Risks and Implications of Post Hoc Changes to the Borrower Certification Requirements What PPP Borrowers Need to Know Insights Venable LLP

Since the enactment of the CARES Act, the Small Business Administration and U.S. Department of the Treasury have continually updated the rules governing the Paycheck Protection Program (PPP) through formal rulemaking and less formal guidance. In some cases, these rules and guidance have contradicted the plain language of the Act itself.

The PPP, of course, is designed to provide businesses and nonprofits with 500 or fewer employees (subject to certain notable exceptions) access to 2 months of payroll for their employees in light of the economic uncertainty brought on by the COVID-19 Pandemic.

 

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The National Institutes of Health today announced a new initiative aimed at speeding innovation, development and commercialization of COVID-19 testing technologies, a pivotal component needed to return to normal during this unprecedented global pandemic. With a $1.5 billion investment from federal stimulus funding, the newly launched Rapid Acceleration of Diagnostics (RADx) initiative will infuse funding into early innovative technologies to speed development of rapid and widely accessible COVID-19 testing. At the same time, NIH will seek opportunities to move more advanced diagnostic technologies swiftly through the development pipeline toward commercialization and broad availability. NIH will work closely with the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the Biomedical Advanced Research and Development Authority (BARDA) to advance these goals.

Image: https://www.nibib.nih.gov

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)

Gilead Sciences’ closely-watched COVID-19 drug candidate remdesivir outperformed placebo in a clinical trial sponsored by the NIH’s National Institute of Allergy and Infectious Disease (NIAID), the agency announced today—the first clinical study launched in the U.S. of a therapeutic for the virus.

NIAID released preliminary data showing that the study met its primary outcome of statistically significant improvement in time to recovery by Day 29. Patients who were treated with remdesivir showed a median time to recovery of 11 days compared with 15 days for those who received placebo—a 31% faster time to recovery.

 

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Gilson and QIAGEN have entered into a strategic partnership that will provide researchers the ability to limit operator-dependent variation in their manual nucleic acid extraction results and improve the traceability of their workflows.

This agreement brings together two influential leaders in the life science industries: Gilson, a global manufacturer of sample preparation technology, and QIAGEN, a leading global provider of molecular diagnostics and sample preparation technologies.

This collaboration will integrate Gilson’s TRACKMAN® Connected digital bench tools and QIAGEN’s manual nucleic acid extraction kits to create consistency between collaborators, increase confidence in their execution of extraction protocols, and improve traceability at the bench.

 

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Personal Genome Diagnostics, the venture-backed developer of a novel diagnostic kit for genomic profiling of different cancers in lab settings, has received clearance from the U.S. Food and Drug Administration for its PGDx elio tissue complete test.

The test’s approval is another step forward for precision therapies that rely on an understanding of the unique genomic profile of an individual patient’s tumor, according to the company.

Image: Image Credits: Ed Uthman / Flickr (opens in a new window)under a CC BY 2.0 license.

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BALTIMORE--(BUSINESS WIRE)--Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, announced today that the company has received market clearance from the U.S. Food and Drug Administration (FDA) for PGDx elio™ tissue complete, a comprehensive diagnostic kit that can be used by molecular laboratories to perform genomic profiling of cancer in a more efficient, reliable, and accurate manner. By automating the data analysis process, which is incorporated in the cleared product, PGDx is enabling the scalability of precision medicine in healthcare systems across the country.

 

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BALTIMORE, Md., April 27, 2020 /PRNewswire/ -- LifeSprout, a privately-held regenerative medicine company founded with technology licensed from Johns Hopkins University, has closed a $28.5 million Series A financing. The company is using proceeds to support clinical development of novel therapeutic products from its Regenerative Matrix platform.

The financing was led by Redmile Group, LLC, with new institutional investors Nexus Management, LP, Emerald Development Managers, LP, and the Abell Foundation joining the syndicate.

"We are delighted to complement the lead investment from Redmile with a strong cadre of Maryland-based and international investors," stated Sashank Reddy, MD, PhD, co-founder of LifeSprout. "The early, visionary investments made by the Maryland Stem Cell Research Fund and others made this new financing possible."

