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.

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.

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.

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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.

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.

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)

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.

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)

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.

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

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

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.

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)

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

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.

The EIC is organising a special ePitching-session in the light of the current COVID-19 outbreak in an effort to mobilize EIC projects. All EIC-backed SMEs that can contribute to possible solutions to help combat the current pandemic and its consequences and are looking for investment are welcome to apply. 

A limited number of EIC-backed up SMEs will then have the chance to show their innovative solutions via an online tool to a jury of investors, including Panakes Partners, Idacapital, Clinical Research Ventures, Monte Carlo Capital, Illumina Ventures, Capricorn Venture Partners, Diffusion Capital Partners on 15 April 2020 from 12.00 till 1.30 pm (CET).

Image: https://en.wikipedia.org/wiki/Coronavirus_disease_2019#/media/File:Novel_Coronavirus_SARS-CoV-2.jpg

Gaithersburg’s Novavax Inc. (NASDAQ: NVAX) has been in the spotlight since January for its work on a novel coronavirus vaccine, but it will need more support to advance the program at the necessary speed, its head of research said Monday.

The Maryland biotech is now moving toward a phase 1 clinical trial after pulling in support from local players.

Two months after it started, “we’re very clearly confident that we can make a vaccine,” said Dr. Gregory Glenn, its president of research and development.

GAITHERSBURG, Md., March 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced positive top-line results of its pivotal Phase 3 clinical trial of NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate with its proprietary Matrix-M™ adjuvant, in adults aged 65 and older. Using the Food and Drug Administration’s (FDA) criteria for accelerated approval of seasonal influenza vaccines, the trial evaluated the immunogenicity and safety of NanoFlu compared to Fluzone® Quadrivalent, a U.S.-licensed quadrivalent influenza vaccine.

There is a desperate need for new medicines to treat Covid-19, the disease caused by the novel coronavirus that has shut down much of the world. A vaccine to prevent infection entirely would be even better.

Drug companies and medical researchers are making heroic efforts to deliver new medicines. Several dozen are now in development, and you can see highlights of those efforts here. Studies so far are mostly small and lack real control groups, making it hard for researchers to be sure of their conclusions. 

The BioHealth Capital Region (BHCR) and its life science ecosystem have a rich and deep history of pioneering scientific innovation, research, development, and commercialization. The region’s history has been written by life science anchor companies, scientific research universities, government research organizations, rich startup culture, and serial entrepreneurs, all of whom have played critical roles in transforming the BHCR into one of the most innovative and productive biocluster in the world. 

Image: https://biobuzz.io/

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that Thierry Bernard has been namedChief Executive Officer.

Additionally, a Joint Meeting of the Supervisory Board and the Managing Board has resolved to propose Mr. Bernard, who has been with QIAGEN since 2015, for election as Chief Executive Officer and a Managing Director at the next Annual General Meeting, which is set to take place in June 2020, along with the re-election of Roland Sackers as Chief Financial Officer and a Managing Director. The Joint Meeting further resolved to propose the current members of the Supervisory Board to all stand for re-election: Håkan Björklund, Stéphane Bancel, Metin Colpan, Elaine Mardis, Lawrence Rosen and Elizabeth Tallett.

Image: https://corporate.qiagen.com/

Johns Hopkins University's COVID-19-tracking map has leveled up to show more granular data on the number of confirmed novel coronavirus cases around the globe.

Since January, well before the coronavirus began rapidly infecting people in the United States, a team from Johns Hopkins University had been tracking the virus’ spread in China and other countries worldwide. Now, a little over two months since launching the interactive map, the tool now shows data reflecting real-time confirmed cases in cities and localities across the U.S. and internationally.

Image: https://www.bizjournals.com

(Reuters) - German molecular testing company Qiagen NV (QIA.DE) said on Tuesday it has begun shipping its diagnostic test for COVID-19 to the United States.

The test kit, QIAstat-Dx Respiratory SARS-CoV-2 Panel, requires less than one minute for sample preparation and can deliver results in about one hour, the company said.

Shipments come under a new policy laid out by the U.S. Food and Drug Administration earlier this month to help accelerate the availability of coronavirus diagnostic tests, developed by laboratories and commercial manufacturers during the public health emergency.

The world might be facing turmoil and uncertainty — states that Novavax Inc. knows all too well — but today, the Gaithersburg biotech has reason to celebrate.

The company has reported positive results for its late-stage clinical trial of seasonal flu vaccine NanoFlu, marking its first successful phase 3 study after two devastating failures. These latest results now open an otherwise impenetrable door with a product candidate viewed as Novavax's last best chance for success — and its first-ever commercial product in more than 30 years of operation.

