Biopharma Update on the Novel Coronavirus: August 14

News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.

FDA Actions

EUAs: The FDA issued EUAs for the following.

• LumiraDx SARS-CoV-2 RNA STAR (LumiraDx UK Ltd.)
• Biomeme SARS-CoV-2 Real-Time RT-PCR Test (Biomeme, Inc.)

Warning Letter: The FDA and FTC issued a warning letter to Oxford Medical Instruments USA, Inc. for selling unapproved and misbranded COVID-19-related products.

Warning Letters: The FDA issued warning letters to the following companies because their tests were adulterated and misbranded.

• AkivaMed Inc.
• CoreMedica Laboratories, Inc.
• Fair Price Labs, Inc.
• Holistic Health International, LLC

Diagnostics Update: To-date the FDA has authorized 212 individual EUAs, which include 173 molecular tests, 37 antibody tests and 2 antigen tests.

Testing Therapies, Antivirals and Vaccines

Convalescent antibodies are found in the blood plasma from people who recovered from COVID-19. The results from a three-month study in more than 35,000 patients were published yesterday on a preprint server, which means they have not yet been peer-reviewed. The study was conducted by the Mayo Clinic, Cooper University Health Care, Michigan State University and Johns Hopkins Bloomberg School of Public Health at sites across the country. Patients who received transfusions of convalescent plasma within three days of diagnosis demonstrated a seven-day death rate of 8.7%. Patients who received plasma after four or more days had a mortality rate of 11.9%. This was deemed statistically significant.

A COVID-19 vaccine candidate developed by Chinese pharmaceutical company Sinopharm triggered antibody-based immune responses in early and mid-stage trials. The vaccine candidate, which is now in Phase III development, also appeared to be safe.

While Russian President Vladimir Putin expressed confidence in the preventative medication against the novel coronavirus, scientists from across the globe expressed concern over the lack of available data that could provide a key to how well the drug could work stemming the rise of COVID-19.

Researchers at the University of California, Riverside (UCR) leveraged machine learning to screen more than 10 million commercially available small molecules for interactions with SARS-CoV-2 viral proteins, and found hundreds of drugs that might offer treatments against COVID-19.

UC San Francisco researchers have developed a novel approach to helping stop the spread of the SARS-CoV-2 virus. The team engineered an antiviral, named AeroNabs, to be self-administered with a nasal spray or inhaler to be used once a day. There are active discussions with commercial partners for manufacturing and clinical testing of AeroNabs.

Austin, Texas-based TFF Pharmaceuticals inked a worldwide exclusive licensing deal with Hellerup, Denmark’s UNION Therapeutics for the use of TFF’s Thin Film Freezing technology in combination with niclosamide for COVID-19 treatments.

Company Actions/Announcements

Less than one month after GlaxoSmithKline took a 10% stake in CureVac, the Germany-based company raised $213 million in an initial public offering Thursday. The Tubingen, Germany-based company said it will use the net proceeds from the IPO, as well as a recent private placement of cash, to fund a number of different projects, including the continued development of its mRNA COVID-19 vaccine candidate through Phase III.

Novavax, Inc. entered into an agreement to provide the United Kingdom with 60 million doses of the vaccine should it be approved, as well as a late-stage efficacy study in that country.

As reported by Reuters, Russia indicated the first of its COVID-19 vaccine will be ready for some medical health care providers in two weeks. The vaccine would be administered to volunteers as soon as it is ready.

Other Industry News

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones, including the unusual way the COVID-19 virus infects other cells.