Ceftriaxone

Basilea reports presentation of new data for ceftobiprole (Zevtera®) at ESCMID Global 2024

Retrieved on: 
Friday, May 3, 2024
Infection, Kidney, FDA, Administration, Staphylococcus, ASPR, HHS, SAB, Safety, Ceftobiprole, Methicillin-resistant Staphylococcus aureus, Food, Ceftriaxone, ESCMID, Daptomycin, Partnership, Fungal infection, Development, CABP, TARGET, ABSSSI, Patient, Staphylococcus aureus, Dialysis, Bronchopneumonia, MRSA, Vaccine

Data presented on a third poster demonstrated that bloodstream clearance was achieved at a median of four days after the start of treatment in both the ceftobiprole and comparator groups.

Key Points: 
  • Data presented on a third poster demonstrated that bloodstream clearance was achieved at a median of four days after the start of treatment in both the ceftobiprole and comparator groups.
  • In the group treated with ceftobiprole, fewer patients had Staphylococcus aureus-positive blood cultures after ten days compared to the comparator treatment group.
  • An oral presentation focused on a re-analysis of the previously conducted ceftobiprole phase 3 study in patients with community-acquired bacterial pneumonia (CABP).
  • Using the FDA-CABP-2020 primary endpoint of early clinical success at day 3 after study start, this re-analysis supported the non-inferiority of ceftobiprole to ceftriaxone ± linezolid.

Innoviva Specialty Therapeutics’ Positive Phase 3 Oral Zoliflodacin Data for the Treatment of Uncomplicated Gonorrhea Announced at ESCMID Global 2024

Retrieved on: 
Wednesday, April 24, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Neisseria gonorrhoeae, Gonorrhea, Randomized controlled trial, World Health Organization, Safety, Woman, ToC, Heart, Ceftriaxone, AMR, ESCMID, Partnership, Zoliflodacin, Azithromycin, Patient, Physician, IM, Failure, HIV, Infection, Clinical trial, Therapy, Organization, Prevalence, Cohort (statistics), Pharmaceutical industry

Zoliflodacin is a first-in-class spiropyrimidinetrione, single dose, oral antibiotic that is being developed in partnership with GARDP for the treatment of uncomplicated gonorrhea.

Key Points: 
  • Zoliflodacin is a first-in-class spiropyrimidinetrione, single dose, oral antibiotic that is being developed in partnership with GARDP for the treatment of uncomplicated gonorrhea.
  • GARDP and Innoviva Specialty Therapeutics plan to submit the Phase 3 zoliflodacin data for future publication in a medical journal.
  • Oral zoliflodacin 3g was generally well tolerated and emergent adverse events were comparable between treatment arms (46.2% vs 46.4%).
  • Details for the ESCMID Global 2024 presentations are as follows:
    Title: Oral zoliflodacin is non-inferior to a combination of ceftriaxone and azithromycin for treatment of uncomplicated urogenital gonorrhoea: results of a large global Phase 3 randomized controlled trial
    Session: 05.

FDA Approves New Antibiotic for Three Different Uses

Retrieved on: 
Wednesday, April 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.

Intravacc Awarded US$ 633K CARB-X Funding to Develop a Vaccine that Prevents Gonorrhea Infections

Retrieved on: 
Tuesday, January 16, 2024
Development, Agreement, Patient, Infection, Ceftriaxone, Infertility, Social work, Science, Gonorrhea, STI, Administration, Pelvic inflammatory disease, Vaccination, Bill, Risk, Education, Bacteria, Neisseria gonorrhoeae, Disease, BMBF, Doctor of Philosophy, HIV, Human services, Vaccine, Chronic pain, DHSC, OMV

The Neisseria gonorrhoeae bacterium causes gonorrhea, the second most reported bacterial STI.

Key Points: 
  • The Neisseria gonorrhoeae bacterium causes gonorrhea, the second most reported bacterial STI.
  • Patients with gonorrhea can face serious health effects, including pelvic inflammatory disease, chronic pain, infertility, and an increased risk of contracting HIV.
  • Through the tailored gonococcal antigens on the surface of the meningococcal OMV, Intravacc anticipates a significant enhancement in the vaccine candidate’s efficacy against gonorrhea.
  • “This CARB-X project allows us to combine our science and OMV expertise for the development of a vaccine against gonorrhea infections.

