Biopharma Update on the Novel Coronavirus: June 10

CV Update_June 10

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


FDA Actions

Temporary Policy on Prescription Drug Marketing Act Requirements: The FDA issued guidance addressing questions concerning prescription drug sample distribution under the Prescription Drug Marketing Act of 1987 (PDMA) during the COVID-19 pandemic.

Ventilators: The FDA added the BioMedInnovations SuppleVent Ventilator to the list of authorized ventilators.

Warning Letter: The FDA issued a warning letter to for selling fraudulent COVID-19 products.

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, 128 individual EUAs have been issued, which includes 108 molecular tests, 19 antibody tests and 1 antigen test.



Illumina indicated the U.S. Food and Drug Administration (FDA) issued an EUA for the Illumina COVIDSeq™ Test, a sequencing-based, in vitro diagnostic (IVD) workflow for the detection of SARS-CoV-2.

Avacta Group announced a BAMS (bead-assisted mass spectrometry) diagnostic test for the COVID-19 infection, being developed with its partner Adeptrix, an detect the coronavirus spike protein in model samples in the concentration range appropriate for a clinical diagnostic test. The BAMS assay uses the Affimer reagents specific to the SARS-COV-2 virus to capture the virus spike protein from the sample for rapid detection by mass spectrometry.

Dark Daily, a firm focused on clinical diagnostics, published an article discussing how the COVID-19 pandemic is affecting clinical laboratory specimen transportation. Some of the challenges include limited officer hours, closed physician practices, and requiring couriers to check for symptoms on healthcare campuses.

Vermillion’s wholly-owned subsidiary ASPIRA Labs completed laboratory validation of the Roche Elecsys Anti-SARS-CoV-2 antibody test for antibodies against COVID-19. The test and other biomarkers will be used on the ASPIRA pelvic mass assessment pre-surgery workup.


Testing Therapies, Antivirals and Vaccines

In an interview this morning with CNN, Dr. Anthony Fauci said the government will help finance Phase III studies of three COVID-19 vaccine candidates. The vaccine candidates that the government will subsidize the late-stage trial are under development by Moderna, AstraZeneca and the Jenner Institute of Oxford, and Johnson & Johnson

Past vaccine failures may reduce COVID-19 vaccination rates. With more than 130 COVID-19 vaccines in development around the world, many of them are bound to fail. When they do, will that erode the public trust in the vaccines that are approved? The answer largely depends on where in the development cycle the vaccines fail and the scope of their failure.

Fulcrum Therapeutics announced it has submitted an investigational new drug (IND) application to evaluate losmapimod as a potential treatment for patients with COVID-19. Fulcrum is preparing to start a Phase III trial. Losmapimod is a p38 inhibitor currently being studied in a Phase 2b clinical trial in patients with facioscapulohumeral muscular dystrophy. Inhibition of the p38 MAPK pathway may play a role in treating COVID-19-related symptoms.

IGY Life Sciences and MMS Holdings will collaborate to advance the development of IgY-110, an anti-CoV-2 therapeutic antibody with a focus on a nasal spray application. This novel approach of an IgY antibody in a nasal spray will be complementary to any vaccine developed, the companies said. The nasal spray therapeutic is intended to treat those currently infected with COVID-19 by controlling and blocking the spread of coronavirus.

India’s Panacea Biotech and Refana Inc. USA forged an agreement to develop a COVID-19 vaccine.

Tychan announced it is initiating Phase I clinical trials to evaluate TY027, a novel monoclonal antibody (mAb) that specifically targets SARS-CoV-2. The trial is expected to take only about six weeks.

Kalytera Therapeutics announced proof-of-concept data for R-107, its liquid nitric oxide donor, to treat pulmonary arterial hypertension (PAH) in COVID-19 patients with acute respiratory distress syndrome (ARDS).

Eli Lilly launched a Phase I study of its second COVID-19 antibody treatment with partner Junshi Biosciences. The antibody, JS016 is the company’s second neutralizing antibody to begin trials, following LY-CoV555.


Other Industry News

The novel coronavirus that has swept across the globe over the past few months infecting millions of people remains a mystery in many ways due to the complexity of the disease. That was the sentiment expressed by Dr. Anthony Fauci, the director of the National Institute of Allergy & Infectious Diseases (NIAID), during a one-on-one interview with Michelle McMurry-Heath, the new chief executive officer of Biotechnology Innovation Organization (BIO)

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