Insights

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.
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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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12
May
2020

FDA Revises Policy on Antibody Tests: New Focus on Access and Accuracy

On March 16th, the U.S. Food and Drug Administration (FDA) issued a policy regarding antibody tests designed to answer population-level questions about the prevalence of COVID-19. The policy was widely criticized for its permissive guidelines as, in recent weeks, more than 250 companies introduced serology tests to the market. In response, the FDA revised its initial policy on May 4th, imposing newly stringent standards for precision.
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05
May
2020

FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment

Since the onset of the COVID-19 pandemic, the Food and Drug Administration (FDA) has worked alongside researchers and innovators with the collective aim of protecting public health. As new treatments are developed, the goal of the administration is to weigh the benefits of these treatments against their potential risks and, if the outcome is favorable, expedite their availability and save as many lives as possible.
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28
Apr
2020

COVID-19: The Race to Find the First Vaccine

The coronavirus (COVID-19) pandemic is on everybody’s minds, from pharmaceutical industry employees to the general public. As deaths and infections rise, governments, businesses in the pharmaceutical industry, health groups, and charities are spending billions of dollars in research for a vaccine.
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21
Apr
2020

The FDA Response to COVID-19 and the Impacts It’s Having on the Pharmaceutical Industry

The United States Food and Drug Administration (FDA) has been adapting its approach in response to the rapidly-evolving COVID-19 pandemic. The coronavirus and its associated quarantine have impacted not only our daily lives but also how we conduct our business.
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14
Apr
2020

The Latest on COVID-19 and the Pharmaceutical Industry

The following is a snapshot of recent news regarding the coronavirus and how the medical community is responding to it. While no currently approved vaccine or treatment is available yet, significant progress and developments have arisen.
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07
Apr
2020

Medical Development Disruptions from COVID-19

From non-essential businesses shutting down to distancing ordinances across major cities around the globe, most people have already felt the effects of the novel coronavirus pandemic (COVID-19). Beyond the economic and social impact of COVID-19, the pharmaceutical industry will experience a significant disruption in drug manufacturing, research, and medical development.
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24
Mar
2020

COVID-19 Update: The Center for Professional Innovation & Education

During this difficult and often confusing time, our primary concern lies with the health and safety of our customers and employees. We are closely monitoring guidance from the CDC and other health organizations regarding how best to keep everyone safe.
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17
Mar
2020

Cybersecurity and Medical Devices: What You Need to Know

The increasing digitization of medical devices has introduced a new threat that the modern pharmaceutical industry fears: the possibility of cybersecurity breaches in our medical equipment. To prevent our essential medical devices from becoming compromised, medical device manufacturers need to ensure they have the proper cybersecurity protocols instilled in their company policies and cultures.
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10
Mar
2020

MIT Discovers Powerful New Antibiotic Using Artificial Intelligence

Recently, a deep-learning model allowed researchers at MIT to discover a powerful new antibiotic that could kill several species of bacteria with antibiotic resistance. This machine-learning algorithm was able to clear infections in two different lab mice.
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