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The new rules come out of the recent public health emergency declaration, building on others announced in late March and early April. This round of changes, which take effect immediately, focuses on expanding testing capacity to help reopen the U.S. economy, according to CMS, along with delivering expanded care to seniors.

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Digital RESI June 2020 Innovation Challenge Finalists Announced Next Phase Newsletter

Our 3-day Digital RESI June Conference is coming up in less than 3 weeks, and we are very excited to announce our Innovation Challenge finalists. With a diverse representation across therapeutics, medical devices, diagnostics, and digital health, these companies were selected on the basis of innovative technology, strong management team, clear pathway to commercialization, and other positive factors that demonstrated high growth potential.

 

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FREDERICK, Md. – Frederick County Executive Jan Gardner today announced the launch of a new grant program to support local small businesses and farmers. She earmarked $5 million to award through the new Jump Start Grants Program. Jump Start grants are designed to assist small for-profit businesses and nonprofit organizations that experienced financial loss caused by the coronavirus. The county’s Office of Economic Development will administer the program.

 

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Information about immunity to SARS-CoV-2, both in the context of COVID-19 disease pathogenesis and in the context of how to develop a good vaccine, remains limited. But developing a vaccine and predicting how the coronavirus pandemic will unfold until such a vaccine is available are both contingent upon the understanding of whether the immune system can mount a substantial and lasting response to SARS-CoV-2 and whether exposure to other, common, circulating coronaviruses provides any kind of protective immunity.

 

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Hundreds of thousands of small businesses that took Paycheck Protection loans finally have a path to getting their loans forgiven, but much delayed guidance released by the federal government is nowhere near final.

On Friday, the U.S. Treasury and Small Business Administration released an 11-page loan forgiveness application with instructions on how to complete it. While the document clarifies a number of administrative queries, such as when, exactly, does the eight-week covered period begin, it fails to address several key issues. Those include whether bonuses can count as cash compensation, and how quickly forgiveness will work. The agencies also noted that the SBA would "soon" issue regulations and guidance to further assist borrowers and lenders. There's no timeline for this next release.

 

Adaptive Phage Therapeutics A New World of Treatment A New World of Treatment

Bacteriophages have long been used to treat infections. These naturally occurring virus are capable of killing bacteria, but each strain of phage is highly specific. Because of their unique mechanism of action, they provide a potential to address the growing threat posed by multidrug-resistant bacteria, but to treat someone, the right phage must be matched to each patient’s infection. Adaptive Phage Therapeutics believes it’s found a way to create phage therapies suited to treat patients with drug-resistant infections by building a bank of targeted and genomically-screened bacteriophage and testing individual patient’s bacterial colony against that to determine the appropriate phage to treat them. We spoke to Greg Merril, co-founder and CEO of Adaptive Phage Therapeutics, about the origins of the company, how its technology works, and the regulatory hurdles for producing customized therapies to treat individual patients.

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COLUMBIA, Md., May 4, 2020 (Newswire.com) – Intralytix, Inc. announced today that it has received a multimillion-dollar grant (AI 148054) from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), for the clinical development of its bacteriophage therapy preparation for managing infections caused by the bacterial pathogen Shigella. Dr. Alexander Sulakvelidze, Executive Vice President of Intralytix and the Program Director of the multi-PI grant, commented, “We are very pleased to have this collaborative opportunity with NIAID. The project will address a significant public health issue, as it is expected to help reduce the burden of disease caused by Shigella. It will also help enhance our program on developing bacteriophage-based therapeutic preparations as complementing modalities to other anti-infectives, such as vaccines and antibiotics, for managing bacterial diseases, including those caused by multi-drug resistant bacterial pathogens.” Dr. Sulakvelidze concluded, “This award paves the way for an important clinical study, and also shows that Intralytix continues to demonstrate innovative leadership in successfully developing bacteriophage products for various applications.”

