Biopharma Update on the Novel Coronavirus: April 30

CV Update_April 30

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FDA Actions

Sellers Who Place Profits Above the Public Health: With support from the FDA’s Office of Criminal Investigations and Office of Chief Counsel, the U.S. DOJ announced a federal court in Utah entered an injunction halting the sale of various products, promoted as treatments for COVID-19. The FDA issued a statement that they will are committed to working with the U.S. DOJ to take appropriate action against those who are jeopardizing Americans’ health.

New Dosing Regimen for Cancer: The FDA granted accelerated approval for cancer therapy for the dosing regiment which allows patients with certain cancers to continue treatment with fewer in-person visits.

EUA for SARS-CoV-2 Antibody Tests: The FDA issued an Emergency Use Authorization (EUA) for SARS-CoV-2 Antibody Tests that have been evaluated in an independent validation study performed at the National Institutes of Health’s (NIH) National Cancer Institute (NCI), or by another government agency designated by FDA, and are confirmed by FDA to meet the criteria set forth in the Scope of Authorization.

FAQs: The FDA posted FAQs on ventilators addressing the Enforcement Policy on Ventilators and Ventilators added to the “umbrella” EUA and also FAQs on EUAs for Medical Devices During the COVID-19 Pandemic.

Diagnostics Update: The FDA has worked with more than 380 test developers who plan to submit EUA requests to detect COVID-19. Also, 50 individual EUAs have been issued. In addition, 23 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs). The FDA has been notified that more than 235 laboratories have begun testing under the policies set forth in its COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.



A research team is exploring the use of sugar chains in human cells as a potential test for the presence of COVID-19. The test, developed by a team at the University of Manchester, could be used at home and provide a quick diagnosis of an ailment as coronavirus or the flu. The team hopes to have the test available by the fall.

Alevo Technologies announced it has partnered with Janssen Pharmaceuticals, a company of Johnson & Johnson, to advance Alveo’s be.well™ platform of analyzers, nasal swabs and cartridges for the detection of viral infectious diseases, including Respiratory Syncytial Virus (RSV) and potentially SARS-CoV-2.


Testing Therapies, Antivirals and Vaccines

The U.S. National Institute of Allergy & Infectious Diseases (NIAID) reported that its clinical trial of Gilead Sciences’ remdesivir in 1,063 COVID-19 patients met its primary endpoint. Patients receiving the drug recovered faster than similar patients who received placebo. The trial was known as the Adaptive COVID-19 Treatment Trial (ACTT).

AstraZeneca and the University of Oxford have partnered on the global development and distribution of Oxford’s COVID-19 vaccine it is developing. The university’s Jenner Institute and Oxford Vaccine Group are expecting to launch a clinical trial of more than 6,000 people in May, showing not only that their COVID-19 vaccine is safe—typically the goal of smaller Phase I clinical trials—but effective, the goal of larger Phase II and Phase III clinical trials. With emergency approval, the Oxford University researchers believe they could have a few million doses of the vaccine available by September if it is proven effective.

Companies Altreca, BeiGene and IGM Biosciences announced plans to collaborate leveraging their technology and expertise to discover, develop, and manufacture novel IgM and IgA antibodies targeting SARS-CoV-2 for the potential treatment of COVID-19.

San Diego-based Personalized Stem Cells Incorporated is seeking emergency approval from the FDA for an experimental trial of stem cell therapy for coronavirus patients.

ILC Therapeutics, based in the U.K., is seeking financing to accelerate two COVID-19 studies, which the company believes could be used to prevent Acute Respiratory Distress Syndrome (ARDS). The company, according to reports, has patented a new Interferon-Alpha subtype, called Interferon Alpha 14, which can be administered to patients through injection or inhalation and used to treat the disease.N.C.-based Heat Biologics is developing a vaccine that will clear virus infected cells and promote long-term cellular immunity to prevent re-infection in high-risk patients. The company is using its gp96 platform to develop the vaccine candidate.

U.K.-based- Stabilitech Biopharma Ltd. is seeking £6m to help develop OraPro-COVID-19, the company’s oral vaccine for COVID-19. OraPro-COVID-19 provides double immunity, targeting both systemic and mucosal immunity, the company said.


Company Actions

FUJIFILM Diosynth Biotechnologies announced that it will reserve manufacturing capacity for a future COVID-19 therapy for the COVID-19 Therapeutics Accelerator. The Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation and others to speed-up the response to the global pandemic. The Therapeutics Accelerator is working to accelerate drug development and will identify a promising COVID-19 therapeutic candidate.

HudsonAlpha Institute of Biotechnology teamed with iRepertoire, an Alabama diagnostic technology company, to study local patients who have been diagnosed with COVID-19 to develop a treatment. The team will assess the blood of patients to find antibodies that could lead to treatments and a possible vaccine.


Other Industry News

Faster drug development processes are likely to outlive COVID-19. The COVID-19 pandemic has increased the pace of drug development and regulatory approval dramatically, accelerating activities in ways that shorten the time needed to deliver safe, effective therapeutics, vaccines and diagnostics to patients.

BioSpace spoke to Aurika Savickaite, RN, MSN, to learn more about the Helmet Based Ventilator initiative, NIV helmets and how they can be used during this coronavirus pandemic.

Disgraced pharmaceutical executive Martin Shkreli wants out of prison to help research a treatment for COVID-19, but federal prosecutors want him to remain behind bars for the duration of his sentence for fraud.

A Seattle-based pharma entrepreneur is in hot water over unauthorized sales of a concoction he billed as a COVID-19 vaccine. Johnny Stine, head of North Coast Biologics, was issued a cease-and-desist letter from Washington’s attorney general for making “false or unsupported claims’’ about a coronavirus “spike protein vaccine” that doesn’t yet exist, the Seattle Times reported. Stine was selling the concoction for $400.

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