The ID Pipeline: FDA Activity From the Week of February 16, 2020


Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of February 16, 2020.

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of February 16, 2020.

Matinas BioPharma Receives Approval to Commence Cryptococcal Meningitis Study

Matinas Biopharma announced that an independent data safety monitoring board for the EnACT study completed its review of initial safety and tolerability data from part 1 of the MAT2203 Oral Amphotericin B treatment of cryptococcal meningitis.

The monitoring board unanimously approved of the trial proceeding to enrollment for the part 2 efficacy phase. Part 2 of the study will investigate the use of MAT2203 for induction and maintenance therapy in HIV-patients with cryptococcal meningitis.

Read the press release.

3D Atomic Map Leads to Coronavirus Vaccine Effort Breakthrough

Researchers from the University of Texas at Austin and the National Institutes of Health created the first 3D atomic scale map of the spike protein of the novel coronavirus (SARS-CoV-2).

The spike protein is the part of the virus which attaches to and infects human cells. The development is an essential part of developing a vaccine to protect against SARS-CoV-2 infection. Results were published in Science.

Read the press release.

Aalto Bio Reagents Announces Availability of Coronavirus Nucleocapsid Protein

Aalto Bio Reagents has announced the availability of the recombinant SARS-CoV-2 nucleocapsid protein code CK 6404 to vaccine developers, researchers, and diagnostic manufacturers.

The company believes the nucleocapsid protein may assist in developing tests that detect cases which polymerase chain reaction (PCR) diagnostics may miss.

“Patients are currently being screened for the virus by PCR, however there is an important need for serological tests as well to detect all those mild or even asymptomatic cases that may otherwise be missed,” said Philip Noone, CEO of Aalto Bio Reagents.

Read the press release.

HHS Engages Sanofi’s Recombinant DNA Platform For COVID-19 Vaccine

In order to further development of a vaccine against the 2019 novel coronavirus, the US Department of Health and Human Services (HHS) will work with Sanofi Pasteur, the vaccines global business unit of Sanofi.

HHS will provide expertise and funding to assist Sanofi in developing a vaccine candidate using its egg-free, recombinant DNA platform.

Read the press release.

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