Biopharma Update on the Novel Coronavirus: December 15

CV Update_December 15

News information is not all-inclusive and updates are published once a week on Tuesdays. 



The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization to LabCorp’s home test kit for COVID-19, the first testing device that does not require a prescription.

Two recent studies using novel smartphone-based CRISPR technology with both optics and fluorescence detection may help in the detection of SARS-CoV-2 and testing for acute infection.


Testing Therapies, Antivirals and Vaccines

Yesterday was a historic day as the first person in the U.S., ICU nurse Sandra Lindsay, with Long Island Jewish Medical Center in Queens, New York, received the Pfizer-BioNTech COVID-19 vaccine. Now all eyes are turning to Moderna, which has a meeting with the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee on Thursday, December 17. The agency released the data application today.

Eureka Therapeutics' InvisiMask™ Human Antibody Nasal Spray can provide 10 hours of protection from SARS-CoV-2 virus in animal models, according to preclinical results released today. Now it’s heading to clinical trials.

Incyte and Novartis announced a Phase III study of Jakafi (ruxolitinib), a first-in-class JAK1/JAK2 inhibitor, failed to hit endpoints as a treatment for patients 12 and up with COVID-19 associated cytokine storm.

Algernon Pharmaceuticals reported positive trending interim data for the Phase IIb part of the Company’s Phase IIb/III clinical study of Ifenprodil for treatment of COVID-19. The Vancouver-based company reported a trend towards fewer patients requiring mechanical ventilation in the high dose Ifenprodil treatment arm, as compared to patients who were in the untreated arm. Ifenprodil has been generally well tolerated.

Germany’s CureVac announced it has enrolled the first volunteer in the pivotal Phase IIb/III trial of its own mRNA vaccine candidate, CVnCoV against COVID-19.

AstraZeneca, which is jointly developing a COVID-19 vaccine with the University of Oxford, plans to begin clinical trials testing its vaccine in combination with Russia’s Sputnik V vaccine by the end of the year. 

A COVID-19 vaccine being developed by CSL Ltd., and the University of Queensland was scrapped this week after numerous vaccine recipients reported receiving false positives on certain HIV tests. 

The COVID-19 vaccine candidate developed by Sanofi and GlaxoSmithKline hit a snag that will delay the launch of a Phase III study due to an insufficient immune response in older trial patients. The vaccine will now not be available until the end of 2021 – if at all.

Next year could be pivotal for Aridis. It anticipates inflection points for three immunotherapy programs and is making available for licensing its rapid mAb development technology platform, which identifies rare, potent, antibody-producing B cells for therapeutic development. Its COVID-19 therapy is particularly exciting. Please read more here

Two companies make headway on COVID-19 therapeutics. Read more about Cohbar and Sorrento here. 


Organizational Actions/Announcements 

The U.S. Food and Drug Administration (FDA), a day after a positive advisory committee recommendation, granted an Emergency Use Authorization (EUA) to Pfizer and BioNTech for their COVID-19 vaccine. 

The COVID-19 vaccine under development by China’s Sinopharm is showing efficacy of 86%, health authorities from the United Arab Emirates reported.


Other Industry News

After a brutally long year, coronavirus D-Day finally arrived for Americans. As of yesterday morning, regional hubs all across the nation are receiving their super-cooled shipments of Pfizer-BioNTech's coronavirus vaccine, approved for Emergency Use Authorization (EUA) on Friday night. Please read more here

Biogen corporate conference held in February at the Boston Marriott Long Wharf Hotel was initially traced to about 100 cases of COVID-19 that spread across the country. That number has grown exponentially since and researchers now estimate the number of infections linked to the conference could be as many as 300,000.

Viruses mutate, and SARS-CoV-2, the virus that causes COVID-19, is not different. Luckily, it appears to mutate relatively slowly. Meanwhile, researchers are beginning to get a grip on the virus’s evolution. Please read more here

Documents related to the COVID-19 vaccine developed by Pfizer and BioNTech that were in possession of the European Medicines Agency have been accessed by hackers.

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