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Pfizer, BioNTech dose first U.S. subject with COVID-19 vaccine

Pfizer and BioNTech have begun dosing participants in a U.S. clinical trial of their COVID-19 vaccine candidates. The dose-escalation stage of the trial will enroll up to 360 subjects, initially out of sites in New York and Maryland.




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CSL Behring joins pandemic R&D fight with antibody work

Australia’s largest biotech company CSL says it is working on a plasma-based therapy for patients with more severe forms of COVID-19.




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COVID-19: Lilly ramps up to beat the virus with neutralizing antibodies as scientists raise worries

Eli Lilly has teamed with China’s Junshi Biosciences in the U.S., marking the company's second COVID-19 pact to develop neutralizing antibodies against the virus. It promises to be a faster approach than designing a new small-molecule drug would be, but getting from idea to an effective product may not be so simple.




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GSK taps experimental arthritis antibody to calm the cytokine storm hitting COVID-19 patients

GlaxoSmithKline is hard at work with partner Sanofi in getting a vaccine tested for COVID-19, but this morning it said it was now also entering the race to treat patients already hit with the disease.




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Sorrento ventures into COVID-19 with Mount Sinai antibody pact

Sorrento Therapeutics is jumping into the race to develop therapies against COVID-19, teaming up with Mount Sinai to develop a cocktail of antibodies from the blood of 15,000 recovered patients. The company's scientists believe their multipronged therapy will sidestep risks such as treatment resistance.




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Fortress joins KRAS race through Columbia University deal

Fortress Biotech has licensed a treatment for KRAS-driven cancers from Columbia University. Sticking to its blueprint, Fortress has set up a new biotech, Oncogenuity, to advance the preclinical asset and work to generate more oligonucleotides from the underlying platform.




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Orchard Therapeutics cuts 25% of staffers, rethinks pipeline, closes California site

Tough times at Orchard Therapeutics as it swings the ax across staffers and facilities, phases in new pipeline advances and reduces interest in others.




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What’s driving sports nutrition segmentation?

A new report out by Innova Market Insights has identified several new trends that are driving sports nutrition.




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Despite sales bump, brands that are not preparing for stormy seas ahead could struggle, consultant says

The dietary supplement industry as a whole is enjoying booming sales as consumer stock up on products to support optimum health. But an industry strategist warns that that sales bump is likely to be ephemeral, and brands that are not strategizing vigorously now may be caught out in the near future.




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‘Overwhelming evidence’ supports Vitamin D’s immune function benefits

There is an âindisputable relation between vitamin D and the immune systemâ, says a new review that shows that avoiding vitamin D deficiency has clear benefits for immune health.




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Report: “Calm” resonates with consumers

Recent research suggests that some brands may want to calm down their messaging.




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Persona CEO Jason Brown on state of personalized nutrition

Consumers arenât just looking for custom-made approaches any more, theyâre expecting it. As technology advances, more companies are offering custom nutritional solutions.




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Personalized Nutrition: New research highlights value society places on genetic testing

The results provide priceless information on ancestry and predispositions to various illnesses.




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Herbal ingredient supplier benefits from incontinence product supply problems

The unpredictable spikes in demand that are distorting the supply chain in the current crisis has created another opportunity, in this case for herbal ingredients that help adults deal with urinary incontinence issues.




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Lief Labs launches GMP starter kit initiative

The GMP Starter Kit aims to help guide brands through current Good Manufacturing Practices (cGMP) regulations and FDA compliance for nutritional and dietary supplement brands.




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Google Says Most Of Its Employees Will Likely Work Remotely Through End of Year

The tech giant announces it is extending its previous work-from-home plans for most of its staff and will begin reopening offices this summer.




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Coronavirus FAQs: Do Temperature Screenings Help? Can Mosquitoes Spread It?

And as summer nears, the question must be asked: Is it risky from a COVID-19 standpoint to go in a swimming pool?




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Haitian Doctor Says This Is The Worst Epidemic He's Faced

A major health agency fears a humanitarian crisis. Migrant workers are returning home from the hard-hit Dominican Republic. Medical equipment is in short supply. And social distancing is improbable.




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COMIC: Hospitals Turn To Alicia Keys, U2 And The Beatles To Sing Patients Home

Call them victory anthems. Every time a patient with COVID-19 is well enough to be discharged, hospitals in New York and elsewhere play songs of celebration over the intercom. A doctor explains.




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Reopening After COVID: The 3 Phases Recommended By The White House

President Trump wants businesses to start reopening after the coronavirus forced shutdowns. Here's what the White House task force recommends for states.




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En Banc: Federal Circuit Provides Guidance on Application of On-Sale Bar to Contract Manufacturers

Pharmaceutical and biotech companies breathed a sigh of relief Monday when the Federal Circuit unanimously ruled in a precedential opinion that the mere sale of manufacturing services to create embodiments of a patented product is not a “commercial sale” of the invention that triggers the on-sale bar of 35 U.S.C. § 102(b) (pre-AIA).[1]  The en banc opinion...… Continue Reading





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Brexit is a fact – now deal with it

Following the European Parliament’s vote, the Council has now also agreed to the Brexit with its decision on the conclusion of the withdrawal agreement on behalf of the EU. The EU Parliamentarians sang off the UK members and celebrated that they never have to speak to Nigel Farage again. UK EU civil servants are clearing […]




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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 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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I'm gaining weight in quarantine and I couldn't be more thrilled about it

If the worst thing that happens to me during this global pandemic is that I have to buy new pants, I will weep with gratitude.




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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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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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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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Axl Rose called Steven Mnuchin an expletive on Twitter, sparking 2020's weirdest feud

Guns N' Roses frontman Axl Rose criticized Steven Mnuchin and Trump's coronavirus response, which irked the Treasury secretary and started a Twitter spat.




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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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Editorial: L.A.'s trails and parks are reopening. C'mon, people, don't screw it up this time

For goodness sake, if you're going to hike, wear a mask.




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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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'A wild ride': Expanding coronavirus testing takes center stage with reopening

Until millions of Americans can be tested weekly for coronavirus, states will walk blindly into restarts. But NIH director has a plan to ramp up.




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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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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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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: Old Americans shouldn't have to prove their value to combat ageism

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




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Column: No, wearing a mask isn't for libs. It's for people who don't want to die

The daft showdown over coronavirus masks wouldn't matter if we didn't live in the political tinderbox that is Trump's America.




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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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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.