Tag: COVID-19

FDA, Regulations

FDA Clears IND Application for Vaxart Oral COVID-19 Vaccine

September 16, 2020

Via: Contract Pharma

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 […]

Industry, Vaccines

Automation a Key Focus for Moderna’s COVID-19 Vaccine Contractor

September 15, 2020

Via: Genetic Engineering and Biotechnology News

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 […]

Clinical Trials, Research and Development

Which immune response could cause a vaccine against COVID-19?

September 14, 2020

Via: World Pharma News

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 […]

Clinical Trials, Research and Development

Corvus Pharmaceuticals Provides Update on Clinical Trial of CPI-006 for Patients with COVID-19

September 10, 2020

Via: BioSpace

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 […]

FDA, Regulations

How COVID-19 is Changing FDA Approval and Clearance Processes

September 1, 2020

Via: BioSpace

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 […]

FDA, Regulations

FDA ends pressure-packed weekend with emergency OK for blood-derived COVID-19 treatment

August 24, 2020

Via: Biopharma Dive

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 […]

FDA, Regulations

Trump accuses FDA of playing politics with last-minute COVID-19 plasma delay

August 20, 2020

Via: FierceBiotech

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 […]

Industry, Manufacturing, Research and Development, Vaccines

Therapure Signs Manufacturing Deal with VBI Vaccines

August 18, 2020

Via: Contract Pharma

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 […]

Clinical Trials, Research and Development

COVID-19 Clinical Trials Lack Diversity, Researchers Say

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 […]

Cell and Gene Therapy, Industry

How a biotech CEO figured out Covid-19 surveillance testing for 50 companies with 12-hour turnaround times

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 […]

Clinical Trials, Research and Development

COVID-19 Patients Exhibit Early Antibody Signatures Potentially Predictive of Death or Recovery

August 10, 2020

Via: Genetic Engineering and Biotechnology News

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, […]

FDA, News, Regulations

FDA ad police’s warning letters have stalled during COVID-19, and that’s likely the new norm: expert

August 5, 2020

Via: FiercePharma

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 […]