Biopharma Update on the Novel Coronavirus: July 31

CV Update_July 31

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

 

FDA Actions

FAQs for Remdesivir: The FDA updated its FAQs on the use of remdesivir for certain hospitalized patients.

Diagnostics Update: To-date the FDA has authorized 193 individual EUAs, which include 158 molecular tests, 33 antibody tests and 2 antigen tests.

 

Diagnostics 

The U.S. Food and Drug Administration (FDA) issued a new template for clinical test developers that is designed to assist these companies in developing and submitting emergency use authorization (EUA) for COVID-19 tests that can be performed at home or in other settings besides laboratories. In addition, these tests could be sold without a prescription.

Quest Diagnostics announced the FDA granted a EUA for a new lab technique that accelerates the COVID-19 testing process and will enable the company to expand its daily capacity of molecular diagnostic tests in the U.S.

The U.S. Federal Emergency Management Agency (FEMA) paid $7.3 million to Florida-based Fillakit on May 7, 2020. It was no-bid contract for COVID-19 clinical laboratory testing supplies. However, the Fillakit specimen tubes appeared to be “preforms” that are designed to be expanded with heat and pressure into 2-liter soda bottle. They were not lab specimen tubes and were not usable.

 

Testing Therapies, Antivirals and Vaccines

Merck is joining the ranks of pharmaceutical companies that have a COVID-19 vaccine candidate in clinical development. Merck will move its candidate into clinical trials in the third quarter of this year, the company announced this morning.

Johnson & Johnson’s experimental COVID-19 vaccine candidate generated neutralizing antibodies in preclinical studies. The announcement comes days after the life sciences giant initiated a Phase I/IIa clinical study of its vaccine candidate, Ad26.COV2.S.

Tiziana Life Sciences announced it has submitted a patent application for nasally administrated Foralumab, a fully human anti-CD3 monoclonal antibody (mAb), for the treatment of COVID-19.

A group of researchers, technologists, or “science enthusiasts,” some with connections to Harvard University or MIT, have formed the Rapid Deployment Vaccine Collaborative (Radvac), created their own do-it-yourself COVID-19 vaccine and have begun testing it on themselves. The vaccine was developed by Preston Estep, a former graduate student of Harvard University geneticist George Church. Estep is the cofounder of Veritas Genetics. Church is one of the people who has taken the vaccine in two doses about a week apart.

In an interview with NBC’s Today, the Commissioner of the U.S Food and Drug Administration (FDA) said, “We will not cut corners. We will use our very high standards of safety and effectiveness,” for approving a coronavirus vaccine. Hahn said there could be a vaccine by the end of the year.

Edesa Biotech announced it has filed an investigational new drug (IND) application with the FDA for the initiation of a Phase II/III clinical trial for its drug, EB05 for the treatment of hospitalized COVID-19 patients.

Moncef Slaoui, the chief adviser of Operation Warp Speed says that he expects a COVID-19 vaccine to have efficacy rates in the 90% range. However, he also stated that there might not be enough for all Americans until the end of next year.

Orion Biotechnology Canada received advisory services and conditional funding from the National Research Council Industrial Research Assistance Program to support development of the company’s OB-002, a treatment for COVID-19 acute respiratory distress syndrome (ARDS). The drug is a Chemokine Analog.

 

Company Actions/Announcements

As Moderna launched its Phase III clinical trial of its COVID-19 vaccine this week, a member of the company’s board of directors, Elizabeth “Betsy” Nabel, resigned to avoid any conflict of interest. Nabel is president of Brigham and Women’s Hospital, which is the site of one of the 89 clinical trial sites involved in the Phase III trial.

GlaxoSmithKline and Sanofi struck a $2.1 billion deal with the U.S. government’s Operation Warp Speed program to supply an initial 100 million doses of a COVID-19 vaccine candidate under development by the two companies.

Pfizer and BioNTech announced an agreement with Japan to supply 120 million doses of their COVID-19 vaccine, BNT162.

Alercell announced it reached a $280 million distribution agreement of COVID-19 rapid antibody serology tests with Medigen Biotechnology Corp.

The JEDI (Joint European Disruptive Initiative) Billion Molecules against COVID-19 GrandChallenge, Stage 1, is completed. The challenge was for participating teams to screen one billion molecules and their interactions with COVID-19. An estimated 54 billion molecules were screened by more than 130 teams around the world. The Scientific Committee is currently evaluating the results to determine which team reached the target and wins the 250,000 Euro Prize.

Soomlab in South Korea has developed a unique nanotechnology, thinner than a human hair, that can filter air equal to a medical grade N95 mask. The elite grade mask is the Air Queen Nano Filter Mask and was awarded FDA approval as surgical grade protection in the US. The mask can also be sanitized using isopropyl alcohol and be worn up to 10 times with no significant decrease in ability to filter harmful particles.

 

Other Industry News

As reported by the Wall Street Journal, pharmaceutical companies are in the race against time to develop vaccines but are also having to work to build the supply chains needed to deliver them to billions of people globally.

As reported by Reuters, according to a U.S. security official, Chinese hackers targeted Moderna, who is working on a coronavirus vaccine,  to steal data.

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