Biopharma Update on the Novel Coronavirus: July 24
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
FDA Actions
Warning Letter: The FDA and the FTC issued a joint warning letter to 21st Century LaserMed Pain & Regenerative Medicine Institute (d/b/a Create Wellness Clinics) for offering fraudulent COVID-19 products.
FDA Issued Updates for the Following:
New Website Section: The FDA created a new website about COVID-19 for people with cancer and health care professionals to highlight resources.
Diagnostics Update: To-date the FDA has authorized 187 individual EUAs, which include 154 molecular tests, 31 antibody tests and 2 antigen tests.
Testing Therapies, Antivirals and Vaccines
An antiviral drug developed by Glenmark Pharmaceuticals boosted the time it takes COVID-19 patients with mild to moderate symptoms to improve their health in a Phase III study.
A big week for COVID-19 vaccine trials. Three of the most advanced COVID-19 vaccines published data from early and mid-range clinical trials this week.
Researchers at Rensselaer Polytechnic Institute published results in Nature’s Cell Discovery showing that an extract of edible seaweeds – compounds called fucoidins - outperforms the standard COVID-19 antiviral remdesivir in blocking SARS-CoV-2 infection in mammalian cells. Heparin, a common blood thinner with a related sulfated polysaccharide structure, performed on par with remdesivir in the same test. Both compounds show promise as therapeutics for blocking infection -- one perhaps in a dietary supplement, the other as a nasal spray.
Many clinics in the U.S. are getting prepared to take part in Moderna’s Phase III clinical trial for their COVID-19 vaccine. The trial will take place at 87 sites across 30 states and Washington D.C.
Researchers in Brazil published a study in The New England Journal of Medicine finding that hydroxychloroquine, alone or with antibiotic azithromycin, did not help hospitalized patients with mild-to-moderate COVID-19.
Company Actions
The National Institutes of Health (NIH) announced plans to launch a “flurry” of large-scale clinical trials for treating COVID-19. The studies include a laundry list of approaches, including monoclonal antibodies against the virus SARS-CoV-2 in hospitalized patients as well as patients who can receive treatment at home; drugs focused on tamping down the cytokine storm caused by an overreaction of the immune system; blood thinners to prevent issues associated with blood clots; and vaccines, including the one under development by Moderna.
Novavax and FUJIFILM Diosynth Biotechnologies announced an agreement to manufacture bulk drug substances for NVX-CoV2373, Novavax' COVID-19 vaccine candidate. FDB's site in Morrisville, North Carolina has begun production of the first batch of NVX-CoV2373. This arrangement falls under Novavax' recent $1.6 billion award by the federal government as part of Operation Warp Speed.
Arcturus Therapeutics, Inc. announced a deal with the government of Israel to supply the Israeli Ministry of Health with the company’s COVID-19 vaccine candidate, LUNAR-COV19. Arcturus continues to scale up manufacturing to potentially produce hundreds of millions of doses across 2020 and 2021.
Cambridge, Mass.-based Centogene announced that its validated COVID-19 test kit, called CentoKit-19, is now available in Germany on Amazon.de. CENTOGENE is the first provider worldwide to makes its innovative and comprehensive testing solution for the detection of SARS-CoV-2 virus RNA available to all individuals in Germany via the online marketplace.
The UK government invested $125 million in its new Cell and Gene Therapy Catapult Manufacturing Innovation Centre, which will begin manufacturing COVID-19 vaccines at scale by the end of 2021. This was on top of a £93 million investment in the Vaccines Manufacturing and Innovations Centre. The new investment was largely to ensure the center was prepared for future pandemics. An additional £38 million was for a “rapid deployment” facility to get new vaccines out to the public as quickly as possible.
Researcher in Brazil published a study in The New England Journal of Medicine finding that hydroxychloroquine, alone or with antibiotic azithromycin, did not help hospitalized patients with mild-to-moderate COVID-19. The study out of Brazil evaluated 667 patients, 504 who had confirmed COVID-19 and were included in a modified intention-to-treat analysis. It was conducted at 55 hospitals in Brazil.
CEL-SCI Corporation concluded animal experiments using its LEAPS COVID-19 conjugate, which supported moving forward into animal challenge studies with live SARS-COV-2 virus. The conjugate induced faster and much higher than expected antibody responses against a non-mutating region of the virus after only one injection.
Other Industry News
After the U.S. Department of Health and Human Services (HHS) and the Department of Defense’s Operation Warp Speed program cut a $1.95 billion deal with Pfizer and BioNTech for production of their experimental COVID-19 vaccines, President Donald Trump referred to it as “a historic agreement.”