Biopharma Update on the Novel Coronavirus: May 12

CV Update_May 12

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FDA Actions

New Actions to Accelerate Prevention and Treatment Options for COVID-19: The FDA provided new guidance for innovators and researchers conducting work on COVID-19. The guidance was issued with the goal to make the process for submitting applications more efficient and outlines ways to design clinical trials to evaluate safety and efficacy.

EUA: The FDA issued a EUA for Fresenius Propoven 2% Emulsion to sedation via continuous infusion for patients older than 16 who require mechanical ventilation during the pandemic.

Warning Letters: The FDA and FTC issued warning letters to Seanjari Preeti Womb Healing, L.L.C. and Plum Dragon Herbs, Inc. for selling fraudulent COVID-19 products. To date, there have been 46 COVID-19 related warning letters.

Conduct of Clinical Trials of Medical Products During COVID-19: The FDA added content to the Q&A appendix in its guidance. The updated content includes information on considerations for using alternative labs or imaging centers, holding trial participant visits via video conference, conducting required post-marketing clinical trials and more.

Abbreviated New Drug Applications: The FDA approved ANDAs for cisatracurium besylate injection USP 20 mg/10 mL and azithromycin tablets USP, 600 mg. Both ANDAs are relevant to COVID-19 as both medicines are listed in the FDA Drug Shortage Database.

Policy for Coronavirus Disease-2019 Tests: The FDA updated this policy and includes EUA submission templates for molecular, antigen and serology tests.

Surveillance Inspections: The FDA released a statement indicating it will continue to utilize and implement alternative inspection tools and approaches as they postpone domestic and foreign routine surveillance inspections. This will continue as needed.

Diagnostics Update: The FDA has worked with more than 385 test developers who plan to submit EUA requests to detect COVID-19. Also, 92 individual EUAs have been issued, which includes 12 antibody tests and 1 antigen test. The FDA has been notified that more than 245 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.



ProMIS Neurosciences identified 18 potential antibody targets unique to the spike protein halo of SARS CoV-2, which will be synthesized over the coming weeks as a high-throughput antibody test. The synthesis will occur in the serology lab of Hans Frykman at the University of British Columbia.


Testing Therapies, Antivirals and Vaccines

CEPI awarded an additional $384 million in grant money to Maryland-based Novavax to advance the development and manufacturing of that company's COVID-19 vaccine candidate. A Phase I study is expected to begin this month in Australia and a global Phase II trial is planned for July. 

The Food and Drug Administration (FDA) granted Moderna, Inc.'s mRNA vaccine candidate against COVID-19 Fast Track Designation. The designation will expedite regulatory review of the vaccine that recently entered Phase II development. Moderna is finalizing the protocol for a Phase III study, expected to begin in early summer of 2020. 

Switzerland-based Neovii Pharmaceuticals AG and Tel Aviv University's technology transfer company RAMOT, will work in collaboration to develop a COVID-19 vaccine. The collaboration focuses on the development of a first-in-class COVID-19 vaccine that targets the Achilles' heel of the virus by reconstructing the coronavirus's Receptor Binding Motif (RBM), a critical structure of its spike protein. 


Company Actions

Nascent Biotech entered into a research collaboration agreement with Manhattan BioSolutions to initiate a COVID-19 vaccine program. The program will augment Nascent’s current development plans to investigate pritumumab for COVID-19. Manhattan’s platform is based on the recombinant Mycobacterium Bovis Bacillus Calmette-Guerin (rBCG), a genetically engineered vaccine to express selected SARS-CoV-2 proteins. BCG is a live non-pathogenic bacterium that has been used as a tuberculosis vaccine.


Other Industry News

As reported by CNBC, Dr. Scott Gottlieb said Alabama, South Dakota and Texas have already begun to see an increase in confirmed COVID-19 cases since they’ve eased coronavirus restrictions.

Mylan CEO Heather Bresch said the pharmaceutical company’s global medical supply chain has experienced minimal disruption during the COVID-19 pandemic, according to CNBC.

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