Clostridioides difficile infection

Global Microbiome Manufacturing Markets 2023-2024 & 2035: Industry Trends, Forecasts, Formulation, Primary Packaging Used, Scale of Operation, Company Size, Key Regions and Leading Developers - ResearchAndMarkets.com

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Friday, April 5, 2024
Vitamins, Supplements, Neurology, Fitness & Nutrition, Clinical Trials, Other Health, Biotechnology, Alternative Medicine, General Health, Pharmaceutical, Health, Clostridioides difficile infection, Type, Organization, Database, AOBiome, Microbiota, Patient, CNS, CGMP, Research, Fungus, FDF, Bacteria, Virus, Laboratory, Overalls, Infection, DSM-IV codes, API, Safety, Phase, Therapy, USD, LBP

Likewise, the ecological system of commensal, symbiotic, and pathogenic microorganisms that reside within a host system is called the microbiome.

Key Points: 
  • Likewise, the ecological system of commensal, symbiotic, and pathogenic microorganisms that reside within a host system is called the microbiome.
  • Further, this microbiome manufacturing market analysis highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry.
  • Around 43% of the global microbiome contract manufacturing capacity is installed in facilities owned by small contract manufacturing companies.
  • This market report includes an easily searchable excel database of all the microbiome contract manufacturing companies and their manufacturing facility, worldwide.

Recursion Provides Business Updates and Reports Fourth Quarter and Fiscal Year 2023 Financial Results

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Tuesday, February 27, 2024
FAP, Senior, Research, FPI, Chemistry, Neuroscience, AXIN1, Part, Death, LLM, Software as a service, Hemangioma, Genetics, Cancer, Software, Letter, Business operations, Data, Matchmaker, APC, Machine learning, Real space, Biology, Development, Partnership, Therapy, Enamine, CCM, Myrexis, Library, Drug discovery, Safety, Biomarker, Clinical trial, IND, Clostridioides difficile infection, Roche, NF2, Biotechnology, Neurofibromatosis type II, Trial of the century, LILAC, Disease, Myriad Genetics, Administration, Pharmaceutical industry

SALT LAKE CITY, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Recursion (Nasdaq: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today reported business updates and financial results for its fourth quarter and fiscal year ending December 31, 2023.

Key Points: 
  • SALT LAKE CITY, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Recursion (Nasdaq: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today reported business updates and financial results for its fourth quarter and fiscal year ending December 31, 2023.
  • Research and Development Expenses: Research and development expenses were $69.5 million for the fourth quarter of 2023, compared to $44.0 million for the fourth quarter of 2022.
  • General and Administrative Expenses: General and administrative expenses were $30.5 million for the fourth quarter of 2023 compared to $19.8 million for the fourth quarter of 2022.
  • Net Loss: Net loss was $93.0 million for the fourth quarter of 2023, compared to a net loss of $57.5 million for the fourth quarter of 2022.

Seres Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates

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Tuesday, March 5, 2024
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Fast Track, Therapy, HCP, Chronic liver disease, David Berry (inventor), Recurrence, Clostridioides difficile infection, Infection, Research, Fast track (FDA), Education, FDA, Term loan, Variometer, Growth, Use, Retirement, ID, Sale, CDI, Immunodeficiency, Oaktree Capital Management, Risk, Commercial, Graft-versus-host disease, Intensive care medicine, Medicare, Spore, Patient, Medicare Part D, Acceleration, Gastroenterology, Clostridioides, Limitation, AMR, Pharmaceutical industry

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today reported fourth quarter and full year 2023 financial results and provided business updates.

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today reported fourth quarter and full year 2023 financial results and provided business updates.
  • From launch through year-end 2023, there were 2,833 completed prescription enrollment forms received for VOWST, of those 2,015 resulted in new patient starts by year-end 2023.
  • Strong adoption of VOWST since commercial launch in June 2023 with broad utilization, continued quarter over quarter growth, and significant progress achieving patient access.
  • General and administrative expenses for the fourth quarter of 2023 were $17.2 million, compared with $22.4 million for the same period in 2022.

Global Microbiome Research Report 2023: Market Booming with Breakthrough Treatments for Recurrent C. Difficile Infection, Fecal Microbial Transplantation (FMT) Emerges as a Game-Changer - ResearchAndMarkets.com

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Wednesday, February 21, 2024
Biotechnology, Pharmaceutical, Health, Therapy, Marketing, Algorithm, Biomarker, Clostridioides difficile infection, Agriculture, David Berry (inventor), Livestock, Research, Recurrence

The microbiome therapeutics market is successfully commercializing Seres Therapeutics' SER-109 and Rebiotix's RBX-2660 for recurrent Clostridium difficile infection (Recurrent C. difficile).

Key Points: 
  • The microbiome therapeutics market is successfully commercializing Seres Therapeutics' SER-109 and Rebiotix's RBX-2660 for recurrent Clostridium difficile infection (Recurrent C. difficile).
  • While integrated omics-based projects are underway, researchers focus more on differences in gut microbiota between individuals that may be associated with disease expression.
  • This report covers the efforts of companies involved in the microbiome market.
  • Trends in the global microbiome market are also summarized by country (and some areas), and the current market size, competitive landscape, and challenges are analyzed and forecasted for the future.

