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

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

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

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

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

The MDCG just published a joint implementation plan regarding the MDR. Here is my summary and analysis. It’s not a happy story. Not the IVDR This implementation plan is not about the IVDR, and the fact that it is not about the IVDR is information in itself. It means that the MDCG is not even […]

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 […]

What is this recommendation about? Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a […]

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 […]

Bill Oakley, a writer on "The Simpsons," admitted on Twitter that perhaps the animated TV show did forecast some of our troubling current events.

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.

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.

California DMV will reopen 25 field offices after shutdown

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

Film critic Justin Chang hosted a live discussion of 'The Avengers,' the first film Times readers chose in the Ultimate Summer Movie Showdown series.

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

The idea that old people are worth something because they contribute significantly to society puts us on a slippery slope.

Nursing facilities account for a large percentage of COVID-19 deaths. Better protection and testing can change that.

It was impossible to maintain any kind of social distance and there was no way to protect oneself from COVID-19.

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

As nations across the globe try to fight a pandemic, many also stop to mark the close of another conflict: the end of World War II in Europe.

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.

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.

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

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.

The drug helped some coronavirus patients recover faster. But it's hardly everything we'd wished for.

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."

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.

LAX and many airlines are now requiring face coverings to avoid coronavirus spread. TSA agents will don them too.

The Ramirezes never thought the coronavirus would get them. They took every precaution, but the virus still found its way into their home. Over the course of days, each member of the 10-person household became infected. Three were hospitalized. And one, the family patriarch, died.

If you factor in a potential undercount of furloughed workers, nearly 1 in 5 working Americans may be in line for unemployment benefits.

Many countries saw the coronavirus as a "rich man's disease" imported by overseas travelers. It has since hit marginalized groups the hardest.

The NFL is operating under the assumption that the season will be played as scheduled, but COVID-19 has created many challenges for the league.

City and county trails reopen this weekend. Almost every day, the rules change in the beaches and parks of Southern California. Here's the latest.

The NFL is operating under the assumption that the season will be played as scheduled, but COVID-19 has created many challenges for the league.

The America that condones mass murder of children is allowing the coronavirus to spread.

A looming recession due to the coronavirus imperils Champagne, buffalo mozzarella and other European delicacies. They're luxuries, but also livelihoods.

Orange County continues to confirm more coronavirus cases. Here's the latest community breakdown.

From cash and snacks to a verbal 'thank you,' there are options when it comes to showing your appreciation for delivery drivers.

COVID-19 victims in their 20s and 30s make headlines, but does it mean the coronavirus has become more dangerous to younger people? Here's what we know.

Merchants rejoice they finally reopen businesses and greet customers, with social distancing

California reopening: On Abbot Kinney Boulevard in Venice, the normally bustling shopping district that has been largely vacant amid the coronavirus, there were signs of life Friday as some retailers opened for curbside service.

Enough is enough, says a growing number of creatives from the fashion industry, including designer Kimora Lee Simmons, stylist Jeanne Yang and designer Prabal Gurung.

Gov. Gavin Newsom's administration sent letters to Modoc, Sutter and Yuba counties warning that the areas could be ineligible for disaster funding unless they adhere to the state's coronavirus reopening plan.

U.S. leadership, or the lack thereof, in the time of coronavirus

Adam Silver told NBA players that a return to the court is up in the air but that games could be held in Las Vegas or Orlando, likely without fans.

If nursing homes will remain closed until a COVID-19 vaccine is available, there will be no family visits for more than a year. That's intolerable.

Older people who are more at risk of dying from COVID-19 contribute immeasurably to society, but they should not have to prove their worth.

The coronavirus-idled events team from a ski resort runs a food bank in Basalt, Colo., pivoting from delivering entertainment to helping the hungry.