Clostridioides

Seres Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates

Retrieved on: 
Mercoledì, Maggio 8, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Oaktree Capital Management, Sale, FDA, Variometer, Gastroenterology, David Berry (inventor), Acceleration, Safety, Clostridioides, Risk, Commercial, Research, Chronic liver disease, Recurrence, Cohort, Fast track (FDA), ATM, Clostridioides difficile infection, Allo, GI, Therapy, Data, Patient, Infection, CDI, HSCT, ID, G&A, Pharmaceutical industry

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today reported first quarter 2024 financial results and provided business updates.

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today reported first quarter 2024 financial results and provided business updates.
  • These clinical results could further validate the vast potential of microbiome therapeutics in preventing adverse outcomes linked to gastrointestinal pathogens,” continued Mr. Shaff.
  • In the first quarter of 2024, approximately 1,411 completed prescription enrollment forms were received for VOWST and there were approximately 1,083 new patient starts.
  • Seres’ share of the VOWST net loss for the first quarter of 2024 was $7.1 million, which was included in the Company’s operating results within Collaboration (profit) loss sharing—related party.

Phathom Pharmaceuticals Launches Direct-to-Consumer Campaign, “VOQUEZNA Can Kick Some Acid”

Retrieved on: 
Martedì, Marzo 26, 2024
Connected, HIV-1, Amazon Prime Video, Breast milk, Face, Hypoesthesia, Patient, Chronic pain, Clostridioides, Heartburn, Lymph, Magnesium, Diarrhea, Myalgia, Spine, Allergy, Muscle weakness, Vonoprazan, Stomach, Vitamin, Dizziness, Potassium, Hip, Risk, Tongue, Chills, DTC, Safety, Food, PPI, Rash, Food and Drug Administration, GERD, Enzyme inhibitor, Skin, Esophagitis, HIV, Rilpivirine, Kidney, FDA, Esophagus, B-12, Weakness, Infection, Indigestion, Smart TV, Seizure, Inflammation, Polyp, Calcium, Extrapyramidal system, Bone fracture, Nausea, Spasm, Urine, Fever, Clostridioides difficile, Bleeding, Blood, Wrist, Blister, Vitamin B12, Human, Medicine, Pharmaceutical industry

FLORHAM PARK, N.J., March 26, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announces the launch of its new broadcast ad and full-scale, Direct-to-Consumer (DTC) campaign, “VOQUEZNA Can Kick Some Acid,” to raise awareness of its powerful first-in-class treatment and encourage people to speak to their doctor about this new treatment option. VOQUEZNA (vonoprazan) is indicated for the healing and maintenance of healing of all severities of Erosive Esophagitis (EE), also referred to as Erosive GERD, and for the relief of related heartburn. VOQUEZNA represents the first major innovation to the U.S. Erosive GERD market in over 30 years.1

Key Points: 
  • The campaign will also be featured on consumer-facing platforms across Facebook, Instagram, waiting room TVs in doctor offices, and digital banner ads.
  • “Phathom is excited to launch our first campaign directly to, and for, the people whose lives we strive to improve every day.
  • To view a video of the “VOQUEZNA Can Kick Some Acid” commercial, click here.
  • Talk with your healthcare provider about the possibility of fundic gland polyps if you have been on VOQUEZNA for a long time.

FDA Approves New Antibiotic for Three Different Uses

Retrieved on: 
Mercoledì, Aprile 3, 2024
Daptomycin, Research, Hypersensitivity, Hypokalemia, Fungal infection, Aztreonam, Dizziness, Pneumonia, Survival, Dysgeusia, Potassium, Seizure, Abdominal pain, Dietary supplement, CABP, Headache, Patient, Public, Insomnia, Bacterial pneumonia, Food and Drug Administration, Animal, Bilirubin, Diarrhea, History, Mortality, Vancomycin, Leukopenia, Clostridioides, Human services, Injection site reaction, Nausea, Rash, Priority review, Bronchopneumonia, Skin, Fever, Heated tobacco product, Ceftriaxone, Safety, SAB, Anemia, Division, Phlebitis, Cosmetics, Vaccine, Infection, Food, Vomiting, Blood, Multimedia, FDA, Periodic breathing, ABSSSI, Pharmaceutical industry

"The FDA will continue our important work in this area as part of our efforts to protect the public health."

