Infectious Disease

Progress on EBV Vaccine Development Critical for MS Prevention

Research indicates that Epstein-Barr virus (EBV) is a primary trigger for multiple sclerosis (MS), emphasizing the need for an effective vaccine.

FDA Grants AP Status for Clindamycin Phosphate ANDA064050 by Padagis US

The FDA has granted abbreviated approval (AP) status for the ANDA064050 application for Clindamycin Phosphate submitted by Padagis US.

FDA Accepts Supplemental Application for Malarone Pediatric

The FDA has accepted a supplemental application for Malarone Pediatric, containing atovaquone and proguanil hydrochloride.

FDA Approves ANDA for Valacyclovir Hydrochloride by Hetero Labs

The FDA has approved ANDA203047 for Valacyclovir Hydrochloride submitted by Hetero Labs.

Aurobindo Pharma's Cephalexin Receives FDA Approval

Aurobindo Pharma's ANDA213568 for Cephalexin has received FDA approval.

FDA Approves Linezolid in Sodium Chloride 0.9% for Hospira

The FDA has approved Linezolid in Sodium Chloride 0.9% in a plastic container under NDA206473.

FDA Approves Supplemental Applications for ZYVOX by Pfizer

The FDA has approved supplemental applications for ZYVOX (linezolid), indicating ongoing support for this antibiotic.

FDA Approves Supplement for Vancomycin Hydrochloride in Plastic Container

The FDA has approved a supplemental application for Vancomycin Hydrochloride in a plastic container by Baxter Healthcare.

Study on Intestinal TRM Cells and HIV-1 Persistence During ART Launched

A new study aims to characterize intestinal tissue-resident memory T cells in HIV-1 patients on ART, focusing on their role in viral persistence.

Analysis of Oral Nirmatrelvir/Ritonavir Utilization in Spain for COVID-19

The analysis highlights the potential benefits of increasing oral nirmatrelvir/ritonavir use in outpatient settings for high-risk COVID-19 patients in Spain.

Cefazolin Infusion Study Aims to Reduce Surgical Site Infections in Orthopedic Patients

A randomized control trial is evaluating continuous infusion versus intermittent bolus of cefazolin for preventing surgical site infections in orthopedic surgeries.

Study on Genetic Factors in Fungal Infection Susceptibility Launched

A new study aims to investigate immune disorders that increase susceptibility to fungal infections, specifically Candida.

FDA Approves First Generic of Xofluza for Influenza Treatment

The FDA has approved the first generic version of Xofluza, a single-dose treatment for influenza.

FDA Approves First Oral Carbapenem for Complicated UTIs

The FDA has approved the first oral carbapenem therapy specifically for complicated urinary tract infections.

FDA Approves CAPVAXIVE for At-Risk Children and Adolescents

The FDA has approved an expanded indication for CAPVAXIVE to include children and adolescents aged 2-17 at increased risk for pneumococcal disease.

Study on Host-Pathogen Interaction with Staphylococcus aureus Using Lymphoid Organoids

A study is being conducted to understand the interaction between Staphylococcus aureus and human cells using tonsil tissues.

Lupin's Doxycycline ANDA204234 Receives AP Status from FDA

Lupin's Abbreviated New Drug Application (ANDA204234) for Doxycycline has received an Approved Pending (AP) status from the FDA.

R-MVST Cells Show Promise for Treating Refractory Viral Infections

A clinical trial is assessing the safety and feasibility of R-MVST cells for patients with refractory viral infections caused by EBV, CMV, ADV, or BK virus.

OTAC Trial Evaluates Anti-COVID-19 Immunoglobulin in Outpatients

The OTAC trial is assessing the safety and efficacy of hIVIG versus placebo in outpatients with COVID-19.

Merck's ENFLONSIA Approved in EU for RSV Prevention in Infants

The European Commission has approved ENFLONSIA (clesrovimab) as the first RSV preventive option for infants in the EU.

FDA Approves Merck’s IDVYNSO for Virologically Suppressed HIV-1 Patients

Merck's IDVYNSO, a two-drug regimen, has been approved by the FDA for adults with virologically suppressed HIV-1.

mRNA-1083 Shows Durable Immune Response and Safety in Adults ≥50 Years

mRNA-1083 demonstrated durable antibody responses against influenza and SARS-CoV-2 for 6 months with a favorable safety profile.

Merck Receives FDA Approval for IDVYNSO, Expands Oncology Pipeline and Animal Health Sales

Merck has received U.S. FDA approval for IDVYNSO, a once-daily oral treatment for certain adults with virologically suppressed HIV-1.

Lilly expands infectious disease portfolio with three strategic acquisitions

Lilly has announced three acquisitions targeting viral and bacterial pathogens associated with significant health risks.

NextCOVE trial shows mRNA-1283 vaccine elicits higher nAb responses than mRNA-1273

The mRNA-1283 vaccine met non-inferiority criteria against mRNA-1273 and elicited higher neutralizing antibody responses.

Gilead and Merck Report Positive Phase 3 Results for Once-Weekly HIV Treatment Islatravir/Lenacapavir

Gilead and Merck announced positive topline results from two Phase 3 studies for Islatravir/Lenacapavir, a novel oral HIV treatment.

Pfizer's 25vPnC Vaccine Shows Strong Phase 2 Results, Advancing to Phase 3

Nanomaterial-based vaccines show promise for improved rotavirus protection

Nanomaterial-based vaccines could enhance rotavirus vaccine efficacy, particularly in malnourished populations.

GSK's AS03-adjuvanted H5N8 vaccine shows promising immunogenicity and safety in Phase 1/2 trial

The Phase 1/2 trial demonstrated that GSK's AS03-adjuvanted H5N8 vaccine met FDA immunogenicity criteria, with higher immune responses in younger adults.

COVAC-2 Vaccine Shows Safety and Immunogenicity as COVID-19 Booster in Phase 1 Trial

COVAC-2, a recombinant protein vaccine, demonstrated a favorable safety profile and strong immune responses as a booster in previously vaccinated adults.

Clinical Trial Evaluates PRS CK STORM for Cytokine Storm in Respiratory Infections

A clinical trial is assessing the safety and efficacy of PRS CK STORM in patients with cytokine storms from respiratory infections.

4CMenB and MenACWY-CRM Vaccines Co-Administered Safely in Adolescents

A phase 3b study demonstrated that co-administration of 4CMenB and MenACWY-CRM in adolescents is safe and immunogenic.

LIPUS and microbubbles enhance amphotericin B delivery for cryptococcal meningitis therapy

Low-intensity pulsed ultrasound combined with microbubbles significantly increased BBB permeability, enhancing amphotericin B delivery and efficacy against cryptococcal meningitis in a murine model.

FDA Accepts Supplement Application for Artesunate by Amivas

The FDA has accepted a supplemental application for Artesunate (NDA213036) submitted by Amivas.

FDA Grants AP Status for Doxycycline Hyclate Supplement by Impax Labs

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for a supplement of Doxycycline Hyclate submitted by Impax Labs.

South African HCPs Support Dual Prevention Pill but Highlight Key Challenges

Healthcare providers in South Africa support the Dual Prevention Pill (DPP) for HIV and pregnancy prevention but express concerns about daily dosing and side effects.