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Missing Major League Baseball? Here's Korean baseball to the rescue

While much of the world is under lockdown, baseball returned to South Korea on a day when the country reported just three new cases of COVID-19.




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Hospitals prepare for wave of mental health disorders among their workers

As many as 20% to 25% of healthcare workers in hard-hit areas, experts say, are likely to develop disorders such as anxiety, depression or post-traumatic stress.




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Column: The U.S. and China are sliding into a Cold War nobody needs

The coronavirus is pitching the U.S. and China into a new Cold War -- a confrontation over ideology as well as trade and security. It's happening partly because President Trump needs an issue to run on -- and it's dangerous




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Trump calls Americans 'warriors' in fight to open the economy

As COVID-19 deaths keep rising, Trump's message has shifted from 'one is too many' to praising Americans as warriors fighting to open the economy.




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'We're vulnerable': On the Navajo Nation, a rush to curb the coronavirus

A desperate attempt to halt coronavirus cases is underway on the country's largest reservation, which spans Arizona, New Mexico and Utah.




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He fought to protect sex workers from COVID-19 and much more. Then the virus came for him

For decades, Jaime Montejo fought to bring dignity to sex workers in Mexico City, protecting them from police, pimps and eventually the coronavirus. Then he got sick.




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Commentary: Evaluating risk and medical treatment in the time of coronavirus

Risk guides much of our medical care system. COVID-19 is showing us, unless we have developed immunity, we are all at risk.




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A coronavirus debate on the apple orchard: Should migrant workers be allowed to sleep in bunk beds?

Washington state fruit growers say that a ban on bunk beds in farmworker housing would cut their seasonal work force in half, likely leading to food shortages and price hikes.




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Moms in California may need parasols while moms in the East need parkas this weekend

Mother's Day weekend will be summery in California and wintery with snow in parts of the East




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In Brunswick, Georgia, residents reflect on the shooting of Ahmaud Arbery

For many Americans, Arbery's killing harks back to the old Jim Crow days when white mobs hunted black men down and killed them with impunity. In Brunswick, the shooting has sparked an uneasy conversation about race and power.




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The warehouses where goods are piling up

Shops and restaurants are selling less, but goods are still arriving at warehouses around the UK.




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The groundbreaking way to search lungs for signs of Covid-19

Artificial intelligence technology is being rapidly deployed worldwide to help tackle Covid-19.




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Coronavirus: How African firms are being impacted by the lockdown

With imports slowing, many African nations are learning the importance of local manufacturing.




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The firm switching from floor tiles to surgical masks

Switching products to suit the times: the floor tile manufacturer now making masks for the NHS.




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Coronavirus bailouts: Which country has the most generous deal?

A look at the different ways nations are trying to cushion the blow from the virus shutdowns.




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How Waterstones is selling books during the coronavirus lockdown

Waterstones CEO: How I keep selling books while my bookshops are shut down.




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International star Irrfan Khan has died at the age of 53

Stars from around the world have been paying tribute to actor Irrfan Khan who has died at the age of 53.




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The Last Dance: 'I did not anticipate this reaction'

Jason Hehir speaks to the BBC about interviewing Michael Jordan and why the documentary series has had such an impact.




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VE Day: The story behind Vera Lynn's We'll Meet Again

The song encapsulated the sadness and determination felt by families separated during WW2.




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Ahmaud Arbery Murder Suspects Face the Judge, No Bond

5/8 -- Arbery's murder suspects just went before the judge via video conference to face their charges. However, a Glynn County Magistrate clerk says that Gregory and Travis McMichael were denied bond today during their initial hearing due to the…




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Mother's Little Mini-Mes -- Take Two!

It might be all about moms this weekend, but it seems like we need to make some room for the next generation to shine too! These mamas have been sharing some sweet snaps of their matching moments with their babes ... and these cuties might just be…




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Queens of the Stone Age Singer Josh Homme Gets Restraining Order

Queens of the Stone Age front man Josh Homme is flipping the script on his estranged wife, whom he claims has been trying to get him busted for allegedly violating a restraining order. Now the rock singer's filed for a restraining order against…




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What's The Big Frigin' Difference?