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation of NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis

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Tuesday, January 16, 2024
Intellectual property, Death, Clostridioides difficile infection, Patient, Research, DSM-IV codes, Hospital, Health, Urine, Dark Enlightenment, Colitis, Tuberculosis, UTI, Clostridioides difficile, DCS, Tetracycline, QIDP, Risk, Infection, Cephalosporin, Pulmonary fibrosis, Sepsis, FDA, Priority review, Penicillin, New Drug Application, Pyelonephritis, Urinary tract infection, Literature, Contra, NMDA, CNS, Pharmaceutical industry

Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position.

Key Points: 
  • Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position.
  • The FDA also granted NRX-101 Fast Track designation for cUTI, which additionally allows for rolling submission of the Company's New Drug Application.
  • On the basis of this advance, NRx is seeking partners with active involvement in urology, infectious disease and/or women's health for commercialization of NRX-101.
  • NRx thanks the US FDA for its rapid award of QIDP designation for cUTI and pyelonephritis.

Summary of opinion: Zinplava, 14/12/2023 Positive

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Sunday, January 14, 2024
Clostridioides difficile infection, Medication package insert, Patient, CHMP, Bezlotoxumab, Civil service commission, European Commission, Clostridioides, Recurrence, CDI, Marketing, Committee, Pharmaceutical industry

On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Zinplava.

Key Points: 
  • On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Zinplava.
  • The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.
  • The CHMP adopted an extension to the existing indication to include treatment of paediatric patients from 1 to 18 years of age.
  • 1New text in bold, removed text as strikethrough

Seres Therapeutics Announces VOWST™ Commercial Launch Update and US FDA Fast Track Designation for SER-155

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Tuesday, January 9, 2024
FDA, Infectious Diseases, Health, Stem Cells, Clinical Trials, Clostridioides difficile infection, Graft-versus-host disease, Patient, Therapy, Incidence, Growth, Oaktree Capital Management, Medicare, Spore, Commercial, HCP, Clostridioides, Risk, Recurrence, Variometer, Immunodeficiency, Investment, CDI, Conference, Drug development, Medicare Part D, Fast track (FDA), Term loan, David Berry (inventor), Infection, Education, Pharmaceutical industry

“In 2023, VOWST received FDA approval with a broad indication, which includes use in first recurrence patients.

Key Points: 
  • “In 2023, VOWST received FDA approval with a broad indication, which includes use in first recurrence patients.
  • The SER-155 Cohort-2 readout is expected in the third quarter, and we are excited to announce receipt of Fast Track Designation for SER-155 to reduce the risk of infection and GvHD in allo-HSCT patients.
  • Production of VOWST commercial supply enabled a strong commercial launch within weeks of approval; progress in expansion of VOWST manufacturing capacity.
  • To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch .

Summary of opinion: Zinplava, 14/12/2023 Positive

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Saturday, December 30, 2023
Marketing, European Commission, CDI, Recurrence, Civil service commission, Bezlotoxumab, Medication package insert, Clostridioides difficile infection, Committee, Patient, Clostridioides, CHMP, Pharmaceutical industry

On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Zinplava.

Key Points: 
  • On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Zinplava.
  • The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.
  • The CHMP adopted an extension to the existing indication to include treatment of paediatric patients from 1 to 18 years of age.
  • 1New text in bold, removed text as strikethrough

Summary of opinion: Zinplava, 14/12/2023 Positive

Retrieved on: 
Monday, December 18, 2023
CDI, Bezlotoxumab, European Commission, Civil service commission, Patient, Medication package insert, CHMP, Marketing, Committee, Recurrence, Clostridioides difficile infection, Clostridioides, Pharmaceutical industry

On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Zinplava.

Key Points: 
  • On 14 December 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Zinplava.
  • The marketing authorisation holder for this medicinal product is Merck Sharp & Dohme B.V.
  • The CHMP adopted an extension to the existing indication to include treatment of paediatric patients from 1 to 18 years of age.
  • 1New text in bold, removed text as strikethrough

Modine Introduces VidaShield™ UV24 Active Air Disinfection System to K-12 School Markets

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Wednesday, December 6, 2023
Ventilation, NYSE, Catalog, Engineering, Dust, Pneumonia, Atmosphere of Earth, Student, Measles, Fungus, Marketing strategy, Mumps, COVID-19, MRSA, Bacteria, University, School, Virus, UVGI, CDC, Atmosphere, SARS-CoV-2, IAQ, HVAC, Filtration, Clostridioides difficile infection, Sewage treatment, Modine, Tuberculosis

RACINE, Wis., Dec. 6, 2023 /PRNewswire/ -- Modine (NYSE: MOD), a technology and indoor air quality leader in the HVAC industry, is now offering the VidaShield™ UV24 Active Air Disinfection System product line to the K-12 school market. This innovative solution will further help equip schools with the necessary tools to combat airborne pathogens.

Key Points: 
  • Innovative 24/7 air disinfection system combines germicidal irradiation with air circulation fans to help improve IAQ in schools.
  • RACINE, Wis., Dec. 6, 2023 /PRNewswire/ -- Modine (NYSE: MOD), a technology and indoor air quality leader in the HVAC industry, is now offering the VidaShield™ UV24 Active Air Disinfection System product line to the K-12 school market.
  • VidaShield™ UV24 is a fast, continuous air disinfection system that combines an ultraviolet germicidal irradiation (UVGI) chamber and air circulating fans with an optional overhead ceiling light, making it convenient for schools, universities and daycare centers.
  • For more information about the VidaShield™ UV24 Active Air Disinfection System, please visit https://vidashield.com/ .