Pharma COVID Roundup: News from Bausch, Inovio, and the FDA

The latest on manufacturing and potential treatments for COVID-19 with news from Bausch Health, Inovio, the FDA, Bharat Biotech, and the Medicines Patent Pool.

Manufacturing and supply of COVID-19 vaccines and drugs

Generics Companies in Pact with UN-Backed Nonprofit for COVID Drugs
A group of 18 generic companies have pledged to work with the Medicines Patent Pool (MPP), a Geneva, Switzerland-based nonprofit organization, to accelerate access to COVID-19 treatments to low- and middle-income countries.

Collectively the 18 companies joining the pledge have the capacity to deliver small-molecule drugs and biologics, including monoclonal antibodies, for targeting COVID-19.

The companies joining the effort are connected by their past work with MPP, an organization created in 2010 by the global health initiative UNITAID, a global health organization focused on the prevention and treatment of major diseases in low- and middle-income countries, to negotiate patent license agreements with pharmaceutical companies to make them more easily accessible for generics manufacturers.

Source: Medicines Patent Pool

Updates on COVID-19 treatments and vaccines

Bharat Biotech Starts Phase III Trials for COVID-19 Vaccine
Bharat Biotech, a Hyderabad, India-based biopharmaceutical company, has initiated Phase III clinical trials for its COVID-19 vaccine candidate, Covaxin.

The Phase III trials will involve 26,000 volunteers across India and will be conducted in partnership with the Indian Council of Medical Research. The company says Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials and showed promising safety and immunogenicity data.

Bharat Biotech developed Covaxin in collaboration with the Indian Council of Medical Research at the National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated at the NIV in Pune, India and transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s facility in Hyderabad, India.

Source: Bharat Biotech

Inovio Gets FDA OK for Phase II Trial of COVID-19 Vaccine
Inovio, a Plymouth Meeting, Pennsylvania-based biopharmaceutical company developing DNA-based immunotherapies for cancer and infectious diseases, has received clearance from the US Food & Drug Administration (FDA) to proceed with the Phase II segment of its planned Phase II/III clinical trial for INO-4800, its COVID-19 vaccine candidate.

The trial will be funded by the US Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense in coordination with the Office of the Assistant Secretary of Defense for Health Affairs and the Defense Health Agency.

The Phase II segment of the trial is designed to evaluate INO-4800 in a two-dose regimen. The Phase III segment of the trial remains on partial clinical hold until Inovio resolves questions by the FDA related to the Cellectra 2000 device that will be used to deliver INO-4800 directly into the skin. The company says it plans to resolve the remaining device questions during the conduct of the Phase II segment and prior to the start of the Phase III segment of the trial.

The Phase II segment of the trial is expected to enroll approximately 400 participants at up to 17 US sites in order to confirm the dose(s) for the subsequent efficacy evaluation planned for the Phase III segment.

The DoD has agreed to provide funding for both the Phase II and Phase III segments of the clinical trial in addition to the $71 million of funding previously announced in June (June 2020) for the large-scale manufacture of the company’s proprietary smart device, Cellectra 3PSP, and the procurement of Cellectra 2000 devices.

Source: Inovio

Bausch Reports Data for Eye Drops Used in COVID-19 Treatments
Bausch Health and Bausch + Lomb, its global eye-health business, report investigational in vitro data showing that two benzalkonium chloride (BAK)-preserved eye drops indicated complete inactivation of SARS-CoV-2, the virus that causes COVID-19.

In the study, researchers evaluated the in vitro antiviral activity of Lumify (brimonidine tartrate ophthalmic solution 0.025%), used to relieve redness in eyes, and Besivance (besifloxacin ophthalmic suspension 0.6%), used to treat pink eye, against SARS-CoV-2 using a Vero E-6 host-cell system. Both Lumify and Besivance contain 0.01% BAK, a quaternary ammonium compound commonly used as a preservative in ophthalmic topical solutions. The company says the activity of BAK against SARS-CoV-2 is not well understood.

The company says that the results indicated complete inactivation of the SARS-CoV-2 virus at all contact times. Neither Lumify nor Besivance have been proven to prevent or treat COVID-19 in humans nor have they been approved for those uses by the US Food and Drug Administration.

Source: Bausch Health

FDA Updates Guidance on COVID-19 Convalescent Plasma
The US Food and Drug Administration has updated its guidance on convalescent plasma as an investigational treatment for COVID-19, 

The use of convalescent plasma is an investigational treatment for COVID-19 where convalescent plasma is collected from individuals who have recovered from COVID-19 and contains antibodies to SARS-CoV-2, the virus that causes COVID-19.

The updated guidance extends the period of enforcement discretion through the end of February 2021. This extension will allow continued access to convalescent plasma for the treatment of hospitalized COVID-19 patients while blood establishments develop operating procedures to manufacture the plasma consistent with the emergency use authorization.

The guidance also includes a new recommendation that authorized COVID-19 convalescent plasma not be collected from individuals who have received an investigational COVID-19 vaccine.

Source: US Food and Drug Administration (announcement of update) and US Food and Drug Administration (guidance)

News on COVID-19 testing

FDA OKs First COVID-19 At-Home Self-Test
The US Food and Drug Administration has issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home.

The Lucira COVID-19 All-In-One Test Kit, developed by Lucira Health, an Emeryville, California-based company, is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect SARS-CoV-2, the virus that causes COVID-19.

The test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19. It is also authorized for use in point-of-care settings for all ages. The test is currently authorized for prescription use only.

Source: US Food and Drug Administration

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