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After Alexion buyout, ex-Achillion nephrology lead jumps ship to Gemini Therapeutics

Just a few months after Alexion snapped up complement inhibitor biotech Achillion, Gemini Therapeutics has nabbed one of its key R&D execs as its new chief medical officer.




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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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BENEO president: ‘We have seen higher and more volatile demand during the pandemic’

From fewer containers and reduced shift work at harbors to delays in planned maintenance in factories, the coronavirus pandemic is impacting global supply chains in myriad ways. FoodNavigator-USA (FNU) caught up with Jon Peters (JP), president at Beneo, a leading supplier of chicory root fiber, rice ingredients, and the specialty low-GI carbs Isomalt and Palatinose, to find out more.




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Probiotic combination boosts amino acid absorption from plant protein: RCT

A novel combination of two Lactobacillus paracasei strains may increase absorption of key amino acids in plant proteins, according to a new placebo-controlled, randomized, double-blind, multicenter, crossover study.




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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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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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Experts lay out post-pandemic retailing strategies

Marketing experts recommend that brands formulate a strategy to be as nimble as possible to deal with the as yet unknown changes to the supplement marketplace in the post pandemic world. A greater online capability is seen as one of key parts of that toolkit.




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Case Study: When does “technology” turn into medical device

This semester I’ve embarked on an adventure to co-teach a class in the University of Wisconsin-Madison Masters in Biotechnology program. What sold me on the experience was the majority of my responsibility is interacting with second year students on their final major project (essentially their thesis). That said, I will give one lecture, which will be “health

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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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V-E Day: Europe Celebrates A Subdued 75th Anniversary During COVID-19 Pandemic

"Today, 75 years later, we are forced to commemorate alone, but we are not alone!" Germany's President Frank-Walter Steinmeier says, celebrating international unity in the post-war era.




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Seen 'Plandemic'? We Take A Close Look At The Viral Conspiracy Video's Claims

The video has been viewed millions of times on YouTube via links that are replaced as quickly as the video-sharing service can remove them for violating its policy against "COVID-19 misinformation."




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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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Public Health Experts Say Many States Are Opening Too Soon To Do So Safely

By Monday at least 31 states will be open or partially open. This as President Trump pushed for the country to get back to work despite public health experts warning that it's too soon.




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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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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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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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New EU Rules for Medical Devices

After four years of negotiations, European lawmakers agreed on June 15 on a new EU Medical Devices Regulation (MDR). The MDR is the equivalent to the FDA’s CDRH regulations in the United States and essentially specifies the applicable rules when importing medical devices into Europe, which is the world’s second-largest device market. Rules relate, for...… Continue Reading




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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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Pandemic side effects




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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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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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First coronavirus, now 'murder hornets'? 'The Simpsons' predicts the future again

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




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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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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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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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As coronavirus reshapes campaigns, Republicans fear loss of Senate control

Republicans, once confident of keeping their Senate majority in the fall election, now fear Democrats have a fresh advantage as the coronavirus crisis has reshaped campaigns.




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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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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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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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How coronavirus — a 'rich man's disease' — infected the poor

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




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L.A. traffic is starting to pick up again, and travel speeds are slowing down

California reopening: Traffic volume is steadily creeping up, and travel times are getting longer.




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Column: America's tolerance for mass murder is the coronavirus' best friend

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




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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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Who to tip and how much for doorstep deliveries during the COVID-19 pandemic

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




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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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Yosemite employees evicted amid coronavirus pandemic

The group of Yosemite Hospitality workers were told this week layoffs require them to leave Yosemite by May 21.




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On Venice's hip Abbot Kinney, there are signs of retail life after devastating coronavirus closures

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.




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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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UCLA softball is on 'really big high' with return of Rachel Garcia and Bubba Nickles

UCLA, the NCAA champion in 2019 and the No. 1 team in 2020 when the COVID-19 pandemic hit, got a boost with the return of Rachel Garcia and Bubba Nickles.




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Riverside County officials vote to rescind all local coronavirus public health orders

After nearly seven hours of debate, Riverside County officials voted unanimously late Friday to rescind all of the county's stay-at-home orders that go beyond the governor's restrictions.




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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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Was the coronavirus made in a Wuhan lab? Here's what the genetic evidence shows

Despite President Trump's statements that the coronavirus was released from a laboratory in Wuhan, scientist say the evidence points to a natural origin.




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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