Biopharma Update on the Novel Coronavirus: September 16
News information is not all-inclusive and updates are published on Mondays, Wednesdays and Fridays.
FDA Actions
Research Contract: The FDA awarded a new research contract to the University of Liverpool and global partners. The regulatory science project will sequence and analyze samples from humans and animals to create profiles of various coronaviruses.
Warning Letters: The FDA issued warning letters to two websites, www.extrapharm.com and www.medication-house.com for marketing unapproved COVID-19 products.
Diagnostics Update: To-date the FDA has authorized 249 individual EUAs, which include 198 molecular tests, 47 antibody tests and 4 antigen tests.
Diagnostics
The FDA published comparative performance data for certain authorized COVID-19 molecular diagnostic tests. Please read more here.
Testing Therapies, Antivirals and Vaccines
iBio, Inc. is developing a decoy molecule as a therapeutic against SARS-CoV-2. Recently licensed from Planet Biotechnology, the candidate is a recombinant protein made from human angiotensin converting enzyme 2 (ACE2) fused to a human immunoglobulin G Fc fragment. Read more here.
The National Institutes of Health is raising concern about the safety of AstraZeneca’s coronavirus vaccine, even as the U.S. Food and Drug Administration is weighing whether or not to resume testing in the United States following a global pause in the trial for safety reasons. Please read more here.
Eli Lilly and Company announced interim proof-of-concept data from its BLAZE-1 Phase II clinical trial of LY-COV555, its neutralizing antibody therapy for COVID-19. The study enrolled mild-to-moderate COVID-19 patients who had recently been diagnosed in the outpatient setting and received either placebo, 700 mg, 2800 mg and 7000 mg of the antibody.
NanoViricides announced it has nominated a clinical COVID-19 drug candidate. The candidate, NV-CoV-1-R, is made up of nanoviricide found to have broad-spectrum anti-coronavirus activity.
Researchers at the University of Pittsburg School of Medicine announced they have created a medicine to prevent and treat COVID-19, hoping to begin clinical testing in 2021. The non-vaccine drug is meant to help protect people who are already infected with COVID-19 and is expected to last weeks to months.
Algernon Pharmaceuticals announced the external Data and Safety Monitoring Board unanimously approved the continuation of its multinational Phase IIb/III study of NP-120 (Ifenprodil) for the treatment of COVID-19.
FDA gives The Cura Foundation and The Marcus Foundation, Sanford Health and Alliance for Cell Therapy Now a go-ahead to study human cord tissue mesenchymal stromal cells (hCT-MSC) in children with Multisystem Inflammatory Syndrome in Children (MIS-C), a rare disorder related to COVID-19 infection. The hCT-MSCs are manufactured in the Robertson GMP Cell Manufacturing Laboratory at Duke University.
Company Actions/Announcements
The United Arab Emirates has granted Emergency Use Authorization to an investigational vaccine for the novel coronavirus six weeks after late-stage studies began. The country’s health authority greenlit a vaccine under development by China-based Sinopharm, according to reports.
Only days after saying it expects to have key data from its Phase III clinical trial of its COVID-19 vaccine in October, Germany’s BioNTech received a grant of up to €375 million from the German Federal Ministry of Education and Research (BMBF). The goal is to support the accelerated development of COVID-19 vaccines.
Novavax and Serum Institute of India Private Limited (SIIPL) amended an agreement struck last month that will allow the company to double the number of doses of its experimental COVID-19 vaccine for potential use in 2021.
As reported by Reuters, Russia’s sovereign wealth fund will supply 100 million doses of its potential coronavirus vaccine, Sputnik-V, to Dr Reddy’s Laboratories.
Other Industry News
Although it is increasingly likely that one of the COVID-19 vaccines currently being tested will be approved or receive Emergency Use Authorization (EUA) before the end of the year, experts are increasingly warning that widespread distribution may take a much longer time. Recently, Adar Poonawalla, chief executive officer of the Serum Institute of India, told the Financial Times that drug companies were not scaling up manufacturing capacity fast enough to vaccinate the entire global population. Please read more here.