Recce Pharmaceuticals Reports Positive Preclinical Data of RECCE® 327 Against Gonorrhea

Retrieved on: 
Monday, December 18, 2023
ASX, RCE, Risk, WHO, Ageing, Vaginitis, Mouse, Gonorrhea, Infection, Neisseria gonorrhoeae, Azithromycin, World Health Organization, Safety, Ceftriaxone, Vaccine

“The need for a new class of anti-infectives could not be greater, especially against a sometimes lethal pathogen, such as N. gonorrhoeae,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.

Key Points: 
  • “The need for a new class of anti-infectives could not be greater, especially against a sometimes lethal pathogen, such as N. gonorrhoeae,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.
  • After three days, the mice treated with R327 showed an approximate 4-log (99.99%) reduction in bacterial shedding, demonstrating significant bactericidal activity.
  • After five days of treatment, R327 showed a 3.5-log (>99.9%) reduction in bacterial shedding compared to the placebo-treated group.
  • A late-stage preclinical study comparing IV administration to a topical application of R327 against N. gonorrhoeae is underway.

Combination Antibiotic Therapies May Be Capable of Eradicating Lyme Disease, According to Investigational Study Funded by Bay Area Lyme Foundation

Retrieved on: 
Tuesday, November 21, 2023
Tulane University, Infection, Clofazimine, Cefotaxime, Research, FDA, Dapsone, Chronic pain, Fatigue, Lyme disease, Carbomycin, Borrelia burgdorferi, Patient, Bacteria, Doxycycline, Loratadine, Ceftriaxone, DSM-IV codes, Frontiers

These combination therapies were able to eradicate the bacteria from tissue samples, and the study was conducted by Bay Area Lyme Foundation Scientific Advisory Board member Monica Embers Ph.D. , along with other researchers from Tulane University.

Key Points: 
  • These combination therapies were able to eradicate the bacteria from tissue samples, and the study was conducted by Bay Area Lyme Foundation Scientific Advisory Board member Monica Embers Ph.D. , along with other researchers from Tulane University.
  • While none of the single courses of antibiotics eliminated persistent infection in this investigational study, some combinations of already FDA-approved antimicrobial treatments were able to eradicate the bacteria.
  • Previous studies funded by Bay Area Lyme Foundation also found other compounds, including natural botanicals, to show promise in killing Borrelia burgdorferi and superiority over commonly prescribed antibiotics in laboratory research.
  • This study was made possible by Bay Area Lyme Foundation’s science research grant program, which includes support from Project Lyme .

Positive Results Announced in Largest Pivotal Phase 3 Trial of a First-in-Class Oral Antibiotic to Treat Uncomplicated Gonorrhea

Retrieved on: 
Wednesday, November 1, 2023
Health, Infectious Diseases, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Grand duchy, Food, Face, VWS, Disease, Gonorrhea, MHLW, Partnership, The Lancet, National Rural Development Partnership, Infection, Nursing care plan, Reproduction, SAMRC, Azithromycin, Hope, Physician, Prevalence, HIV, Ceftriaxone, BMBF, Neisseria gonorrhoeae, University, Therapy, Patient, Food and Drug Administration, Infertility, DFID, Heart, BMG, NIAID, MD, DHSC, AMR, BZ, Clinical trial, World Health Organization, Zoliflodacin, Woman, Multidrug-resistant bacteria, FOPH, South African Medical Research Council, Death, Ministry, Pharmaceutical industry, Vaccine, Medicine

These positive preliminary findings offer hope for patients with this condition, particularly in the face of rising antibiotic resistance to current regimens.

Key Points: 
  • These positive preliminary findings offer hope for patients with this condition, particularly in the face of rising antibiotic resistance to current regimens.
  • It also paves the way for a new research and development model in the global fight against antimicrobial resistance (AMR).
  • Now, the positive results of this landmark Phase 3 trial confirm that zoliflodacin has the potential to tackle the most difficult-to-treat gonorrhea infections.
  • This builds on the critical Phase 2 clinical trial sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID).

