Tag: Coronavirus

October 15, 2020

Coronavirus clinical trials from drug giants Johnson & Johnson and Eli Lilly hit a snag this week after safety monitors halted them over bad reactions from participants. J&J said Monday it paused the late-stage trial of its coronavirus vaccine candidate […]

October 6, 2020

The weeklsong tug-of-war between the FDA and the White House over the agency’s guidelines — normally a routine part of regulatory standard-setting — came to a head in less than 24 hours. After both The New York Times and Politico […]

September 25, 2020

More than 30 biotech and pharmaceutical companies are racing to develop a safe Covid-19 vaccine. Several candidates entered late stage trials in a matter of months. Two of the companies developing a vaccine — Pfizer and Moderna — are utilizing […]

September 10, 2020

The head of the Food and Drug Administration on Thursday said he has “no intention” of overruling career scientists at the agency on an approval of a coronavirus vaccine even though he has the authority. FDA Commissioner Stephen Hahn said […]

August 27, 2020

The first rapid coronavirus test that doesn’t need any special computer equipment to produce results was approved by the U.S. Food and Drug Administration on Wednesday. Made by Abbott Laboratories, the 15-minute test will sell for $5, giving it an […]

August 21, 2020

The Trump administration has blocked the U.S. Food and Drug Administration from regulating a wide swath of laboratory tests, including ones for the coronavirus. The new policy, which was posted Wednesday and is strongly opposed by the FDA itself, stunned […]

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 […]

July 28, 2020

As the U.S. coronavirus case count passed 4.3 million on Monday, companies launched the final phase of testing for two potential COVID-19 vaccines. In one trial begun on Monday, the first of 30,000 volunteers were either given a vaccine developed […]

July 10, 2020

The news Friday comes about two months after FDA shared in an update it was using the White House guidelines on reopening and working with the Centers for Disease Control and Prevention to get inspections up and running again even […]

May 7, 2020

Global coronavirus vaccine makers have been rolling out details about their manufacturing and launch plans—even ahead of any clinical data. Now, Pfizer says it will draw on three sites in the U.S., plus one in Belgium, for the early stages […]

April 29, 2020

President Donald Trump said he wants the Food and Drug Administration to move “as quickly as they can” to approve Gilead Sciences’ antiviral drug remdesivir as a treatment for the coronavirus. “We would like to see very quick approvals, especially […]

April 9, 2020

The results of research by University of British Columbia scientists suggest that giving up smoking could lessen the chance that an infection with SARS-CoV-2 coronavirus will lead to severe COVID-19 disease. Their studies found that the lung cells of people […]

April 1, 2020

The U.S. has become the epicenter of the global pandemic, with a total of 141,000 cases and 2,400 deaths as of March 31, according to the World Health Organization. The White House has now acknowledged that the death toll in […]

March 24, 2020

The U.S. Food and Drug Administration (FDA), on March 23, announced the following actions in its ongoing response effort to the COVID-19 pandemic: • The FDA issued a safety alert for fecal microbiota transplantation (FMT) procedures. The FDA has issued […]

March 23, 2020

Compassionate use, as Gilead noted in its Sunday statement, was not designed to facilitate widespread access to experimental drugs during a public health emergency. So far, the biotech has provided remdesivir to “several hundred” patients sick with COVID-19 in the […]

March 19, 2020

President Donald Trump said Thursday he directed the Food and Drug Administration to investigate whether an existing drug for malaria can be used to treat the coronavirus. There are no proven therapies for the COVID-19 virus, which has rapidly grown […]

March 16, 2020

In response to the global COVID-19 pandemic, Medable has developed a new TeleVisit mobile application that can be used by patients worldwide to connect virtually with their clinical trial sites. The application makes it possible for clinical trial research to […]

March 16, 2020

Former FDA Commissioner Scott Gottlieb told CNBC on Monday that he believes the coronavirus will peak in the U.S. from around late April to early May, a timeline that suggests a longer crisis than some politicians are indicating. Gottlieb, in […]

March 13, 2020

As COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus continues to spread across the globe, Vancouver-based AbCellera and Eli Lilly have teamed up to co-develop antibody products for the treatment and prevention of the virus that was declared a […]

March 6, 2020

President Donald Trump this morning signed into law an $8.3 billion measure designed in part to fund the development of vaccines, therapies, and diagnostic tests for SARS-CoV-2—the virus at the center of the global COVID-19 outbreak. The emergency supplemental appropriations […]