Biopharma Update on the Novel Coronavirus: September 11

CV Update_September 11

News information is not all-inclusive and updates are published on Mondays, Wednesdays and Fridays. 


FDA Actions

Warning Letter: The FDA and FTC issued a warning letter to Pharmacy Plus, Inc. dba Vital Care Compounder for selling products with fraudulent COVID-19 claims.

Diagnostics Update: To-date the FDA has authorized 247 individual EUAs, which include 197 molecular tests, 46 antibody tests and 4 antigen tests.


Testing Therapies, Antivirals and Vaccines

In a private call with investors from J.P. Morgan late Wednesday, AstraZeneca Chief Executive Officer Pascal Soriot confirmed that a woman injected with the company’s experimental COVID-19 vaccine candidate developed a serious spinal inflammatory disorder called transverse myelitis. Please read more here

AstraZeneca said it should know before the end of the year whether it’s experimental COVID-19 vaccine would protect people, if the trials are allowed to resume. Despite a temporary pause on its COVID-19 vaccine trial, AstraZeneca Chief Executive Officer Pascal Soriot said the preventative drug could still be available for commercial use by the end of the year, or in early 2021 barring any other setback. Please read more here

The National Institutes of Health launched two of three Phase III clinical trials evaluating blood thinners to treat adult COVID-19 patients. This is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative. The trial, which will be coordinated by the University of Pittsburgh, will involve patients in various clinical settings.

The University of Pittsburgh was chosen by the NIH to lead three Phase III clinical trials involving COVID-19 patients. They are dubbed ACTRIV-4 Antithrombotics, and they will evaluate the use of blood thinners in saving lives and improving care, especially in adult COVID-19 patients at risk of life-threatening blood clots.

Diffusion Pharmaceuticals dosed the first two patients in its Phase Ib lead-in trial of its novel, oxygen-enhancing therapeutic, trans sodium crocetinate in 24 hospitalized COVID-19 patients. In addition to safety, the trial will gather preliminary data on the therapy’s effects on arterial blood oxygenation. It is being run by the Romanian National Institute of Infectious Diseases.


Company Actions/Announcements 

As reported by CNBC, AbbVie told employees that working at the office an important part of their collaborative cross-function culture and has asked U.S.-based teams to return to the office. However, some employees don’t feel safe commuting to the office or working with other associates in person.

On Thursday, the head of the FDA, Stephen Hahn said he would not overrule scientists at the agency regarding a COVID-19 vaccine approval.

Centogene expanded its SARS-CoV-2 testing capacity at Frankfurt Airport to continue supporting safe travel for passengers as international borders open amid the new normal.

As reported by the Boston Business Journal, due to the COVID-19 pandemic, MassBio has been forced to lay off employees.


Other Industry News

In a paper detailing their study, researchers have found that lowering speaking volume can help reduce the spread of COVID-19.

Six months into a global pandemic and public trust is waning in its support for public health officials in charge of the nation’s response to the novel coronavirus, according to a new poll. The poll, conducted by the Kaiser Family Foundation from Aug. 28 to Sept. 3, paints a dreary picture of the public’s attitude regarding the pandemic ahead of the November presidential election. Please read more here.

Back to news