Clostridioides

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

Retrieved on: 
Tuesday, March 5, 2024

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: 
Tuesday, February 13, 2024

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: 
Sunday, January 14, 2024

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: 
Wednesday, January 10, 2024

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: 
Tuesday, January 9, 2024

“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: 
Saturday, December 30, 2023

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: 
Friday, December 22, 2023

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.

Phathom Pharmaceuticals Announces FDA Acceptance for Filing of VOQUEZNA® (vonoprazan) Tablets New Drug Application for the Treatment of Heartburn Associated with Non-Erosive GERD

Retrieved on: 
Wednesday, December 6, 2023

The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024.

Key Points: 
  • The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024.
  • “Non-Erosive GERD represents a substantial segment of the U.S. GERD population, affecting millions of individuals and impacting their quality of life.
  • Symptoms impact overall quality of life and can include episodic heartburn, especially at night, regurgitation, problems swallowing, and chest pain.
  • for the maintenance of healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD in adults.

Phathom Pharmaceuticals Announces Commercial Availability of VOQUEZNA® (vonoprazan) Tablets, a Powerful First-In-Class PCAB for the Treatment of Erosive GERD and Relief of Associated Heartburn

Retrieved on: 
Tuesday, November 28, 2023

“We are thrilled to announce the commercial availability of our first-in-class medication, VOQUEZNA, now available for the millions of people in the U.S. suffering from Erosive GERD,” said Martin Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals.

Key Points: 
  • “We are thrilled to announce the commercial availability of our first-in-class medication, VOQUEZNA, now available for the millions of people in the U.S. suffering from Erosive GERD,” said Martin Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals.
  • “Erosive GERD is a highly prevalent condition affecting over 20 million people in the U.S.,3,4 many of whom experience troubling symptoms, including painful heartburn.
  • Phathom is offering programs for eligible patients who face coverage or affordability issues, including co-pay assistance for patients with commercial insurance.
  • for up to 6 months to maintain healing of Erosive Acid Reflux and for relief of heartburn related to Erosive Acid Reflux.

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

Retrieved on: 
Monday, December 18, 2023

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