Newsletter Tool

To view this email as a web page, click here

Today's Rundown

Novavax COVID-19 vaccine hits 90% efficacy in pivotal U.S. trial
How did 75 million J&J vaccines get ruined? FDA details the manufacturing woes at Emergent's beleaguered site
Judge dismisses lawsuit contesting Houston Methodist's mandatory COVID-19 vaccine policy
J&J's Burton grabs hold of Moderna rocket ship as the vaccine developer's next chief medical officer
Humanigen angling to go from zero to $1B with U.S., U.K. COVID-19 therapy filings
UPDATED Coronavirus tracker: Routine pediatric vaccinations fell behind schedule during pandemic
Celltrion's COVID-19 antibody gets a phase 3 win as virus variants snare existing therapies
Diabetes mainstay metformin tamps down lung inflammation in COVID models
COVID-19 tracker: Novavax shot posts 90% efficacy in late-stage trial; WTO chief warns against rising trade barriers
HiFiBiO gets high-five from investors with $75M series D to bring two programs into clinic

Featured Story

Novavax COVID-19 vaccine hits 90% efficacy in pivotal U.S. trial

By Nick Paul Taylor

Novavax’s COVID-19 vaccine candidate has achieved 90.4% efficacy in the pivotal trial designed to support U.S. approval. The phase 3 data set Novavax up to file for approval in the third quarter.

How did 75 million J&J vaccines get ruined? FDA details the manufacturing woes at Emergent's beleaguered site

By Fraiser Kansteiner

At long last, several million doses of Johnson & Johnson's COVID-19 vaccine made at CDMO Emergent BioSolutions' troubled Baltimore production facility have been cleared for use. But many more are now bound for the graveyard, and the feds are going public with the reasons behind the ruined doses.

Judge dismisses lawsuit contesting Houston Methodist's mandatory COVID-19 vaccine policy

By Dave Muoio

Requiring the vaccine does not constitute coercion because employees who decline to receive it may seek employment elsewhere, the judge said. The dismissal came less than a week after the system suspended 178 employees who had not received the vaccine.

J&J's Burton grabs hold of Moderna rocket ship as the vaccine developer's next chief medical officer

By Annalee Armstrong

Moderna launched itself into the big leagues last year with its COVID-19 vaccine, and now it's poaching talent from the world’s biggest healthcare company. Paul Burton, M.D., Ph.D., will join the Cambridge, Massachusetts-based biotech as chief medical officer from Johnson & Johnson’s Janssen unit.

Humanigen angling to go from zero to $1B with U.S., U.K. COVID-19 therapy filings

By Annalee Armstrong

Humanigen could go from zero to $1 billion in sales if its COVID-19 treatment clears regulatory review in the U.S. and U.K., analysts from Cantor Fitzgerald said today. The self-described “cytokine storm company” filed a rolling submission in the U.K. Monday for lenzilumab in hospitalized COVID-19 patients. This follows a May 28 authorization request submitted to the FDA.

UPDATED Coronavirus tracker: Routine pediatric vaccinations fell behind schedule during pandemic

By Healthcare Staff

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

Celltrion's COVID-19 antibody gets a phase 3 win as virus variants snare existing therapies

By Amirah Al Idrus

Chalk one up for COVID-19 antibodies: Celltrion’s prospect, regdanvimab, beat placebo at preventing hospitalization and death in patients with mild to moderate symptoms and helped those patients recover more quickly in a phase 3 study. The results arrive as the rise of SARS-CoV-2 variants raise concerns about existing antibody drugs, especially those given as single agents.

Diabetes mainstay metformin tamps down lung inflammation in COVID models

By Arlene Weintraub

The 27-year-old diabetes drug metformin has been studied for its potential use in a wide range of other disorders, including heart disease and cancer. Now researchers led by the University of California, San Diego, say the diabetes mainstay might help prevent lung inflammation in patients with COVID-19.

COVID-19 tracker: Novavax shot posts 90% efficacy in late-stage trial; WTO chief warns against rising trade barriers

By Noah Higgins-Dunn,Kevin Dunleavy,Fraiser Kansteiner

Novavax said its vaccine was 90.4% effective against COVID-19 in late-stage testing, setting the company up for an FDA filing in the third quarter. The head of the World Trade Organization warned against rising pandemic-related trade barriers. And more headlines.

HiFiBiO gets high-five from investors with $75M series D to bring two programs into clinic

By Kyle LaHucik

HiFiBiO has another $75 million to take two lead antibody oncology programs into the clinic and continue the phase 1 study of its COVID-19 antibody candidate. Mirae Asset Financial Group led the Series D round alongside half a dozen other new investors like B Capital Group.

COVID-19 Tracker