Do not let these two almost identical images of Kelly Osbourne start making you feel confused ... just take a deep breath and get a really good look around to see if you can find the sneaky switches that have been made to this tricky pic! Osbourne…




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Stars and Scars -- You Be the Judge

The brutal killing of Ahmaud Arbery is gut-wrenching and outrageous. And, the virus is causing many to choose between financial and physical health. So we gotta ask ...




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The Voice contestants team up for NHS song after coronavirus stopped live shows

The show was postponed last month because of the COVID-19 pandemic




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Helen Flanagan rescued after breaking down on the motorway while delivering PPE

The Coronation Street star is a volunteer during the coronavirus crisis




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Former Love Island contestant says she's 'glad' the show has been cancelled

Mental health advocate Malin Andersson reacted to the news that the ITV2 dating show has been shelved




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4 Tech Trends for the New Hotel Age

For businesses serving the hospitality sector, growth relies on implementing and capitalizing modernized systems to improve processes and increase guest satisfaction. These are the four most important strategies to achieve this goal in 2020.

Keep on reading: 4 Tech Trends for the New Hotel Age




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The Enterprise 2020 Report: Software CEO Briefing

At the annual invite-only 2020 Enterprise Retreat in Half Moon Bay, CA, 100 enterprise leaders gathered in a social-media free environment, to network, discuss hot topics and dive into provocative, insightful off-the-record 'State of the Union' presentations. This report details their findings.

Keep on reading: The Enterprise 2020 Report: Software CEO Briefing




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Proceedings of the National Academy of Sciences




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Google Cloud vs. AWS: Who Has The Best Pricing?

When evaluating public cloud providers on pricing, it is easy to get hung up on the differences. AWS and Google Cloud each have their own service catalog, terminology and purchasing variations. But do these differences actually impact the final bill?

Keep on reading: Google Cloud vs. AWS: Who Has The Best Pricing?




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Automating the Cloud: AWS Tools and Tips

Sharing third-party AWS workflow options that can be integrated to increase your operation's effectiveness and productivity when working in the cloud. 

Keep on reading: Automating the Cloud: AWS Tools and Tips




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FDA AMENDS THE DEFINITION OF “BIOLOGICAL PRODUCT” AND PREPARES FOR THE CONCLUSION OF A DECADE-LONG TRANSITION PERIOD

By Jennifer A. Davidson and Justine E. Johnson On February 21, 2020, FDA published a final rule that, effective March 23, 2020, amends the regulatory definition of “biological product” consistent with the statutory definition under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as amended by the Further Consolidated Appropriations Act, 2020 (FCAA),

The post FDA AMENDS THE DEFINITION OF “BIOLOGICAL PRODUCT” AND PREPARES FOR THE CONCLUSION OF A DECADE-LONG TRANSITION PERIOD appeared first on Kleinfeld Kaplan & Becker LLP.




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Shortage of PPE and other Devices During COVID-19 Pandemic – Is 3D Printing the Answer?

By: Suzan Onel FDA issued a Press Release on March 28, 2020, reiterating what we all have seen in the news, there is a severe shortage of personal protective equipment (PPE) in health care facilities across the country.  In response to the shortages, FDA has issued Emergency Use Authorizations (EUAs) for respirators, ventilators, ventilator tubing

The post Shortage of PPE and other Devices During COVID-19 Pandemic – Is 3D Printing the Answer? appeared first on Kleinfeld Kaplan & Becker LLP.




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New Opportunities for OTC Monograph Drugs under the CARES Act

By: Daniel Dwyer and Daniel Logan On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. Law 116-136), which includes a comprehensive revision of the rules governing over-the-counter (OTC) drugs currently marketed under monographs published by the Food and Drug Administration (FDA).  This law

The post New Opportunities for OTC Monograph Drugs under the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.




