BioCentury | Feb 26, 2021
Product Development

Zaks’ impending departure but the latest milestone as Moderna charts year ahead

As Moderna prioritizes maximizing the reach of its COVID-19 vaccine, Thursday’s announcement of the impending departure of longtime CMO Tal Zaks caps a transformational 14 months for the mRNA company and comes during a year when...
BioCentury | Feb 26, 2021
Product Development

Actions COVID vaccine makers are taking to tackle variants: Data Byte

COVID-19 vaccine developers are taking multiple approaches to combat emerging SARS-CoV-2 variants, ranging from administering additional booster shots of authorized vaccines to developing variant-specific...
BioCentury | Jan 26, 2021
Product Development

Moderna’s two-pronged approach to combating emerging SARS-CoV-2 variants

Moderna is taking a two-pronged approach to addressing potentially weakened vaccine protection against SARS-CoV-2 variants by evaluating an additional booster shot of its current vaccine — a solution...
BioCentury | Dec 18, 2020
Regulation

FDA panel for mRNA-1273 highlights challenges ahead for COVID vaccine trial recruitment, retention

The discussion at Thursday’s FDA advisory committee meeting on a COVID-19 vaccine from Moderna and NIH highlighted the increasing difficulties of conducting trials as more vaccines become authorized and...
BioCentury | Dec 1, 2020
Product Development

Moderna moves & Immunocore breaks through: a BioCentury podcast

After its latest readout positioned the company to seek FDA authorization of its COVID-19 vaccine, Moderna has begun to look ahead to unblinding the Phase III trial of mRNA-1273 so participants who received a placebo can be...
BioCentury | Nov 30, 2020
Product Development

Moderna says Warp Speed improved quality, but not speed of its COVID-19 vaccine development

It took 322 days from the day Moderna produced the first dose of mRNA-1273 for the company to announce Monday that in a Phase III trial its vaccine had prevented 94.1% of symptomatic and 100%...
BioCentury | Oct 29, 2020
Product Development

Vowing transparency at interim COVID-19 vaccine readout, Moderna expects ‘dialogue’ with FDA about unblinding study

Contrasting comments from Pfizer management on Tuesday, Moderna promised full transparency with regard to interim results from its Phase III COVE study of COVID-19 vaccine mRNA-1273. The company pledged to report either a positive or...
BioCentury | Aug 27, 2020
Product Development

Moderna's COVID-19 vaccine may work better in the elderly than competitors’

New Phase I data suggest Moderna’s COVID-19 vaccine maintains its immunogenicity in elderly individuals better than two other leading vaccines. Assuming neutralizing antibodies are key determinants...
BioCentury | Jul 28, 2020
Product Development

With a combined $3B in U.S. funding, two lead mRNA vaccines enter pivotal testing for COVID-19

Partners Pfizer and BioNTech are now neck-and-neck with Moderna as both groups began pivotal testing Monday of their respective mRNA vaccines for COVID-19. Moderna Inc. (NASDAQ:MRNA) received additional funding from Operation Warp Speed, via BARDA,...
BioCentury | Jul 15, 2020
Product Development

Moderna shares touch all-time high as Phase III plans for COVID-19 vaccine take shape

A clearer picture of the late-stage clinical development path for one of the most advanced COVID-19 vaccines is taking shape as Moderna shares additional details of its Phase III trial design for mRNA-1273. The main...
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