Biopharma Update on the Novel Coronavirus: July 6

CV Update_July 6

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

 

FDA Actions

EUA for Detection and Differentiation: The FDA issued a EUA for the third diagnostic test for detection and differentiation of the flu and COVID-19.

Diagnostics Update: To-date the FDA has authorized 162 individual EUAs, which include 136 molecular tests, 25 antibody tests and 1 antigen test.

 

Diagnostics

The FDA approved an emergency use authorization for Becton, Dickinson and Company’s antigen test for coronavirus. The test can be used by medical professionals and can provide results in 15 minutes.

 

Testing Therapies, Antivirals and Vaccines

Regeneron Pharmaceuticals, with the U.S. National Institute of Allergy and Infectious Diseases (NIAID), is launching Phase III trials of REGN-COV2, the company’s two-antibody cocktail for the treatment and prevention of COVID-19.

Companies are competing for healthy volunteers to take part in their COVID-19 trials. According to a Wall Street Journal article, sponsor companies are “taking unusual steps, such as recruiting at pharmacies, enlisting churches in searches for subjects and even requesting employees and families to ask around. Researchers are also rolling out algorithms to target recruitment in places at risk of getting hit with the virus.”

As reported by Reuters, the WHO said on Saturday it is discontinuing trials of malaria drug hydroxychloroquine and combination HIV drug lopinavir/ritonavir in hospitalized patients with COVID-19. The trials did not show a reduced rate of mortality.

Mesoblast Ltd. announced an expanded access protocol (EAP) had been initiated in the U.S. for compassionate use of its allogeneic mesenchymal stem cell (MSC) product, remestemcel-L in children with COVID-19 with cardiovascular and other complications of multisystem inflammatory syndrome (MIS-C). Children between the ages of 2 months and 17 years may receive one or two doses of the therapy within five days of referral.

 

Company Actions

Emergent BioSolutions, based in Gaithersburg, Maryland, entered a five-year manufacturing services deal with Janssen Pharmaceuticals, a Johnson & Johnson company, to manufactures J&J’s Ad26.COV2-S COVID-19 vaccine. Emergent will handle contract development and manufacturing (CDMO) services in a deal that is valued at about $480 million for the first two years.

CytoDyn signed an exclusive Distribution and Supply Agreement with American Regent to distribute leronlimab for COVID-19 in the U.S. The company is currently enrolling a Phase IIb/III trial for 390 severe and critically ill COVID-19 patients. Leronlimab was originally being developed for HIV and for metastatic triple-negative breast cancer. It is a humanized IgG4 monoclonal antibody that blocks CCR5.

As reported by Reuters and the Sunday Times, Britain is close to a $624 million supply deal with Sanofi and GlaxoSmithKline. The deal is for 60 million doses of a potential COVID-19 vaccine.

 

Other Industry News

In a forthcoming paper, “It is Time to Address Airborne Transmission of COVID-19,” 239 scientists from more than 30 countries are pushing the World Health Organization (WHO) to pay more attention to the possible airborne spread of SARS-CoV-2, the novel coronavirus that causes COVID-19.

The Lancet, a medical journal, reported that herd immunity to COVID-19 is unachievable. In a study in Spain, it indicates that just 5% of its population has developed antibodies.

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