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Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act

By: Daniel Logan and Justine Johnson The Coronavirus Aid, Relief, and Economic Security Act, or “CARES” Act (Pub. L. No. 116–136) makes numerous changes to the Federal Food, Drug, and Cosmetic Act (FDCA).  The CARES Act made substantial changes related to the regulation of over-the-counter (OTC) drugs (see KKB’s alert here dedicated to summarizing these

The post Changes Made to the Federal Food, Drug, and Cosmetic Act by the CARES Act appeared first on Kleinfeld Kaplan & Becker LLP.




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LIVE WEBINAR: Hemp & CBD: FDA Update and the Impact of COVID-19

Join Kleinfeld, Kaplan & Becker, LLP and Vicente Sederberg on Tuesday, April 7 at 2:15 p.m. ET for a live webinar on Hemp and CBD – FDA Update and the Impact of COVID-19. Since 2015, KKB and VS have worked closely together in advising clients on the ever-evolving legal landscape for hemp-derived products. During this

The post LIVE WEBINAR: Hemp & CBD: FDA Update and the Impact of COVID-19 appeared first on Kleinfeld Kaplan & Becker LLP.




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KLEINFELD, KAPLAN & BECKER WELL REPRESENTED ON THE WASHINGTON, DC, 2020 SUPER LAWYERS LIST FOR “FOOD AND DRUGS”

We are pleased to announce that KKB partners Dan Dwyer, Stacy Ehrlich, Peter Mathers, and Suzan Onel were selected for the annual Super Lawyers list for Washington, DC.  They make up more than 20% of the 18 DC attorneys listed in the “Food and Drugs” category.  In addition, for the sixth year in a row, KKB

The post KLEINFELD, KAPLAN & BECKER WELL REPRESENTED ON THE WASHINGTON, DC, 2020 SUPER LAWYERS LIST FOR “FOOD AND DRUGS” appeared first on Kleinfeld Kaplan & Becker LLP.




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Potential of Ayurveda should not be ignored in the fight against COVID─19: Dr Saravadekar




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PPE suppliers providing unauthentic certificates to buyers including govt procurement agencies




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Maharashtra FDA allays fears of shortage of HCQ tabs either in govt hospital pharmacies or in retail pharmacies




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AIOCD urges govt to provide insurance cover to chemists to strengthen fight against COVID─19




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Supersaturated Oxygen Therapy Cleared in EU to Treat Widowmaker Heart Attacks

ZOLL Medical, a part of the Asahi Kasei Group, won EU clearance for its SuperSaturated Oxygen (SSO2) Therapy System to be used to minimize the damage that heart attacks cause within heart muscle. Approved about a year ago in the United States, SSO2 is the only option beyond percutaneous coronary intervention (stenting) that can help […]




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How Compounding Solutions are meeting the demand for medical materials during Covid-19

Since early February, custom material solutions provider, Compounding Solutions, has been working hard to meet material demands related to Covid-19.




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The force: How to improve ultrasonic plastic welding

Tom Hoover, senior medical business development manager – Americas, assembly technologies, at global technology and manufacturing company, Emerson, explains how ultrasonic plastic welding is improved through improved force control.




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How a custom plastic injection moulder is coping with the rise in demand due to Covid-19

Diversified Plastics (DPI), a custom plastic injection moulder and additive manufacturer of high-precision components, has increased the capacity of its Acceleration Station to meet the rise in demand associated with the Covid-19 pandemic.




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EU MDR delayed: How does this impact the industry?

Maurits Lugard, a partner, Josefine Sommer, a senior associate, and Anouchka Hoffman, an associate, at Sidley Austin, examines the consequences that come with the delay of the application of EU Medical Devices Regulation by one year.




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Survey suggests manufacturers need more support from the government

Small to medium-sized (SME) manufacturers are calling for greater and faster financial support from the government as they confront plummeting sales, production volumes, and the prospect of job cuts amid the ongoing Covid-19 pandemic.




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Support terminated for four devices in the Ventilator Challenge

The UK government has announced it will be ending support for four devices in the Ventilator Challenge.




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How Covid-19 is impacting the medtech industry

Munich-based software start-up Climedo Health has published a whitepaper assessing the "Impact of Covid-19 on the medtech industry".