Key Points: 
  • "The FDA will continue our important work in this area as part of our efforts to protect the public health."
  • Zevtera's efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial .
  • In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects).
  • A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.

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

Retrieved on: 
Martedì, Marzo 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.

Phathom Pharmaceuticals Announces VOQUEZNA® (vonoprazan) Tablets for Erosive GERD and Associated Heartburn Added to Express Scripts National Formularies for Commercial Patients

Retrieved on: 
Martedì, Febbraio 13, 2024
Urinary tract infection, Gastroesophageal reflux disease, Research, Heartburn, Toxicity, Magnesium, Polyp, Liver, CYP, CGA, Achlorhydria, Esophagitis, Patient, PBM, Vitamin B12, Vonoprazan, Kidney, Spine, Lactation, Absorption, Hypokalemia, SCAR, Calcium, Express Scripts, TIN, Endoscopy, Tablet, Express, Magnesium deficiency, Hypocalcemia, Diarrhea, Hypersensitivity, Physician, Gastritis, Malabsorption, GERD, PPI, Hypertension, SJS, Enzyme inhibitor, EGFR, Stevens–Johnson syndrome, Indigestion, Nelfinavir, Clostridioides, Abdominal pain, Hip, Pharmacy, Enzyme, Glomus tumor, FDA, CDAD, Atazanavir, Risk, BMJ Open, Wrist, Drug, Impairment, Pharmaceutical industry

Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.

Key Points: 
  • Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.
  • doi:10.1136/ bmjgast-2022-000941
    VOQUEZNA® (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated:
    for the healing of all grades of Erosive Esophagitis (Erosive Gastroesophageal Reflux Disease or Erosive GERD) and relief of heartburn associated with Erosive GERD in adults.
  • for the maintenance of healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD in adults.
  • Renal Impairment: For the healing of Erosive GERD, dosage reduction is recommended in patients with severe renal impairment (eGFR

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

Retrieved on: 
Domenica, Gennaio 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

Organon’s XACIATO™ (clindamycin phosphate) Vaginal Gel 2% Available Nationwide to Treat Bacterial Vaginosis (BV) in Females Aged 12 and Older

Retrieved on: 
Mercoledì, Gennaio 10, 2024
Health, Consumer, Women, General Health, Pharmaceutical, Biotechnology, CDAD, Development, Woman, Hydrogen chloride, Hypersensitivity, Patient, OGN, Frustration, Thermoregulation, Gynaecology, History, Bacterial vaginosis, Clostridioides, Environment, Recurrence, Research and development, BV, Bacteria, Clindamycin, Lincomycin, Infection, American College

Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced that XACIATO™ (clindamycin phosphate) vaginal gel 2% is available by prescription to treat bacterial vaginosis (BV).

Key Points: 
  • Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced that XACIATO™ (clindamycin phosphate) vaginal gel 2% is available by prescription to treat bacterial vaginosis (BV).
  • Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
  • If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued.
  • Information about XACIATO, and the eVoucher instant savings coupon for eligible patients, can be found at XACIATO.com .

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

Retrieved on: 
Martedì, Gennaio 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

Retrieved on: 
Sabato, Dicembre 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

Immuron Clinical Trials Update

Retrieved on: 
Venerdì, Dicembre 22, 2023
Spore, Clostridioides difficile, ASX, Immuron, Principal, Diarrhea, FDA, NMRC, Campylobacter, IMC, Johns Hopkins University, Trial of the century, MD, Agriculture, Clinical trial, GLP, Volunteering, Escherichia, Escherichia coli, CIR, CHIM, Patient, Monash University, Safety, JHU, Clostridioides, Pharmaceutical industry

MELBOURNE, Australia, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company is pleased to provide shareholders and the market with an update on the company’s clinical development portfolio.

Key Points: 
  • The NMRC has recently completed the in-patient stage of the campylobacter challenge clinical study.
  • Headline results from the clinical trial are anticipated to be reported in H2 2024.
  • The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of the new product manufactured by Immuron compared to a placebo in a controlled human infection model (CHIM).
  • The inpatient challenge phase of the Travelan clinical study led by Principal Investigator Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US, has been completed.