Insights

05
Jan
2021

Everything We Know About the New Variant of COVID-19

A new variant of the coronavirus, first detected in the United Kingdom, has prompted dozens of travel bans and strict, tier four mixing rules for millions of people in England, Scotland, and Wales.
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15
Dec
2020

Become a Certified Medical Writing Professional (CMWP)

Medical communication plays a fundamental role in not just research but also regulatory processes, pharmaceutical marketing, health education, and the shaping of public health policies. Medical writers have the challenging task of distilling highly technical information to a variety of stakeholders.
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08
Dec
2020

Understanding Pharmaceutical Guidelines: GLP vs. GMP

The difference between good manufacturing practices (GMPs) and good laboratory practices (GLPs) aren’t always clear. In practice, confusing one for the other can lead to extra work at best and non-compliance at worst.
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24
Nov
2020

FDA Authorizes Most Accurate Antibody Test Yet

On November 25, the US Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for a quantitative antibody test that can detect and measure levels of COVID-specific neutralizing antibodies.
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17
Nov
2020

FDA Approves First At-Home Self-Testing Kit for COVID-19

On November 17, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first at-home self-testing kit for COVID-19.
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10
Nov
2020

New Vaccines Are More Than 90% Effective

On November 9, Pfizer and BioNTech announced that their COVID-19 vaccine candidate showed promising results in Phase 3 clinical trials. Preliminary findings suggest that the vaccine can prevent COVID-19 in more than 90% of people.
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03
Nov
2020

How Effective Does a COVID-19 Vaccine Need to Be?

The “effectiveness” of a vaccine can refer to a constellation of factors: What percentage of vaccinated people develop antibodies? How well do antibodies protect against the disease? How long does this protection last?
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27
Oct
2020

FDA Approves the First Treatment for COVID-19

On October 22, the Food and Drug Administration (FDA) approved remdesivir to treat COVID-19, making it the first and only COVID-19 treatment to have received full federal approval.
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20
Oct
2020

Your Guide to Preparing a Validation Protocol

Validation involves much more than end-product testing. Confirming a product’s safety solely through end-product testing is dangerous—how can you be sure that every pill will be the same?
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13
Oct
2020

FDA Regulatory Relaxations Due to COVID-19

Over recent months, the U.S. Food and Drug Administration (FDA) has relaxed regulations in several areas to keep up with the COVID-19 pandemic. Regulatory relaxations have been made to address interruptions in the supply chain, expedite clinical trials and product reviews, and increase the accessibility of both diagnostic tests and treatments.
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22
Sep
2020

Is the Second Wave of Coronavirus Coming?

On March 11, the World Health Organization (WHO) officially characterized the COVID-19 outbreak as a pandemic. Since then, COVID-19 has swept across the globe. While scientists and public health authorities have made considerable progress in slowing the spread of the virus, the pandemic is by no means over.
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15
Sep
2020

Everything We Know About Convalescent Plasma for COVID-19 Treatment

On August 23, the Food and Drug Administration (FDA) granted an emergency use authorization (EUA) for a novel COVID-19 treatment. Since then, more than 72,000 patients with the virus in the U.S. have been treated with convalescent plasma therapy. But convalescent plasma may not be the answer we were hoping for.
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02
Sep
2020

How to Become a Medical Writer in the Competitive Pharmaceutical Industry

The field of medicine is always expanding. With each new research study, an article communicating the usefulness of its findings is submitted to leading medical journals and other outlets. Submit, review, and publish is the process by which the scientific community and the public at large remain informed about recent developments, driving new research and shaping public policy.

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25
Aug
2020

Healthy and Infected: What We Know About the Asymptomatic Spread of COVID-19

One of the mysteries of the COVID-19 pandemic has been that seemingly healthy individuals can spread the virus to others. This method of transmission, known as asymptomatic spread, has made it difficult to isolate infected individuals and prevent outbreaks.
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18
Aug
2020

FDA Approves Cheaper, Faster Saliva Test for COVID-19

On August 15, the FDA issued an emergency use authorization (EUA) to the Yale School of Public Health for its COVID-19 saliva test, SalivaDirect. While Yale’s saliva test is the fifth of its kind to be FDA-approved, the test is unique in requiring no swab or specialized collection device.
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11
Aug
2020

Antibody Tests for COVID-19: What Can They Tell Us?

On July 31st, the FDA authorized the first two antibody tests designed to give more than a yes-or-no response. Instead of merely indicating the presence or absence of COVID-19 antibodies, these tests display an estimated quantity of such antibodies present in an individual’s blood.
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04
Aug
2020

Quicker, Less Accurate COVID-19 Testing May Be Pivotal to Preventing Outbreaks

To slow the spread of COVID-19, we need better testing. However, as we’re now hearing from leading public health officials, better might not necessarily mean more accurate—at least, not anymore.
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28
Jul
2020

FDA Authorizes First COVID-19 Diagnostic Test for Individuals Without Symptoms

On July 24, the FDA authorized its first COVID-19 diagnostic test for people who haven’t shown any symptoms. This form of broad-based screening is meant to test individuals who don’t suspect that they’ve come into contact with anyone with the disease.
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21
Jul
2020

Pfizer Strikes $1.95 Billion Deal With US Government to Produce Millions of COVID-19 Vaccine Doses

On July 22nd, the US Department of Health and Human Services announced an agreement with Pfizer Inc. for the mass production and nationwide delivery of 100 million COVID-19 vaccine doses. The agreement also reserved an additional 500 million doses for the US. 

Pfizer and its partner, BioNTech, must still complete a phase 3 clinical trial to prove their vaccine’s efficacy. Given approval by the FDA, which would likely come in the form of an EUA, nationwide delivery is set to begin in the last quarter of 2020. 
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