Biopharma Update on the Novel Coronavirus: June 5
News information is not all-inclusive. Please check back for updates.
FDA Actions
ANDA: The FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection. This is indicated for sedation of initially intubated and mechanically ventilated patients. This drug is listed in the FDA Drug Shortage Database.
Warning Letters: The FDA issued warning letters to operators of four websites that market unapproved and misbranded COVID-19 products. The websites include: www.roidsmall.net, www.emedkit.com, www.4nrx.md and www.chloroquineonline.com
Letter to Clinical Laboratory Staff and Health Care Providers: The FDA issued a letter about a safety risk with using transport media and COVID-19 testing platforms that are not compatible.
Test Performance Data: The FDA posted test performance data from four additional antibody/serology test kits.
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, 120 individual EUAs have been issued, which includes 104 molecular tests, 15 antibody tests and 1 antigen test.
Testing Therapies, Antivirals and Vaccines
Novavax has received $60 million in funding from the U.S. Department of Defense (DoD) to manufacture its COVID-19 vaccine candidate. The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CRBND-EB), with funding from the Defense Health Program, is supporting Novavax’s manufacture of several components of the vaccine in the U.S.
AbbVie, Harbour BioMed, Utrecht University and Erasmus Medical Center announced they have entered into a collaboration. The collaboration is to develop a novel antibody therapeutic to prevent and treat COVID-19. The focus will be to advance the fully human, neutralizing antibody 47D11.
iBio, Inc. announced the initiation of preclinical immunization studies for its second COVID-19 vaccine platform. The new subunit vaccine, IBIO-201, combines antigens derived from the SARS-CoV-2 spike protein fused with the company’s patented lichenase booster molecule, which is designed to enhance the immune response. The addition of the LicKM booster to a subunit antigen is expected to improve the likelihood of achieving single-dose, prolonged immunity while also increasing manufacturing capacity through increased potency.
Algernon Pharmaceuticals received FDA clearance for a Phase IIb/III study of its re-purposed drug NP-120 (Ifenprodil) as a potential therapeutic treatment for patients with COVID-19. Ifenprodil is an NMDA receptor antagonist.
BioSig Technologies and its subsidiary, ViralClear Pharmaceuticals announced it has expanded its patient enrollment centers to include St. David’s South Austin Medical Center. BioSig intends to commence its Phase II clinical trial for an oral anti-viral candidate for COVID-19. For more information on the trial and the candidate, please read, Startup ViralClear Drives Antiviral into Phase II for COVID-19 Following Significant Preclinical Results.
Company Actions
Because of the issues with the CMO, Korea-based VGXI, Inc., Inovio has filed a lawsuit seeking to break the impasse and transfer an existing supply agreement to another agency. VGXI, according to the company’s lawsuit, is unable or unwilling to manufacture its COVID-19 vaccine candidate in large quantities.
Moderna hired a new CFO, as it ramps up to launch commercial operations and to deal with potential significant growth if it releases a successful COVID-19 vaccine.
UK-based AstraZeneca and the University of Oxford have partnered on the global development and distribution of Oxford’s COVID-19 vaccine, AZD1222. The company announced plans to manufacture two billion doses of the vaccine, with 400 million allotted for the U.S. and UK and one billion for low- and middle-income countries.
Other Industry News
As reported by CNBC, according to an analysis of data compiled by Johns Hopkins University, cased in the U.S. have been on a gradual rise since Memorial Day weekend. On Wednesday, there was an all-time high of 130,400 new cases confirmed around the world.