Biopharma Update on the Novel Coronavirus: June 3

CV_Update_June 3

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FDA Actions

New Guidance: The FDA issued the guidance, Institutional Review Board (IBB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators.

Second Ventilator Developed by NASA: The FDA issued a EUA for another ventilator developed by NASA. The NASA VITAL (Ventilator Intervention Technology Accessible Locally) is tailored to provide respiratory support for COVID-19 patients experiencing respiratory failure or insufficiency and intended to last three to four months.

Emergency Resuscitator: The FDA issued a EUA for the Fitbit Flow, an emergency resuscitator. The design is intended for use in treating COVID-19 patients and is a continuous respiratory support system that includes an FDA-cleared Manual Resuscitator.

Pediatric Product Development Plans: The FDA and the European Medicines Agency (EMA), provided procedural assistance to sponsors and applicants anticipating to submit pediatric product development plans for the treatment and prevention of COVID-19.

Diagnostics Update: The FDA has worked with more than 400 test developers who have submitted or plan to submit EUA requests to detect COVID-19. Also, 119 individual EUAs have been issued, which includes 103 molecular tests, 15 antibody tests and 1 antigen test.


Testing Therapies, Antivirals and Vaccines

Cambridge, Massachusetts-based Moderna is largely ahead of the game in the U.S. for developing a vaccine against COVID-19. On May 20, the company released positive interim Phase I data from its clinical trial of mRNA-1273. Yesterday, Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), which is collaborating on the vaccine with Moderna, told the editor of the technical journal JAMA that the vaccine’s Phase III trial is expected to launch in July. It will evaluate 30,000 patients ranging in age as 18 years and include the elderly.

As reported by CNBC, during an interview Tuesday evening with JAMA Editor Howard Bauchner, White House health advisor Dr. Anthony Fauci worries about the “durability” of a potential coronavirus vaccine.

FSD Pharma Inc. announced the FDA has given it permission to submit an Investigational New Drug Application (IND) for the use of its product FSD-201 to treat COVID-19. FSD Pharma will design a Phase IIa clinical trial. The company is developing FSD-201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in COVID-19.

CDMO company AGC Biologics will partner with Novavax on large-scale GMP production of a critical component of Novavax’ coronavirus vaccine candidate, NVX-CoV2373. AGC Biologics will manufacture Matrix-M, the adjuvant component of the vaccine, in order to enhance the immune response and stimulate high levels of neutralizing antibodies.

As reported by Reuters, the UK is conducting trials of a unique formulation of ibuprofen to see if it reduces respiratory failure in patients with severe COVID-19 symptoms.


Company Actions

Laboratory Corporation of America, or LabCorp, is one of the two largest clinical diagnostic laboratory companies in the U.S. The company announced its Covance drug development business was launching COVID-19 Clinical Trial Connect in the U.S. to help people find information on taking part in clinical trials related to COVID-19.


Other Industry News

Industry experts say a vaccine against the SARS-CoV-2 virus will either be ready this fall, at the end of the year or 18 months from now, depending on the vaccine and how they define “ready.”

A little more than six months have passed since the novel coronavirus that has swept across the globe and infected more than 6 million people first reared its head in China. Since that time, researchers have been learning as much about the disease as possible in order to accurately diagnose it and develop effective treatments. In its ongoing examination of COVID-19 related research, the journal Nature has provided updates on several scientific papers assessing diagnostics related to the detection of the virus as well as questions surrounding antibody testing and the likely way the virus enters the body.

As reported by Science Daily, a study conducted in Sydney, Australia and published in Transboundary and Emerging Diseases found an association between lower humidity and an increase in locally acquired positive COVID-19 cases. The research led by Professor Michael Ward from the University of Sydney and two researchers from partner institution Fudan University discovered that a 1% decrease in humidity could increase the number of COVID-19 cases by 6%.

NBC News reported that some COVID-19 testing sites have suspended operations as the result of violence and protests related to the death of George Floyd, who was killed in Minneapolis by police officers. The mentioned sites that have temporarily suspended operations are in Florida and California.

The World Health Organization and public health officials are grappling with the problem of determining asymptomatic COVID-19 patients versus pre-symptomatic patients. A China study suggested that 300 symptomless carriers of SARS-CoV-2 were not infectious. This appears to be different than people who are pre-symptomatic, and because of the incubation period and variation in symptoms, carriers can infect other people during this period. The WHO believes that pre-symptomatic carriers are infectious and say there is a possibility that asymptomatic carriers may also transmit the virus, although there is not much evidence of that yet.


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