No vavax is cel e brat ing tri al re sults again four years af ter a Phase III fail ure in RSV sent their stock price off a cliff.

The com pa ny an nounced that their re com bi nant flu vac cine NanoFlu met all pri ma ry and sec ondary end points in a Phase III study of 2,652 adults old er than 65. The num bers, No vavax sug gest ed, should al low them to clear reg u la to ry hur dles and snag the biotech’s first ap proval since its found ing in 1987.

In honor of the new JLABS @ Washington, DC – a 32,000 square foot facility located on the new Children’s National Research and Innovation Campus, Johnson & Johnson Innovation – JLABS launched the JLABS @ Washington, DC Children’s QuickFire Challenge.

Visionaries within the fields of pediatric oncology, pediatric surgery and influenza are invited to submit innovative ideas for up to $150,000 in total grant funding; one year of residency at JLABS @ Washington, DC; and mentorship.

BioHealth Capital Region COVID19 Resources:

In these uncertain times, we are proud to have so many BioHealth Capital Region federal, state, local and private sector organizations focused on combatting COVID19.  Please use these links to stay abreast of the last news and resources available for your business.

District of Columbia 

Maryland

• Governor's Update - https://governor.maryland.gov/coronavirus/
• General Update - https://coronavirus.maryland.gov/
• Business Resources - https://govstatus.egov.com/md-coronavirus-business\

Montgomery County, MD

Virginia

US Small Business Administration 

Volunteers

As our community responds to COVID-19, Adventist HealthCare hospitals are caring for those most impacted by the virus in our community. Their need for health care professionals will grow more urgent as the number of local cases increase. As part of its preparedness planning, Adventist HealthCare is asking the research community to help. They are looking for physicians, nurses or technicians who could assist with testing, registration and patient care. If you would be willing to serve Adventist HealthCare during this unprecedented time, please contact Yasmin Nasser at (This email address is being protected from spambots. You need JavaScript enabled to view it./301-315-3220) to be added to a list of reserve employees. Whether you are social distancing and practicing good hygiene, or choose to serve in a more direct way, we applaud everyone’s efforts to stop the spread of COVID-19 in our community.

The NIH is deeply concerned for the health and safety of people involved in NIH research, and about the effects on the biomedical enterprise in the areas affected by the HHS declared public health emergency for COVID-19. This is a rapidly evolving situation, and we are aware that many institutions are taking a variety of “social distancing” measures, including switching to telework and cancelling or postponing classes and non-essential meetings. 

• District of Columbia  
• Maryland Commerce
• Maryland Business Express   
• Virginia
• US SBA  

Volunteers

There have been concerns about possible shortages of hospital beds and protective gear during the COVID-19 pandemic, but the biggest concern in Maryland may be not having enough medical workers.

“Staffing might be more of a constraint than beds and supportive equipment,” said Bob Atlas, president and CEO of the Maryland Hospital Association. The group represents all of the state’s hospitals.

Concerns about SARS-CoV-2 infection have reached an all-time high in the United States and around the globe. With increasing numbers of COVID-19 cases, hospitalizations, and deaths—and “social distancing” now a household word—the possibility of being infected is on everyone’s mind.

As if that weren’t enough to worry about, the surfacing of multiple personal accounts—primarily out of China and Japan—of patients who recovered after infection only to fall ill a second time, have some worried about the possibility of reinfection.

Heather Phillips was supposed to be getting ready to join her extended family at its annual pumpkin carving celebration in Clarksburg, but instead she was still at work at Lung Bioengineering in downtown Silver Spring. It was late on a Saturday morning in October, and she’d been working all night. Now she stood inside the loading dock of the two-story building awaiting, for the third time in 12 hours, the delivery of an insulated cardboard box filled with ice and a pair of human lungs.

Image: Specialists Sam Popa (left) and Erin Larrabee prepare a set of lungs in a Lung Bioengineering operating room. Photo by Lisa Helfert

VICTORIA, British Columbia--(BUSINESS WIRE)--

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced that the Company has established its U.S. commercial center of operations in Rockville, Maryland. The new site will support Aurinia’s plans for growth as it prepares for the potential approval and launch of voclosporin for the treatment of lupus nephritis in 2021.

ROCKVILLE, Md.--(BUSINESS WIRE)--Immunomic Therapeutics, Inc., a privately held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its First-In-Human (FIH) Phase I trial and development plans for ITI-1001. The FDA addressed the Company’s questions and provided feedback on key components of the planned IND application for the candidate, ITI-1001, for the treatment of newly diagnosed Glioblastoma Multiforme (GBM).