 

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Gentian AS, a Norwegian company, with its US office at BioHealth Innovation in Rockville, Maryland is seeking collaborators to investigate if two of the biomarkers in their portfolio, cystatin C (FDA510(k) cleared) and plasma calprotectin (US research only), could potentially be useful for detection of the severely affected COVID-19 patients.

High mortality and long hospitalization are consequences of the severe cases with COVID-19 pneumonia. Gentian therefore believes that it is important to identify biomarkers that can aid in early, rapid and effective identification of the severely affected patients.

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Alexandria LaunchLabs™ in Maryland, will provide fully equipped, affordable laboratory/office space with flexible lease terms, supporting infrastructure, access to amenities, and supporting services and programming through the project’s consortium of world-class partners, including Alexandria Venture Investments, BioHealth Innovation, Montgomery County, and the City of Gaithersburg. This unique, startup environment will accelerate the growth of local early-stage life science companies.

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FDA Cleared Medical Device Improves Feeding Outcomes of Infants Born Prematurely

Olathe, KS and Rockville, MD, April 28, 2020—Innara Health, developer of the only FDA cleared medical device designed to improve the feeding outcomes of infants born prematurely, is partnering with BioHealth Innovation (BHI) to support the company’s plans for growth through greater market access and the development of NextGen technology.  Innara Health is dedicated to improving feeding outcomes for newborn and infants born prematurely.  “As we continue to expand our domestic footprint, we are very fortunate to call BHI our partner as their infrastructure and access will certainly support Innara in our journey to redesign the NTrainer, enter into adjacent markets, and expand globally” states Innara CEO Chris Mathia.  “We are excited to support Chris and his team as they expand, grow and develop new technology ultimately enabling many more NICU patients to return home to their families sooner and healthier” said BHI CEO Rich Bendis.

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ANNAPOLIS, MD—After weeks of consulting with leading scientists, business leaders, and public health experts, Governor Larry Hogan today introduced the ‘Maryland Strong: Roadmap to Recovery,’ which provides a safe, effective, and gradual approach to reopening the state as it continues to combat the COVID-19 pandemic.

“As we begin to reopen, it will continue to be important for Marylanders, particularly older and more vulnerable Marylanders, to continue to stay home as much as they can,” said Governor Hogan. “All Marylanders should continue to avoid crowds and gatherings, and they should continue to practice physical distancing and to take precautions to protect themselves, their families, and their fellow Marylanders. Together, we are going to defeat this virus, and together, the State of Maryland will return stronger and better than ever.”

Image: https://governor.maryland.gov

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Maryland Gov. Larry Hogan on Friday announced his three-phase plan to eventually reopen the state amid the coronavirus pandemic.

Hogan called the plan a “well-thought-out, gradual, safe and effective path forward,” supported by four pillars he has spoken about often in recent weeks: increases in testing, personal protective equipment, contact tracing and hospital surge capacity.

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Working as an emergency and critical care physician at the University of Maryland School of Medicine, Dr. Steven Tropello is seeing the lack of protective equipment for medical workers up close.

One particular area is during a procedure in which a tube is inserted into a patient’s airway, called intubation. It’s necessary to place someone on a ventilator, but presents danger of spreading the new coronavirus through the air or touch to doctors if they lack protection.

Image: CareCove. (Courtesy photo)

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Emergex Vaccines Holding Limited (‘Emergex’), a biotechnology company developing CD8+ priming set-point vaccines to prevent serious infectious diseases, today announced that it has entered into an agreement with the George Mason University, based in Virginia, in the United States.

The agreement specifies that George Mason University’s National Center for Biodefense and Infectious Diseases will provide their unique expertise and resources as a partner in the development of Emergex’s vaccines against highly pathogenic RNA viruses. In particular, George Mason University’s Biosafety 3 capabilities, coupled with their experience in dealing with RNA viruses, means that they are a well-suited collaborator on the vaccine validation studies, as well as the optimization of vaccine design.

 

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A Baltimore company will be at the forefront of producing a potential coronavirus vaccine.

Once a COVID-19 vaccine is ready for mass production, the company is going to be making hundreds of millions of them.

"We'll be providing the drug substance manufacturing which is essentially the vaccine itself," says Syed Husain, senior vice president of Emergent BioSolutions.

All of that work will happen at Emergent BioSolutions, which is located in front of Johns Hopkins Bayview.