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FDA and FTC Send Joint Warning Letters to Seven Companies for “Selling Fraudulent COVID-19 Products” | Wilson Sonsini Goodrich & Rosati – JDSupra

By News Archive

Stop Road Sign Warning Free vector graphic on Pixabay

The number of cases of SARS-CoV-2 coronavirus infection, and COVID-19, the disease caused by the virus, continue to increase in the United States—both in number and in location (real-time map). At the same time, the number and severity of symptoms post-infection can vary by age and other risk factors (CDC Report). High level officials and politicians have been reported to be infected by, or in contact with, the virus. And there is no U.S. Food and Drug Administration (FDA) approved or licensed cure for COVID-19 (other than time, supportive measures as necessary, and a healthy immune system). “Although there are investigational COVID-19 vaccines and treatments under development, these investigational products are in the early stages of product development and have not yet been fully tested for safety or effectiveness.”

 

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University of Maryland athletics announces spectator restrictions amid coronavirus outbreak – Baltimore Sun

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University of Maryland athletics on Wednesday announced a series of safety measures for its home events amid concern over the coronavirus outbreak, now labeled a pandemic by the World Health Organization.

Among several changes announced in a release, “Effective immediately, only student-athletes, coaches, essential personnel, officials, credentialed media and a limited number of family members of the competing teams will be permitted to attend games, until at least April 10.”

 

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All you need to know about TBS Osteo – Medimaps

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All TBS Osteo features and main arguments. Included, in greater detail.

  • What is TBS Osteo powered by TBS iNsight and what is TBS (Trabecular Bone Score): the main arguments. 
  • TBS Osteo compatibilities with different DXA systems. 
  • Main evidence of TBS clinical validation. 
  • How TBS can be a significant aid to better characterize your patient’s risk profile. 
  • Short grid to understand the risk of fracture based on a combined model of TBS and BMD. 

Updated for TBS Osteo 3.1

 

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Jayson Derrick

Emergent Biosolutions, Inc. (NYSE:EBS), Novavax, Inc. (NASDAQ:NVAX) – Emergent BioSolutions CEO Talks Coronavirus Vaccine Development | Benzinga

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Jayson Derrick

Global life sciences company Emergent Biosolutions Inc EBS 6.61% CEO Bob Kramer said Thursday that his company’s partnership with Novavax, Inc. NVAX 6.3% could result in the creation of a therapy that poses a “fairly low risk.”

Emergent Has Past Experience With Anthrax, Botulism Emergent is using its own platform to help Novavax with the creation of a coronavirus vaccine, Kramer said during a guest appearance on CNBC’s “Squawk Box” segment Thursday morning. 

 

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Adaptive Phage Therapeutics A New World of Treatment

FDA Clears First Clinical Study for a Polymicrobial Phage Library-Based Treatment for Antibiotic-Resistant Infections | Business Wire

By News Archive

Adaptive Phage Therapeutics A New World of Treatment GAITHERSBURG, Md.–(BUSINESS WIRE)–Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of PhageBank™, a personalized bacteriophage therapeutic for the treatment of MDR and complicated bacterial infections. The Phase 1/2 trial represents the first study of an expanding phage library under FDA allowance for a multi-site study of intravenous administration and/or bladder instillation of phage therapy. Beginning in Q2, APT will enroll patients at up to three clinical sites for the evaluation of PhageBank for the treatment of complicated and chronic recurrent urinary tract infections (UTIs).

 

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Kristen Valdes

Baltimore health tech startup b. well Connect Health raises $16M – Baltimore Business Journal

By News Archive

Kristen Valdes

Baltimore health tech startup b. well Connected Health has raised a $16 million round as it looks to accelerate its growth.

The Series A round was led by UnityPoint Health Ventures, the venture capital arm of UnityPoint Health, an Iowa-based health system. Other investors include Wisconsin-based community health system ThedaCare and Well Ventures, a subsidiary of Walgreens Boots Alliance Inc., according to a release. The five-year-old company has previously raised $11.5 million in seed funding, bringing its total funding to over $27 million. In 2018, b. well also raised a total of $8.2 million in convertible debt funding from more than 60 investors.

 

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NIST Director Testifies Before House Science Subcommittee on Agency Reauthorization; Touts Success of the Manufacturing USA Program in Promoting Technology Transfer – ASME

By News Archive

NIST Logo

Last Wednesday, the House Science Committee, Subcommittee on Research and Technology, invited Under Secretary of Commerce and Director of the National Institute of Standards and Technology (NIST) Dr. Walter Copan to testify before the Subcommittee on reauthorizing the agency. NIST was last authorized in 2016 as part of the American Innovation and Competitiveness Act. Director Copan’s testimony covered each of the technologies the Trump Administration is collectively referring to as “industries of the future,” including Quantum Information Science, Artificial Intelligence, 5G, Advanced Manufacturing, and Biotechnology. He specifically commented on how NIST catalyzes partnerships between industry, academia, government, and other organizations to promote U.S. innovation and economic competitiveness.

 

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Johns Hopkins microbiologists develop coronavirus screening test

By News Archive

NewImage

BALTIMORE — Two Johns Hopkins microbiologists have developed an in-house coronavirus screening test that may soon allow the health system to test as many as 1,000 people per day.

Karen Carroll, M.D., and Heba Mostafa, M.B.B.Ch., Ph.D are the microbiologists leading this.

“We will be able to diagnose more cases. This will allow the control of exposure,” said Mostafa, assistant professor of pathology and director of the molecular virology laboratory at The Johns Hopkins Hospital.

Image: Photo by: Johns Hopkins Medicine

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