Biopharma Update on the Novel Coronavirus: May 13
News information is not all-inclusive. Please check back for updates.
FDA Actions
Warning Letters: The FDA and FTC issued a warning letter to Fusion Health and Vitality LLC for selling fraudulent COVID-19 products. To date, there have been 48 COVID-19 related warning letters.
Blood Establishments: The FDA provided more information for blood establishments for COVID-19, aligning with the guidance on convalescent plasma to allow donation 14 days after symptoms are gone.
EUAs: The FDA issued a EUA for the Ascom teleCARE IP Nurse Call System and a EUA for the Eko electrocardiogram (ECG) Low Ejection Fraction Tool (“ELEFT”).
Diagnostics Update: The FDA has worked with more than 500 test developers who plan to submit EUA requests to detect COVID-19. Also, 93 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.
Diagnostics
U.S. works with clinical laboratories to launch several large-scale COVID-19 serological surveys to detect and track undetected cases of COVID-19. The first study is funded by the NIH and is taking place in Seattle, New York City, San Francisco, Los Angeles, Boston, and Minneapolis. The testing is to identify patients with antibodies against SARS-CoV-2 in order to determine if they have been exposed to the virus.
Creoptix AG is collaborating with University of Zurich professor Adriano Aguzzi to characterize immunological responses to SARS-CoV-2, such as IgA, IgM and IgG antibodies. They will use the Creoptix WAVEsystem, a label-free bioanalytical instrument that allows antibody detection in even pure serum or plasma.
Testing Therapies, Antivirals and Vaccines
As reported by CNBC, Pfizer’s CEO and Chairman Albert Bourla said the company has plans to take its experimental COVID-19 vaccine and expand human trials to thousands of test patients by September.
Company Actions
Currently, Gilead Sciences has the only drug shown to be effective against COVID-19, antiviral drug Veklury (remdesivir). The company has now entered into licensing agreements with five generic drugmakers to make the drug available in 127 countries. They are Mylan, Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences.
Boston-based GreenLight Biosciences closed an oversubscribed $17 million “special purpose funding round” in order to expand its scalable mRNA manufacturing capability for its mRNA COVID-19 vaccine. The goal is to be able to produce billions of doses.
Karyopharm Therapeutics announced a new initiative to donate and distribute 60,000 medical masks to some of the most vulnerable individuals impacted by the ongoing COVID-19 pandemic including cancer patients, their families, and the healthcare workers caring for them. Karyopharm will donate masks to Family Reach, Myeloma Crowd and The Leukemia & Lymphoma Society, three prominent organizations focused on the well-being of cancer patients, to improve the safety and security of the broader cancer community.
Due to the extension of an emergency order issued by the governor of Massachusetts to May 18, Sweden-based Immunovia's lab located in Marlborough, Mass. will remain closed. As an effect of COVID-19, Immunovia revised its timeline and sales start date for IMMray PanCan-d, for the fourth quarter of 2020. This decision factors in the possibility of any further extensions by the government of Massachusetts to the beginning of June, the company said.
Other Industry News
As reported by CNBC, Stephane Bancel, Moderna’s CEO, said that no single manufacturer can meet global demand for coronavirus vaccines. Regeneron CEO Leonard Schleifer told CNBC the problem isn’t with the physical distribution but rather with the ability to meet demand.
In an interview with “Closing Bell”, Melinda Gates said scientists and experts may find a vaccine that is safe and effective by the end of the year, if lucky.
Atrium Health is the first major health system in the nation to put into wide practice a point-of-care ultrasound (POCUS) device in a collaboration with Butterfly Network as health systems look to imaging innovation in the wake of COVID-19. This POCUS device features a hand-held probe that connects to a smartphone or tablet, allowing a physician to quickly and safely examine various areas of a patient’s body.
Researchers at Augusta University may have uncovered a clue as to why seniors are more vulnerable to COVID-19. As individuals age microRNA molecules diminish. MicroRNA molecules play a big role in gene expression and they also fight viruses when they invade the body.