Innoviva Reports Third Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Wednesday, November 1, 2023
Health, Infectious Diseases, Hospitals, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Acinetobacter, CGMP, NYSE, Infection, Sulbactam, Exercise, Death, Ceftriaxone, Disease, Zoliflodacin, Gonorrhea, GSK, Investment, Therapy, Patient, National Rural Development Partnership, Music, Pharmaceutical industry, Security (finance)

Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a portfolio of royalties and other healthcare assets, today reported financial results for the third quarter ended September 30, 2023, highlighted select corporate achievements and provided an overview of its key business initiatives.

Key Points: 
  • Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or the “Company”), a diversified holding company with a portfolio of royalties and other healthcare assets, today reported financial results for the third quarter ended September 30, 2023, highlighted select corporate achievements and provided an overview of its key business initiatives.
  • "The third quarter of 2023 was marked by significant revenues stemming from our royalty portfolio and solid performance by our internal product portfolio,” said Pavel Raifeld, Chief Executive Officer of Innoviva.
  • During the third quarter of 2023, Innoviva repurchased 856,750 shares of its outstanding common stock for $11.0 million.
  • On August 21, 2023, Innoviva appointed Stephen Basso as Chief Financial Officer.

Amneal Receives U.S. FDA Approval for Calcium Gluconate Injection

Retrieved on: 
Wednesday, September 6, 2023
Biotechnology, FDA, Pharmaceutical, Health, Ceftriaxone, Abbreviated New Drug Application, Sodium chloride, CGT, Senior, Hypocalcemia, Calcium gluconate, Medication, U.S. FDA, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Food, Pharmaceutical industry, Dietary supplement

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for calcium gluconate in sodium chloride injection, 1000 mg/50 mL and 2000 mg/100 mL.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for calcium gluconate in sodium chloride injection, 1000 mg/50 mL and 2000 mg/100 mL.
  • Key Warning: Concomitant use of ceftriaxone and Calcium Gluconate in Sodium Chloride Injection is contraindicated in neonates (28 days of age or younger.)
  • “The approval of calcium gluconate injection, a key injectable in shortage, reflects our commitment to addressing immediate patient needs for essential medicines.
  • According to IQVIA®, U.S. annual sales for calcium gluconate in sodium chloride injection for the 12 months ended June 2023 were $107 million.

Healthcare Industry Veteran Jamie Condie Joins Selux Diagnostics' Board of Directors

Retrieved on: 
Tuesday, February 14, 2023
Hand, Physician, Hospital, Tetracycline, MDR, Ciprofloxacin, Ceftriaxone, Food and Drug Administration, Food, AMR, Cefixime, AST, FDA, Infection, Microbiology, Bacteria, Azithromycin, Gonorrhea, Antimalarial medication, NGP, Pharmaceutical industry, Vaccine

BOSTON, Feb. 14, 2023 (GLOBE NEWSWIRE) -- Selux Diagnostics, a biotech startup in Boston whose mission is to combat superbug infections and antimicrobial resistance (AMR), announced today that healthcare industry veteran Jamie Condie has joined the company's Board of Directors.

Key Points: 
  • BOSTON, Feb. 14, 2023 (GLOBE NEWSWIRE) -- Selux Diagnostics, a biotech startup in Boston whose mission is to combat superbug infections and antimicrobial resistance (AMR), announced today that healthcare industry veteran Jamie Condie has joined the company's Board of Directors.
  • "Selux has emerged as a clear leader in the global fight against antibiotic resistance by redefining the speed and performance of AST.
  • With FDA clearance in hand, Selux can now share its Next Generation Phenotyping technology with the industry to transform the treatment of infectious disease," said Condie.
  • As we bring the fastest AST platform with a future-proof antibiotic menu to bear on this problem, we are fortunate to have Jamie join Selux's Board of Directors," said Steve Lufkin, CEO of Selux.