Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 10, 2020.
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 organic-beauty-recipes.com 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.
Diagnostics
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)
.