Biopharma Industry News for March 19: Update on the Novel Coronavirus

Coronavirus update

Please stay tuned for more updates throughout the day. 

 

FDA Actions

The FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic, released Wednesday, are “a really good first step in ensuring that clinical trials continue with minimum disruption,” according to Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP). As the guidance says, the Food and Drug Administration (FDA) recognizes that the COVID-19 pandemic may affect the conduct of clinical trials.

 

Diagnostics

Abbott: The U.S. Food and Drug Administration (FDA) approved Abbott’s molecular test for the novel coronavirus that causes COVID-19 under an Emergency Use Authorization (EUA). The company indicates it is immediately shipping 150,000 Abbott RealTime SARS-CoV-2 EUA tests to current customers in the U.S. The company is scaling up production to reach capacity for 1 million tests per week by the end of March. 

Biomerica: Biomerica stated it has started to ship initial samples of a finger prick blood test for COVID-19 to countries outside the U.S. According to Biomerica, results take only 10 minutes.

American Clinical Lab Association: ACLA President, Julie Khani sent a letter seeking support from the federal government. ACLA has asked Congress for an emergency laboratory surge capacity fund of $5 billion to help meet the demand for testing COVID-19. 

 

Testing Therapies, Antivirals and Vaccines

Roivant: Roivant has announced the development of Gimsilumab to prevent and treat acute respiratory distress syndrome (ARDS) in patients with COVID-19. A Phase I study of the treatment has been associated with a favorable safety and tolerability profile to date.

Roche: Following reports of successful treatment in China, Roche is launching a Phase III trial of its RA drug Actemra as a treatment for COVID-19 pneumonia. The drug has become a recommended treatment for patients with this indication in China.

Generex Biotechnology: Generex provided guidance on their work to develop a peptide vaccine against the novel coronavirus. Generex's li-Key peptide vaccines have been studied for infectious disease in Phase I and Phase II clinical trials in over 300 subjects. 

FUJIFILM: Chinese researchers say a flu drug approved for use in Japan is proving effective in treating patients with the novel coronavirus.

Nascent Biotech has begun in vitro research on pritumumab as a potential treatment for COVID-19. The asset's specific target, cell surface vimentin, is a potential target in the treatment of conditions related to COVID-19, the company said.

Gilead Sciences has two Phase III clinical trials ongoing in the U.S. of its investigational antiviral drug remdesivir in adults diagnosed with COVID-19, the disease caused by the novel coronavirus. These trials are on top of two clinical trials in China’s Hubei province. The China trial data is expected in April. Early indicators suggest that the drug could be approved for COVID-19 very soon, according to a Piper Sandler analyst.

Bayer: Bayer plans to donate 3 million tablets of an older malaria drug to the U.S. government as a possible treatment for COVID-19 patients. Bayer's antimalarial drug, chloroquine, is relatively inexpensive, but more testing needs to be done. 

 

Company Actions

Pfizer: Pfizer postpones its Investor Day conference set for March 31 due to concerns over COVID-19. The company plans to reschedule the event but has not yet determined a date to do so, due to the ongoing pandemic. 

Eli Lilly: Eli Lilly is teaming up with the Indiana State Department of Health to accelerate testing for COVID-19. 

 

Other Industry News

Pandemic COVID-19 vs. H1N1 influenza pandemic of 2009: The world is currently experiencing a global pandemic of SARS-CoV-2, the novel coronavirus that causes COVID-19. As of March 17, 2020, hundreds of thousands of people have been confirmed to have been infected. It may be instructional to look at the last major pandemic, the H1N1 influenza pandemic of 2009. 

World's Most Powerful Supercomputer: IBM-built Summit, the world’s most powerful supercomputer, is being used to help identify drugs to treat COVID-19. In February, the computer was used to screen 8,000 known drug compounds to identify the ones most likely to be effective against the virus. They then narrowed it down to 77 in only two days.

The pharmaceutical industry is banding together to combat the novel coronavirus. Companies vowed to “be one team” to work toward a solution for the pandemic, Pfizer Chief Scientific Officer Mikael Dolsten said. In an industrywide conference call, company leaders highlighted their vaccine and treatment programs for COVID-19.

 

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