emergency

This page lists current and terminated Emergency Use Authorizations that make available diagnostic and therapeutic medical devices to diagnose and respond to public health emergencies.

 

Scott Gottlieb

This report provides a road map for navigating through the current COVID-19 pandemic in the United States. It outlines specific directions for adapting our public-health strategy as we limit the epidemic spread of COVID-19 and are able to transition to new tools and approaches to prevent further spread of the disease. We outline the steps that can be taken as epidemic transmission is brought under control in different regions. These steps can transition to tools and approaches that target those with infection rather than mitigation tactics that target entire populations in regions where transmission is widespread and not controlled. We suggest measurable milestones for identifying when we can make these transitions and start reopening America for businesses and families.

 

This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses. A novel coronavirus, named Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China in 2019. The illness caused by this virus has been named coronavirus disease 2019 (COVID-19). (CDC/Alissa Eckert, MS)

NEW BRUNSWICK, N.J., March 30, 2020 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine. The Company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process.

 

Johns Hopkins doctor identifies 5 major conditions for relaxing social distancing Fox News

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Dr. Thomas Inglesby, director of the Johns Hopkins Center for Health Security, warned that the U.S. is "still at the beginning" of the coronavirus outbreak, and outlined five conditions that must be met before the country should consider relaxing social distancing practices.

 

Question Mark Hand Drawn Solution Free photo on Pixabay

In the third week of February, as the covid-19 epidemic was still flaring in China, I arrived in Kolkata, India. I woke up to a sweltering morning—the black kites outside my hotel room were circling upward, lifted by the warming currents of air—and I went to visit a shrine to the goddess Shitala. Her name means “the cool one”; as the myth has it, she arose from the cold ashes of a sacrificial fire. The heat that she is supposed to diffuse is not just the fury of summer that hits the city in mid-June but also the inner heat of inflammation. She is meant to protect children from smallpox, heal the pain of those who contract it, and dampen the fury of a pox epidemic.

 

This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses. A novel coronavirus, named Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China in 2019. The illness caused by this virus has been named coronavirus disease 2019 (COVID-19). (CDC/Alissa Eckert, MS)

Thirty thousand base pairs make up the (relatively tiny) SARS-CoV-2 genome. A singular genome holds limited information. But, by comparing multiple genomes from different patients, animals, places, or time periods, the DNA’s information can be unlocked. From where the virus originated to how it spilled over from animals into humans, how quickly it mutates, and how those changes affect infections—genome comparisons may provide the answers.

Image: This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses. A novel coronavirus, named Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China in 2019. The illness caused by this virus has been named coronavirus disease 2019 (COVID-19). (CDC/Alissa Eckert, MS)

Novel Coronavirus SARS CoV 2 Coronavirus disease 2019 Wikipedia

Bloomberg Philanthropies and the state of Maryland will spend $4 million to back a Johns Hopkins University study into whether the blood of recovered COVID-19 patients can be used to treat patients suffering from the disease.

The effort will also include researchers from nearly two dozen institutions, including the Mayo Clinic, Stanford University Medical Center and the Albert Einstein College of Medicine. Arturo Casadevall, a professor at the Johns Hopkins University Bloomberg School of Public Health and the Johns Hopkins School of Medicine, will lead the study.

 

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Sometimes, business success requires someone who has your back.

Now in its sixth year, 757 Angels continues to support start-ups in Hampton Roads and elsewhere by investing capital in them.

The Angel Capital Association, a national industry alliance based in Kansas, named 757 Angels as one of the nation’s top 10 angel groups, by total dollars invested, for 2018.

And last year, 757 Angels saw continued growth, and its biggest year, as the group invested $15 million in 11 companies.

Image: Monique Adams, executive director of 757 Angels, gives a talk.(Courtesy of 757 Angels)

Emergent BioSolutions logo

Medical biotech company Emergent BioSolutions is one of the many health industry players turning its efforts towards addressing the current global coronavirus pandemic. Their work includes a two-pronged effort to pursue plasma-based treatments that could help lessen the impact of COVID-19 on health care systems, with a fast-tracked development timeline that could see human clinical trials start as soon as this summer.

 

Man in Blue Collared Top Using Imac Indoors Free Stock Photo

The study of the COVID-19 pandemic often involves sequencing the SARS-CoV-2 virus using Illumina, Nanopore, IonTorrent and Sanger technologies alone or in combination. Depending on the sampling and library preparation method used, this can involve metatranscriptomic data of varying viral content.

In this webinar tutorial, the following topics will be discussed:

  • Best practices for bioinformatic analyses using the versatile QIAGEN CLC Genomics Workbench
  • QC, adapter trimming and strategies for host read depletion and viral content enrichment
  • Simple pipelines for assembly and strain identification
  • A demonstration of read mapping, variant calling and consensus sequence extraction, which are necessary steps for obtaining high-quality genomic sequences for phylogenetic analysis and publication

 

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QIAGEN N.V. QGEN announced that it started shipping its new QIAstat-Dx Respiratory SARS-CoV-2 Panel test (which is to be sold as an in-vitro diagnostic or IVD) in the United States to help diagnose coronavirus-infected patients. The announcement came after a new policy of an Emergency Use Authorization (EUA) was declared by the FDA early this month. Notably, the company will submit the related EUA to the FDA this week.

Image: https://www.nasdaq.com

results

Gentian Diagnostics AS is pleased to announce that the results from a study conducted in collaboration with University College of London (UCL) are published in Critical Care 2020, Meeting Abstracts from the 40th International Symposium on Intensive Care & Emergency Medicine. The results indicate that calprotectin can be used as an early biomarker for infection and inflammation. The study also shows earlier release of calprotectin compared to other conventional biomarkers (procalcitonin and C-reactive protein (CRP)). Early activation of immune response and recognition of bacterial infection and sepsis is a key step for early and correct initiation of antibiotic treatment. Calprotectin is released by neutrophils upon their activation and may thus act as an early biomarker of inflammation and bacterial infection.

 

Meet the seven people who are helping Maryland Gov Larry Hogan make coronavirus decisions Baltimore Sun

When Maryland Gov. Larry Hogan decides to close nonessential businesses, bars and restaurants and limit public gatherings, he isn’t doing so all on his own.

Hogan has a team of seven public health specialists that he consults as he figures out how to grapple with the coronavirus pandemic.

Even without an official shelter-in-place order like a handful of other states have implemented, Maryland has some of the strictest rules across the nation to contain the spread of COVID-19.

Image: Dr. Linda Singh, interim executive director and CEO of TEDCO and a retired major general in the Maryland National Guard, is among the seven public health specialists Maryland Gov. Larry Hogan consults with regularly during the coronavirus pandemic. Here they talk in April 2018 at Aberdeen Proving Ground.(Kenneth K. Lam / Baltimore Sun)

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Our team has served the BioHealth Capital Region for over a decade. In those efforts, we’ve also helped to shape and support the vibrant community we’re so proud to call home.

Over the course of recent weeks, communities have closed schools and businesses in the best interest of public health and safety. Rest assured that many companies in our region are working in unison to address Novel Coronavirus.

Image: https://biobuzz-io.cdn.ampproject.org

Sally Allain

As the world responds to the COVID-19 pandemic, we are seeing both the value and the need for public-private partnerships to quickly get much-needed medical innovations and technologies to combat infection in the hands of healthcare workers, patients and the general public. In collaboration with government authorities, private companies have stepped up to the plate to manufacture, with urgency, the diagnostic test kits required to identify those with infection. And others, like Johnson & Johnson, are working tirelessly with the aim to identify a vaccine to prevent future outbreaks.