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Today's Rundown

J&J starts COVID-19 vaccine phase 3, eyes early 2021 approval
Fujifilm's flu drug Avigan improves COVID-19 recovery time, setting up filing in Japan
Fauci offers defense of why Americans can trust the approval process for a potential COVID-19 vaccine
Dems focus on concerns over COVID-19 as a preexisting condition as they question FDA, CDC directors
FDA to set high bar for emergency COVID-19 vaccine approvals
Biopharma roundup: AZ's US vaccine trial stuck on pause; FDA to release new guidance on emergency use standards: report
Healthcare roundup: Blues plans extend cost-sharing waivers
New insights into the coronavirus spike protein could inspire vaccine development
Humanigen, Thermo Fisher strike deal to scale up manufacturing of monoclonal antibody for COVID-19
Europe progressing in COVID-19 vaccine supply talks with Novavax: report
House government funding bill gives providers relief on Medicare advance payments

Featured Story

J&J starts COVID-19 vaccine phase 3, eyes early 2021 approval

By Nick Paul Taylor

Johnson & Johnson has begun a 60,000-subject phase 3 assessment of its COVID-19 vaccine. The trial will enroll participants in the U.S. and other countries with a high incidence of COVID-19 with a view to generating data to support emergency use authorization early next year.

Fujifilm's flu drug Avigan improves COVID-19 recovery time, setting up filing in Japan

By Eric Sagonowsky

Six months after the World Health Organization declared a global pandemic, the list of drugs proven to work against the virus is very short. On Wednesday, Fujifilm added its flu drug Avigan. The drug passed a phase 3 test in COVID-19 patients with non-severe pneumonia—and could win a green light in Japan as soon as next month.

Fauci offers defense of why Americans can trust the approval process for a potential COVID-19 vaccine

By Tina Reed

Anthony Fauci, M.D., among the most prominent members of the White House Coronavirus Task Force, was addressing the questions of political interference that have been raised in recent weeks as President Donald Trump has indicated a vaccine could be announced before the presidential election.

Dems focus on concerns over COVID-19 as a preexisting condition as they question FDA, CDC directors

By Tina Reed

As the nation's top public health experts testified before a Senate committee Wednesday, Democrats turned the conversation several times back to what they say could become a big problem: COVID-19 as a preexisting condition.

FDA to set high bar for emergency COVID-19 vaccine approvals

By Nick Paul Taylor

The FDA is set to take a tough line on the evidence required to support emergency use authorization (EUA) of COVID-19 vaccines, according to The Washington Post. The reported requirements suggest a company is unlikely to have the data needed to support an EUA before the election in six weeks.

Biopharma roundup: AZ's US vaccine trial stuck on pause; FDA to release new guidance on emergency use standards: report

By Eric Sagonowsky, Angus Liu, Kyle Blankenship, Conor Hale, Fraiser Kansteiner

AstraZeneca's U.S. vaccine trial remains on hold. The FDA is fleshing out its standards for a vaccine emergency nod, the Washington Post reported. Researchers ID'd a new potential target for COVID drugs and vaccines. And less than half of U.S. voters plan to get a shot once it's available, a new survey found.

Healthcare roundup: Blues plans extend cost-sharing waivers

By Healthcare Staff

Follow along with the latest COVID-19 news straight from the Fierce Healthcare team.

New insights into the coronavirus spike protein could inspire vaccine development

By Angus Liu

A team led by scientists at the University of California, San Diego focused its COVID-19 research on glycans, which are sugar molecules that shield the virus's spike protein. The researchers revealed an essential role of N-glycans at two sites on SARS-CoV-2 they say offers a novel pathway for vaccine development.

Humanigen, Thermo Fisher strike deal to scale up manufacturing of monoclonal antibody for COVID-19

By Kyle Blankenship

In the earliest days of the COVID-19 pandemic, a suite of drugmakers looked to monoclonal antibodies as a possible therapy for the immune system overreaction seen in severe patients. Months later, most of those candidates have had mixed success, but Humanigen is pressing ahead—and it's bringing on partners to help scale for market.

Europe progressing in COVID-19 vaccine supply talks with Novavax: report

By Eric Sagonowsky

Having struck COVID-19 vaccine supply deals with AstraZeneca and the partnership between Sanofi and GlaxoSmithKline, European officials are advancing in talks with Novavax, Reuters reports.

House government funding bill gives providers relief on Medicare advance payments

By Robert King

A House government funding bill would help providers with repaying massive Medicare advance payment loans, a major ask from hospital groups.

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