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Anti-Vaccination Activists Join Stay-At-Home Order Protesters

Among those rallying against state shutdown orders are anti-vaccination activists. They see these protests as a way to form political alliances that promote their movement.




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So, You're Not Talking Much In Quarantine. Here's How To Keep Your Voice Healthy

With social distancing, many people are speaking less and their voices sound raggedy. NPR's Scott Simon talks with speech pathologist Sandy Hirsch, about keeping the voice sounding as it should.




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Tracking The Pandemic: How Quickly Is The Coronavirus Spreading State By State?

View our map and graphics to see where COVID-19 is hitting hardest in the U.S., which state outbreaks are growing the fastest and which are leveling off.




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Day Three Notes – JP Morgan Healthcare Conference, San Francisco

Yesterday’s conference sessions surfaced interesting questions and approaches regarding the post-acute sector, bundled payment, emergency medicine and anesthesia. Post-Acute Focus: With more and more focus on the need to rationalize and re-organize the post-acute sector, we have seen multiple industry leaders start to evolve their strategies.  I blogged yesterday about AccentCare’s interesting strategy in the...… Continue Reading




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Extending the Patentable Life of 3D Printers: A Lesson From the Pharmaceutical Industry

Modern innovation typically occurs one step-improvement at a time. Some clients initially question whether their new application of an existing technology is patentable. Usually, the answer is ‘yes.’ Under U.S. law (and most other jurisdictions), an innovation to an existing technology is patentable so long as at least one claim limitation is novel and non-obvious....… Continue Reading




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PTO Cancer Immunotherapy Fast Track

In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications related to cancer immunotherapy and is set to launch in July 2016. According to the USPTO, this initiative: aims to cut the time it takes to...… Continue Reading




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Looking Forward/Looking Backward – Day 1 Notes from the JPMorgan Healthcare Conference

A large amount of wind, much discussion about the U.S healthcare, and the public getting soaked again – if you were thinking about Washington, DC and the new Congress, you’re 3,000 miles away from the action. This is the week of the annual JP Morgan Healthcare conference in San Francisco, with many thousands of healthcare...… Continue Reading




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Food for Thought (and Health): Day 2 Notes from the JP Morgan Healthcare Conference

Addressing the Social Determinants of Health:  Is the healthcare industry pushing a rock up a hill?  We collectively are trying to provide healthcare with improved quality and reduced cost, but the structure of the nation’s healthcare system remains heavily siloed with the social determinants of health often falling wholly or partly outside the mandate and...… Continue Reading




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The Old and the New – Day 3 Notes from the JPMorgan Healthcare Conference

Day 3 of the JPMorgan healthcare conference was one of striking contrasts between the old and the new. (And, by the way, the rain finally stopped for a day, but it will be back tomorrow to finish off the last day of the conference). The Old:  Sitting in the Community Health Systems (CHS) presentation and...… Continue Reading




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Notes on Day 4 of the JPMorgan Healthcare Conference

Some interesting presentations on the last day of the JPMorgan Healthcare Conference that concentrated on common themes – the increasing importance of ancillary business line to bolster core business revenue and of filling in holes to achieve scale and full-service offerings. Genesis Healthcare – The largest U.S. skilled nursing facility (SNF) provider, which also is...… Continue Reading




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WannaCry Ransomware Alert

This is not a drill. Companies and law enforcement agencies around the world have been left scrambling after the world’s most prolific ransomware attack hit over 500,000 computers in 150 countries over a span of only 4 days. The ransomware – called WannaCry, WCry, WannaCrypt, or WannaDecryptor – infects vulnerable computers and encrypts all of...… Continue Reading




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Can pharma become a digital industry?



  • in the news
  • Working in the industry
  • Pharma Digital Transformations

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Gilead games the system




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A vaccine probably won’t arrive any time soon.




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The MDCG cybersecurity guidance – a helpful rush job

It has been some time since the MDCG guidance on cybersecurity for medical devices was released (MDCG 2019-16 December 2019), so everybody has probably had the opportunity to get used to the document by now. While the document is by no means ideal or even flawless (congratulations MDCG on a glaring spelling mistake in the […]




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New MDCG Class I Article 120 (3) and (4) MDR guidance – nothing new but nice summary of requirements

I have blogged before about the effects and possibilities of the Corrigendum of December 2019 for class I medical devices. I refer you to that blog for the background to this discussion, which covers the mechanics of timing. The draft corrigendum discussed in that blog was adopted as described.  The new guidance The MDCG has […]




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Commission working on proposal to postpone MDR date of application for one year

After a statement on a press conference today by Stefan De keersmaecker that had many people very excited quickly, the official announcement came later in the afternoon: Here is what I think about this development. Work on a proposal ongoing The Commission announced that ‘work on a proposal to postpone the date of application’. This tells […]




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The MDR amendment proposal: more than meets the eye

On Friday 3 April 2020 it finally happened: the Commission proposal for amendment of the MDR to defer the date of application with a year that everyone was waiting for and was in the works for some time was finally published. As I have heard from many directions immediately after the announcement of the proposal being […]




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MDR amendment proposal article 120 (3) oversight set to be fixed by Council

It’s always a risk to put out a theory about legislative oversight after a Sherlock Homes investigation that eliminates all other options as I did in my last blog about the MDR amendment proposal. Recent development seem to confirm that I was right in assuming that not touching the two dates of application of 26 […]




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New MDCG guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions

When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]




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MDR date of application move: politically a done deal now

With the overwhelming vote in the Parliament in favor of the Commission proposal to amend the MDR it is politically basically a done deal now that the MDR will be amended. After the vote there were people that immediately stated that the amendment was formally approved – not so. We are looking at law making […]




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Andy Serkis (and maybe Gollum?) will read 'The Hobbit' for coronavirus charities

Andy Serkis, who plays Gollum in the "Lord of the Rings" films, announced that he will livestream a reading of J.R.R. Tolkien's "The Hobbit" on Friday.




