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The ID Pipeline: FDA Activity From the Week of December 1, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of December 1, 2019.

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of December 1, 2019.

FDA Clearance a Phase 1 Clinical Trial of MV-012-968 for Respiratory Syncytial Virus

Biotechnology company Meissa Vaccines announced that the FDA has accepted the company’s Investigational New Drug (IND) application to proceed with clinical trial of MV-012-968, an investigational vaccine for respiratory syncytial virus. Meissa plans to initiate a phase 1 clinical trial in adults in 2020 to assess tolerability and immunogenicity of MV-012-968.

“We look forward to beginning our clinical studies to develop a safe and effective RSV [respiratory syncytial virus] vaccine for infants and the elderly,” said Martin Moore, PhD, cofounder and chief executive officer of Meissa in the company’s statement.

Read the press release here.

CURE ID App Crowdsources Information on Difficult-to-Treat Infections

The FDA has announced the launch of a new app that allows clinicians to report novel uses of antibiotics for patients with hard-to-treat infectious diseases.

The app, CURE ID, is intended to crowdsource medical information regarding life-saving interventions with FDA-approved drugs, as well as facilitate the development of novel drugs for neglected infectious diseases. The agency notes that the app is a collaboration between the FDA, the National Center for Advancing Translational Sciences, part of the National Institutes of Health.

In certain circumstances, clinicians may choose to prescribe an approved drug or medical device for an unapproved or uncleared use when it seems medically appropriate for a particular patient. Clinicians can input a simple case report form into the repository using a computer, smartphone, or mobile device.

Read the full article here.

ViiV Healthcare submits New Drug Application for Fostemsavir

ViiV Healthcare, a specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, submitted a New Drug Application to the FDA seeking approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV-1.

Fostemsavir is being developed for use with other antiretrovirals in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a suppressive regimen due to resistance, intolerance, or safety considerations.

Read the press release here.

FDA Grants Marketing Authorization for Novel MRSA Diagnostic Test

The FDA has granted marketing authorization for the cobas vivoDX MRSA diagnostic test. The authorization was granted to Roche Molecular Systems Inc.

The test is a new diagnostic tool that uses bacterial viability and a novel technology to detect bacterial colonization of Methicillin-resistant Staphylococcus aureus (MRSA).

The new test uses bacteriophage technology that is based on bioluminescence to detect MRSA from nasal swab samples. This process can be conducted in as little as 5 hours which expedites the current conventional culturing timeline of 24-48 hours.

Read the full article here.