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NutraCast Podcast: Michelle Ricker on biohacking

Youâve likely heard of life hacks, which are tricks or shortcuts that help you be more efficient in life. You may or may not have heard of biohacks. But chances are, youâve already tried some without even knowing it. You might even be biohacking right nowâ




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Bifido probiotic may enhance effects of exercise and boost training results: Study

Combining exercise with a bacterial strain isolated from an Olympic weightlifting gold medalist may synergistically increase endurance compared to training or the probiotic alone, suggests data from a mouse study.




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Supporting Biotech Development in Madison

As part of our follow up to our recent Biotech in Wisconsin Meetup about professional development skills, we are asking folks to fill out this poll.




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What is the optimal biotech burn rate?

Ethan Perlstein, founder of Perlstein Lab, asked a question on Twitter and got some great answers from David Grainger, partner at Index Ventures and Katrine Bosley, CEO of Editas Medicine. (You can read the whole thread by clicking through.) @LifeSciVC @sciencescanner @ksbosley @scientre what's the burn rate distribution of biotech NewCos in for the first year of

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Precision in Oncology: Using the Macro and Micro

Last week, the New York Times had a nice piece “A Faster Way to Try Many Drugs on Many Cancers” on basket clinical trials, which matches patients to a therapy based on the genetics of their tumor as opposed to the site of their primary tumor. This type of trial feeds into the current excitement about precision

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Some Questions On The Future Of The Coronavirus Vaccine, Answered

Scientists work tirelessly to find a coronavirus vaccine. But there are some questions to answer: How soon a viable vaccine would be developed? Would billions of people worldwide be able to to get it?




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What Happened Today: Health Care System Crumbles, Testing Questions

Marc Lipsitch, a professor of epidemiology at the Harvard School of Public Health, answers questions about access to testing for COVID-19, false-negative results and the challenges of mass testing.




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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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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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10 Predictions for healthcare



  • in the news

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The MDCG MDR joint implementation plan

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 […]




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The MDR and the Covid-19 recommendation – a possible template for fixing the MDR and IVDR bottleneck

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 […]




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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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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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Coronavirus torpedoes 50th L.A. Pride parade; online celebration planned

The L.A. Pride parade, which would have marked its 50th year, joins the list of events canceled or postponed because of the coronavirus outbreak.




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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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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: 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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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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Op-Ed: We were left to sicken and die from the coronavirus in immigration detention. Here's how I got out

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




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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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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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Opinion: Remdesivir helps beat COVID-19. But the search for a better drug goes on

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




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Opinion: The unemployment rate may be even worse than it looks

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




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Coronavirus is making expectant parents anxious. This doula wants to help

Carson Meyer, daughter of an NBCUniversal executive and sister of jewelry designer Jennifer Meyer, is reaching parents-to-be virtually in the COVID-19 age.




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Hold the Champagne: Pandemic, recession fears hammer traditional European products

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




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'You talkin' to me?' Watch Andrew Cuomo's spot-on Robert De Niro impression

Robert De Niro told Stephen Colbert he wants to play New York Gov. Andrew Cuomo in a pandemic movie. And Cuomo approves.




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3 more inmates die at Chino prison as coronavirus infections continue to spread

Three more inmates died of coronavirus and the number who are infected has more than doubled at the California state prison in Chino, officials said.




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NHL postpones international games planned for 2020-21 season

The NHL announces it is postponing the Global Series games that were scheduled to be held in the Czech Republic and Finland in the 2020-21 season.




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Merchants rejoice as they finally swing open doors and greet customers — with restrictions, of course

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




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News Analysis: Is the coronavirus crisis reason to worry about how other nations view U.S. leadership?

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




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Commissioner Adam Silver tells NBA players that resuming the season remains fluid

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.




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Roy Horn, dark-haired half of flamboyant illusionists Siegfried & Roy, dies of coronavirus-related complications

Roy Horn, the dark-haired half of Siegfried & Roy, raised the white tigers and other animals in the duo's extravagant shows that were one of the biggest draws on the Las Vegas Strip.




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Senior care homes source of nearly half of all California coronavirus deaths, data show

New data analyzed by the Los Angeles Times show that nearly half of all COVID-19 deaths in the state are associated with elder care facilities.




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Op-Ed: With our ski resort closed, we're working at a food bank and feeling all the emotions

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




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A politically connected firm gets an $800-million mask contract with California. Then it falls apart

California's deal with Bear Mountain Development Co. for coronavirus equipment was one of the state's largest.




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Pharmacy Compounders Practicing Pursuant to Section 503A Can Get in the Mix: Compounding Shortage Drugs for Hospital Patients, with Some Limitations

By Karla L. Palmer



  • COVID19
  • Prescription Drugs and Biologics


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Just a Decade Later, DEA Reopens Comment Period for Electronic Prescriptions for Controlled Substances

By Karla L. Palmer




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Not So Smooth of a “Transition”: FDA Sued Over Deemed BLA Transitions – or Lack Thereof

By Sara W. Koblitz




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First child death from mysterious COVID-19-related illness is reported in the U.S

Nearly 100 children in the U.S. have been diagnosed with the newly identified syndrome associated with COVID-19.




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Birx to help lead remdesivir distribution effort as hospitals struggle to access drug

Since the drug was granted emergency use authorization, doctors have been left with no clear path to get it.




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Supply chain headache? Hundreds of millions of syringes will be needed to vaccinate U.S.

The world's largest manufacturer says there's not enough capacity to quickly ramp up production to those levels.




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Meet the Ohio health expert who has a fan club — and Republicans trying to stop her

Some Buckeyes are not comfortable being told by a "woman in power" to quarantine, one expert said.




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The pandemic shows WHO lacks authority to force governments to divulge information, experts say

The WHO has come under criticism for its deferential tone toward China, but the organization denies it withheld information about COVID-19.




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New Zealand's winning virus tactics spell election risks for Ardern