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7
Dec
2020

Vaccine Trials: A Band of Brothers and Sisters

On Dec. 2, the New England Journal of Medicine published an article coauthored by many prominent medical scientists, including physicians, who advocated for extending the time in which volunteers in the placebo group enrolled in the Pfizer and Moderna COVID-19 clinical trials should be followed.   Essentially, they are arguing that the study volunteers – people who sacrificed for the...
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3
Dec
2020

AZ’s Muddy Result, Regeneron Cocktail OK’d, and Biogen, Sage Bet Big on Depression

Take two weeks between Frontpoints columns, and a lot of stuff happens. On Monday Nov. 23, AstraZeneca presented a muddy picture from its Phase III clinical trial with a COVID-19 vaccine developed on adenovirus technology with Oxford University. It’s either delivering 90 percent efficacy or 62 percent efficacy, depending on the dose. So it’s either great or good, but we’re...
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1
Dec
2020

Vaccine Scarcity: Buckle Up for Debate

The Pfizer and Moderna vaccines are likely to secure Emergency Use Authorizations (EUAs) from the FDA by Christmas. These are amazing gifts of science. They also arrive with high expectations from a weary public, especially since the clinical trials of these mRNA vaccines indicate near-complete protection from severe disease. These first two vaccines arrive at the most tumultuous time yet...
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1
Dec
2020

COVID-19 Drives New Push for CRISPR-Based Home Diagnostics

Though polymerase chain reaction, PCR, is regarded as the gold standard in molecular diagnostics, the COVID-19 pandemic has taken off some of the shine. Under normal circumstances, samples processed in commercial diagnostic labs that run standard PCR machines can take hours to yield results. In a pandemic, with a surge in demand for tests, turnaround times are creeping upward and...
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23
Nov
2020

A New Model for Vaccine Communications Grounded in Science and Empathy

With COVID-19 cases, hospitalizations and deaths surging, the impressive vaccine results from Pfizer/BioNTech, Moderna and now AstraZeneca arrive just in time to provide some needed hope. But for these vaccines to bring the pandemic to an end, enough people need to be willing to take them. That’s not a given. Various polls have told a story this year about a rising tide...
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20
Nov
2020

Why the Operation Warp Speed Vaccine Studies Aren’t Limited to Severe Disease

[Editor’s Note: a version of this article was first published on Nov. 13 on the Johns Hopkins University Coronavirus Resource Center. —LT ] The COVID-19 Operation Warp Speed (OWS) trials have taken some criticism in the medical press, and lay press, for evaluating what some consider to be “trivial” characteristics of mild COVID-19 disease. Some are arguing that it would...
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18
Nov
2020

The mRNA Vaccine News is Good. But Let’s Keep Masks for Now

[Editor’s Note: a version of this article was first published on the Johns Hopkins University Coronavirus Resource Center. —LT ] Clinical trials are usually designed to answer one or two specific questions. For the pivotal COVID-19 trials evaluating messenger RNA vaccines from Pfizer and Moderna, researchers are looking at whether these vaccines prevent a person from getting sick, keep them...
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12
Nov
2020

Pfizer, BioNTech’s Watershed Moment, Lilly Antibody Gets EUA, & The Rebuilding Begins

First thing Monday, we all woke up to the brightest ray of light in this dark year. Pfizer and Germany-based BioNTech reported that their vaccine candidate was found to be more than 90 percent effective at preventing COVID-19. The report was via press release, not peer-reviewed journal, but this was still a moment to celebrate. The interim analysis wasn’t based...
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11
Nov
2020

Creating the Future of Microbiome-Based Therapies: Simba Gill on The Long Run

Today’s guest on The Long Run is Simba Gill. Simba is the CEO of Cambridge, Mass.-based Evelo Biosciences. Evelo is part of a new generation of biotech companies seeking to make medicines based on new understanding of the microbiome. The science here is fascinating. Evelo’s drug candidates are biologics designed to be taken orally, to act directly in the gut,...
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10
Nov
2020

Biotech Companies Acting on Promises to Increase Racial Diversity

First came the pandemic. Then the economic slump. Then the push for racial justice. Taken together, you have three major challenges for business leaders to tackle all at once. Because the pandemic has illuminated many racial inequalities, these issues have become intertwined. In the biopharma sector, many company leaders stepped up. Decisive moves were made to reorganize working patterns to...
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