Biopharma Update on the Novel Coronavirus: June 19
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
Statistical Considerations for Clinical Trials: The FDA published guidance that provides recommendations on statistical considerations to address the impact of COVID-19 to meet the objectives of clinical trials.
Warning Letters: The FDA issued warning letters to Medakit, Ltd., of Sheung Wan, Hong Kong, Antibodiescheck.com and Yama Group and Sonrisa Family Dental d/ba My COVID10 Club for marketing COVID-19 tests adulterated and misbranded COVID-19 antibody tests.
EUA for Medical Devices: The FDA has a new web section that provides information for EUAs for medical devices during the COVID-19 pandemic.
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, 141 individual EUAs have been issued, which include 120 molecular tests, 20 antibody tests and 1 antigen test.
As reported by The New York Times and the Business Journal, Verily Life Sciences announced Thursday, it is introducing a health screening and analytics service for businesses. The service will provide COVID-19 diagnostic testing for employees to help clear them to return to the workplace.
Testing Therapies, Antivirals and Vaccines
Aethlon Medical announced it received the FDA’s approval to test a blood-filtering medical device, Hemopurifier to remove the virus from COVID-19 patients.
UV-C light has been used as a disinfectant against viruses and bacteria for more than 40 years. Now, researchers at Boston University and Signify (formerly Phillips) have confirmed that it also effectively eradicates the SARS-CoV-2 virus.
Sinovac said it could finish it’s Phase III trial, the last phase trial, of its COVID-19 vaccine candidate as early as this fall as reported by ABC News.
On Wednesday, Gilead announced it planned to soon start enrolling an open-label, single-arm Phase II/III clinical trial of remdesivir in about 50 pediatric patients with moderate-to-severe COVID-19, including newborns through adolescents. The trial will be performed at more than 30 locations in the U.S. and Europe.
The World Health Organization (WHO) has said in a statement on Wednesday that the recent results "showed that hydroxychloroquine does not result in the reduction of mortality of hospitalized COVID-19 patients." The WHO halted research to evaluate whether hydroxychloroquine is an effective treatment for COVID-19.
As reported by Reuters, Roche’s RA drug Actemra failed in an Italian study to help patients with early-state COVID-19 pneumonia. The company will continue with another trial for COVID-19 despite the setback.
The Co-Immunity Project announced results from its Phase I of its testing to track and curb the spread of SARS-CoV-2. The project is a collaboration between the University of Louisville (Kentucky) and the Louisville Healthcare CEO Council. The Phase I tested health care workers in Louisville. The bottom line was that precautionary measures worked in preventing the disease’s transmission among health care workers.
Veru enrolled the first patient in its Phase II trial of VERU-111, a novel microtubule depolymerization drug to fight COVID-19. The trial will study 40 hospitalized patients, 20 with VERU-111 and 20 with placebo who tested positive for SARS-CoV-2 and who are at high risk for ARDS.
Lexaria Bioscience submitted a grant application to the NIH for its efficacy modeling of select orally administered antiviral compounds following DehydraTECH formulation enhancement for COVID-19. It will support the company’s second round of panned studies related to COVID-19 treatment possibilities.
Other Industry News
As the COVID-19 pandemic ramped up in March, April and May around the globe, numerous clinical trials for other diseases were paused in order to free up clinics and hospitals as well as to decrease the risk to patients. If companies were able to do so or the disease being studied was critical, trials continued or changes were made to improve access, such as televisits and other approaches. Today, the European Pharmaceutical Review reported a GlobalData study that found more than 200 clinical trials that had been disrupted are now ongoing or completed. This is a 3.2-times increase compared to May.
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones such as predicting the likelihood of testing positive for COVID-19.
A new study published on Wednesday in the journal Nano Letters showed that cellular nanosponges may be able to inhibit SARS-CoV-2 infectivity within the body, ultimately neutralizing the virus.
As reported by The Washington Post, according to two senior White House officials Operational Warp Speed is being pushed to speed up an already unprecedented timeline to approve a coronavirus vaccine sooner than the end of the year.
A report published in the New England Journal of Medicine suggests that blood type might influence an individual’s risk of developing a severe case of COVID-19.