 118

European Pharmaceutical Review

MAY 8, 2024

2 Driven by the success of FMTs with clinical efficacy in several indications 3-6 and the first two FDA-approved donor-derived products on the market for recurrent Clostridioides difficile infections, 7,8 a new and promising trend is emerging that combines the ‘whole ecosystem’ of FMTs with rational consortia design.

Medical Schools 65

Medical Schools Drug Development 65

ID Stewardship

OCTOBER 27, 2022

Taking antibiotics not only pressures bacteria to become drug-resistant, it also negatively impacts the host’s microbiome and may lead to a C. difficile infection. Penicillin, which has been in routine clinical use since the 1940s! Myth 13: Polymicrobial infections require multiple antibiotics. Clostridium perfringens ).

Labelling 145

Labelling 145

RX Note

JUNE 3, 2023

A colleague told me that not all pharmacists are professionally trained to perform their clinical service. Is therapeutic monitoring suggested for oral vancomycin in Clostridium difficile infection? Is Good Clinical Practice a requirement prior to starts research? Introduction Learning is a never-ending journey.

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Health and Personal Care Stores Chemotherapy Compounding Dosage 40

FADIC

OCTOBER 20, 2023

A 58-years-old woman (89kg) with a history of hypertension, dyslipidemia, and hypothyroidism, has presented to the Primary Health clinic with Fever and high grade chills, Headache & body-ache, Loose stools, and 2-3 vomiting episodes. Reviewing the current clinical practice on the use of antimicrobial medications. References 1.Chaar,

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Health and Personal Care Stores Documentation Medical Records Hospitals 95

The Thyroid Pharmacist

OCTOBER 28, 2022

This particular probiotic has been clinically studied for ulcerative colitis and irritable bowel syndrome. Allegedly, the inventor left the company, along with his proprietary recipe, and the product that the VSL #3 manufacturer has been making is different than the clinically tested product. Trends Endocrinol Metab. doi:10.1016/j.tem.2019.05.008.

Health and Personal Care Stores 105

Health and Personal Care Stores Immunity Immunization Grocery Stores 105

European Pharmaceutical Review

JANUARY 16, 2023

presented their pathway for regulatory approval to the FDA Vaccines and Related Biological Products Advisory Committee for a faecal microbiota-based live biotherapeutic to treat recurrent Clostridioides difficile infection, which is a major Healthcare Acquired Infection (HAI). Molecular Therapy – Methods & Clinical Development.

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Vaccines Research Laboratories Documentation Compounding 126