Insights

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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14
Jul
2020

Moderna's Phase 3 COVID-19 Vaccine Trial Will Begin Later This Month

The WHO marked the six-month anniversary of the COVID-19 outbreak on June 29th. After six grueling months of widespread deaths and economic shutdowns, people are desperate for a glimmer of hope. For many, Moderna’s mRNA vaccine—which saw human trials in a record-breaking 63 days—is more than just a glimmer of hope, it’s a potential solution.
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06
Jul
2020

The Race Toward a COVID-19 Vaccine: Three Months Later

As of July 2020, more than 11 million cases of COVID-19 have been reported worldwide, with the number of deaths at half a million and counting.
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30
Jun
2020

How to Improve Your Medical Writing: The Basics and More

Medical research is a never-ending journey. Fresh hypotheses, innovative methods, and growing clinical experience all contribute to the ever-expanding field of medicine. And with every discovery about a disease or its treatment, information must be effectively conveyed to many audiences, from healthcare professionals and drug regulators to patients and the general public
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23
Jun
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.
Continue Reading ?
16
Jun
2020

Accuracy Concerns With COVID-19 Diagnostic Test

The FDA has alerted the public to preliminary data suggesting that a COVID-19 diagnostic test may yield inaccurate results. In particular, Abbott’s ID NOW, a test that is being used to examine White House officials, may have led to missed cases of COVID-19 and infected patients who have been falsely cleared.
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09
Jun
2020

FDA Authorizes First Standalone, At-Home Sample Collection Kit for COVID-19

The FDA has authorized Everlywell’s standalone, at-home sample collection kit for COVID-19, the first of its kind to receive an emergency use authorization (EUA) for use with multiple diagnostic tests. 
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26
May
2020

How We Can Prepare the Pharmaceutical Supply Chain for the Coronavirus

Pandemics and their associated lockdowns, distancing measures, and economic interruptions can have massive implications for global supply chains. The pharmaceutical industry suffers this fate thanks to the recent COVID-19 coronavirus disease.
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19
May
2020

Should the Pharmaceutical Industry Address Overseas Manufacturing Amid COVID-19?

Recent reports from the United States Food and Drug Administration (FDA) have shown that only 28% of manufacturing for active pharmaceutical ingredients occurs within the nation. While international collaboration on commerce and health are not uncommon, the recent COVID-19 coronavirus pandemic has introduced concerns on whether the country should remain reliant on external supply chains.
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