Tag: COVID-19

September 16, 2020

The U.S. Food and Drug Administration (FDA) has completed its review of Vaxart Inc.’s Investigational New Drug (IND) application for its Phase 1 clinical trial evaluating its oral COVID-19 vaccine candidate. “Our goal is to deliver the best, most elegant […]

September 15, 2020

Moderna hired Lonza to make its COVID-19 vaccine in May. Initially, the CDMO will manufacture the vaccine active ingredient—an mRNA molecule in lipid nanoparticles—at plants in the United States and Switzerland. However, the firms plan to establish additional production suites […]

September 14, 2020

Immune reactions caused by vaccination can help protect the organism, or sometimes may aggravate the condition. It is especially important now when multiple vaccines against COVID-19 are being developed. The top immunologists analyse types of immune response to predict what […]

September 10, 2020

Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced updated data from its ongoing Phase 1 study investigating the potential for CPI-006 to provide a novel immunotherapy approach for patients with COVID-19. The results demonstrated that all evaluable […]

September 1, 2020

The COVID-19 pandemic is changing the FDA irrevocably, resulting in a more dynamic, streamlined FDA that is more willing to embrace digital technology, according to panelists at the recent OC LIFe (Lifesciences Innovators Forum) virtual presentation, “COVID-19: Changes In FDA […]

August 24, 2020

A weekend that began with President Trump accusing the FDA on Twitter of stalling the progress of treatments for COVID-19 ended with a press conference in which Trump congratulated agency commissioner Stephen Hahn for issuing a new emergency approval. That […]

August 20, 2020

As the months tick down before the November election, President Donald Trump is seemingly under increasing pressure to find vaccines and treatments for COVID-19. He has touted several unproved drugs as being potentially beneficial and, in recent weeks, has talked […]

August 18, 2020

Therapure Biomanufacturing, a division of Therapure Biopharma Inc., has signed an agreement with VBI Vaccines Inc. for the manufacture of their coronavirus vaccine candidates. Therapure Biomanufacturing is an integrated contract development and manufacturing organization (CDMO) focused on biologic and high […]

August 17, 2020

Although minorities are paying a disproportionate price in the rate of COVID-19 illnesses and deaths, they are underrepresented in clinical trials, a new study finds. The researchers call upon the government, medical journals and funders of research to make sure […]

August 14, 2020

When the Covid-19 pandemic struck the U.S., young biotech company Verve Therapeutics was just months away from a pivotal development: studies in animals of its gene-editing approach to lowering cholesterol that would lead it to be heralded as a potential […]

August 10, 2020

Researchers at the Ragon Institute of MGH, MIT and Harvard, and the University of Washington (UW) School of Medicine, have identified five immune response markers that, collectively, were able to distinguish between those COVID-19 patients who convalesced from the infection, […]

August 5, 2020

Enforcement letter output from the FDA’s advertising watchdog has slowed to zero during the COVID-19 pandemic. Only one letter from Office of Prescription Drug Promotion (OPDP) has been sent in 2020, and that was back in February, before the pandemic […]