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The Check-In: Justin Turner unsettled at thought of not playing again for the Dodgers

The Dodgers' Justin Turner and his wife Kourtney have delivered more than 500,000 meals to the needy since March. He'll be a free agent this winter.




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Newsom unveils rules governing how quickly California communities can reopen businesses

Newsom said earlier this week that bookstores, florists and others can reopen for curbside pickup Friday, unless barred by tougher local restrictions.




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Drive-through celebrations and car parades nixed in Santa Clara County

The coronavirus outbreak has forced the cancellation of myriad life events. Santa Clara County won't even let you celebrate in your car now.




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Even if you want to buy a home, it's harder now to get a loan. Or tap home equity

As the economy has cratered, mortgage lenders tightened standards for people who are still interested in buying or refinancing a home.




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U.N. nearly triples its coronavirus fundraising goal to $6.7 billion

The U.N. triples its fundraising target for fighting the coronavirus, even as President Trump plans to freeze U.S. aid to its principal health agency.




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California to reopen 25 DMV field offices on Friday after they were shut down amid coronavirus

California DMV will reopen 25 field offices after shutdown




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138 employees at Central California meat plant test positive for coronavirus

Kings County Supervisor Doug Verboon said the outbreak at Central Valley Meat Company in Hanford accounts for nearly two-thirds of the coronavirus cases in the rural county, which has a total of 211 reported cases.




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Here are the Orange County communities with coronavirus cases

Orange County reported one additional coronavirus-linked fatality Thursday, bringing the region's total death toll to 66.




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Editorial: California was ready for a recession, but nothing could have prepared it for coronavirus

The good news: The state is far better prepared to meet this challenge than it was a decade ago. The bad news: It will need help from the feds, and a lot of it.




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San Francisco will allow certain businesses to reopen beginning May 18

San Francisco will allow certain businesses to reopen beginning May 18 as it eases its stay-at-home orders. But officials warn that they will keep track to make coronavirus infections don't spike.




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Gov. Newsom doesn't see packed stadiums for sporting events anytime soon

California Gov. Gavin Newsom says he doesn't see full stadiums of fans for sports happening amid the coronavirus outbreak until a vaccine is available.




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Judge grants request to delay start of prison sentence for former Rep. Duncan Hunter

A federal judge found that the uncertainty surrounding the COVID-19 pandemic was good cause for the delay.




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Protesters stage illegal rally at California Capitol to support law enforcement

Protesters of California's stay-at-home orders returned for another unsanctioned rally Thursday, telling law enforcement officers they are forgiven for arresting them last week.




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First Californian to get coronavirus in community spread was infected at a nail salon, Newsom says

Newsom cited the case when asked why personal services, such as nail salons, must remain closed.




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Coronavirus unemployment: WME cuts 20% of its workforce

Beverly Hills-based William Morris Endeavor said it is reducing its workforce by 20% through furloughs, layoffs and moving people to part-time employees.




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Souplantation's buffet-style restaurants closing for good because of the coronavirus

Souplantation's owner says there was no way the restaurants' longtime self-serve model could survive in the era of COVID-19




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Unemployment hits 14.7% in April. How long before 20.5 million lost jobs come back?

Analysts say steep jump in unemployment and layoffs caused by the pandemic will be hard to reverse quickly.




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Letters to the Editor: Mr. President, protect us with testing. Then we'll be your coronavirus 'warriors'

Trump admits that he's putting Americans at grave risk by encouraging economices to reopen. He should protect us with testing.




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Op-Ed: I see face masks as a socially acceptable fashion opportunity. So should you

Building a wardrobe of fashionable face masks doesn't make me insensitive to the grave consequences of coronavirus.




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How to get legally married during the coronavirus crisis

Marriage, like many aspects of life, has changed. Here's what you need to know about getting a license and the rest of a process that was already complicated.




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Fears of a second coronavirus surge haunt California as it begins slow-speed reopening of economy

Reopening California begins -- but very slowly, cautiously and under the shadow of a second wave.




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An Orange County cafe opened in defiance of Newsom. Now it's the center of stay-at-home resistance

When it opened last week for the first time since mid-March, Nomads Canteen in San Clemente quickly filled with customers eager to get out of the house and return to some sense of normalcy amid the COVID-19 pandemic.




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Someday we'll return to the office. It'll be nothing like we've seen before

With no coronavirus vaccine in sight, employers and building landlords are turning to tech, design and distancing to keep office workers healthy.




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Column: The cruise ship industry is sinking. I'm OK with that

Norwegian Cruise Line says it's in danger of going out of business. Maybe that's not the worst thing for an industry of floating petri dishes.




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At protests, mostly white crowds show how pandemic has widened racial and political divisions

Coronavirus pandemic widens racial and political divisions




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Mystery syndrome similar to Kawasaki disease linked to coronavirus at Children's Hospital Los Angeles

Doctors have recently identified a condition called pediatric inflammatory multi-system syndrome among children who have tested positive for antibodies against COVID-19.




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Season Interrupted: Middlebury-bound Riley Griffis can hang in the deep end

Loyola swimming star Riley Griffis quickly read the reality of life outside the pool: 'The time away has shown it's something I need to function."




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L.A. Phil's 100th birthday bash: Your quarantine must-watch of the day

It was one of last year's hot tickets: Gustavo Dudamel, Esa-Pekka Salonen and Zubin Mehta, on the same stage at the same time. How to see it for free.