 

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ROCKVILLE, Md.--(BUSINESS WIRE)--20/20 GeneSystems, Inc. announced today that it will offer in its CLIA laboratory a COVID-19 antibody test that received an Emergency Use Authorization (EUA) from the FDA on May 3. According to test manufacturer Roche Diagnostics, the blood test has a specificity greater than 99.8% and sensitivity of 100% (14‑days post-PCR confirmation) and is used to determine if a person has developed antibodies to SARS-CoV-2, the virus that causes COVID-19.

 

Elizabeth Cairns

Of all the venture funding flowing into the medtech industry, a lower proportion than ever is being invested in companies at the start-up stage, a new analysis by Evaluate Vantage shows. Less than 5% of venture cash has been put into seed funding and series A rounds so far this year.

This shifting of cash from early into later rounds is a continuation of a trend that has been clear for some time. What is somewhat unexpected, however, is the relative prominence of series D financings in 2020 so far. Granted, this year is hardly typical; perhaps the pressures of the pandemic have pushed investors to mid- as well as late-stage rounds.

 

Task Force Holds Kick Off Meeting Affirms Support for Regional Collaboration to Tackle the Pandemic

WASHINGTON, D.C., May 22, 2020 – Connected DMV’s COVID-19 Strategic Renewal Task Force held its kickoff meeting on Thursday and affirmed their support for regional collaboration to tackle the pandemic with the following statement:

“The COVID-19 health pandemic has reinforced the importance of regional collaboration and cooperation between the District, Maryland and Virginia. It is also a necessity, if we are to secure the long-term stability and vitality of the DMV, solidify our position as a hub of innovation and leadership, and instill confidence in all our residents – on the safest path forward. Together and inclusive of our diverse communities, we need to define how our region can best recover, emerge, and thrive after the most acute conditions of the pandemic have subsided. The Connected DMV Strategic Renewal Task Force is committed to that shared future. Every step we make together as a region will ensure a stronger future for the DMV.”

 

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)

The phase I trial in healthy adult volunteers began in April. More than 1,000 immunisations have been completed and follow-up is currently ongoing.

The next study will enrol up to 10,260 adults and children and will involve a number of partner institutions across the country.

The phase II part of the study involves expanding the age range of people the vaccine is assessed in, to include a small number of older adults and children:

• Aged 56-69 • Aged over 70 • Aged between 5-12 years

 

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REUTERS: Oxford University and AstraZeneca are recruiting around 10,000 adults and children in Britain for trials of an experimental coronavirus vaccine, a day after receiving US backing worth up to US$1.2 billion.

Institutions across Britain had begun enrolling up to 10,260 adults and children to see how well the human immune system responds to the vaccine and how safe it is, the university said.

 

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GAITHERSBURG, Md., May 25, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX‑CoV2373, a stable, prefusion protein made using its proprietary nanoparticle technology. NVX‑CoV2373 includes Novavax’ proprietary Matrix‑M™ adjuvant to enhance immune responses and stimulate high levels of neutralizing antibodies. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.

 

WASHINGTON - (May 21,2020) -- Children's National Hospital is establishing a regional pediatric telehealth consortium in response to coronavirus with $928,000 in funding awarded by the Federal Communications Commission's Wireline Competition Bureau. The funding, which is part of the FCC's COVID-19 Telehealth Program, enables the nationally-ranked pediatric hospital to expand its telehealth platform to support 15 healthcare sites in the D.C.-Maryland-Virginia region serving children and young adults, providing care to children with COVID-19 as well as those who are medically vulnerable and helping to protect healthcare workers as the pandemic threat continues.

 

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ROCKVILLE, Md., May 26, 2020 /PRNewswire/ -- Emmes today announced that its data and statistical analysis work for the Adaptive COVID-19 Treatment Trial (ACTT) played an important role in the accelerated timetable to evaluate remdesivir's effectiveness in treating hospitalized COVID-19 patients. 

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, sponsored the clinical trial, which included 1,063 participants at 60 sites in 10 countries. Emmes has a long history in supporting NIAID's Division of Microbiology and Infectious Diseases and has served as a Statistical and Data Coordinating Center for more than 350 of its clinical trials since 1998.