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BioMarin pens gene therapy pact with little-known Swiss biotech

BioMarin Pharmaceutical is boosting its early-stage pipeline by penning a deal with Swiss startup Dinaqor.




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Could Sanofi and Regeneron's Dupixent also treat age-related macular degeneration?

Sanofi and Regeneron’s Dupixent has become a popular treatment for atopic dermatitis and asthma. Now, a research team in Japan has discovered that IL-4 and its receptor—which Dupixent inhibits—could be promising targets for treating the eye disease age-related macular degeneration.




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No difference found in caffeine's effects on exercise power among 'fast' or 'slow' metabolizers

A recent study looking at the effects of caffeine on brief, high intensity exercise found the substance improved performance, regardless of genetic variations in how subjects metabolized caffeine.




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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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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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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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None Better than One? (A Brief Note on VC in Smaller Hubs)

Biotech venture funding metrics continue at historic highs, highlighting that the robust financing environment in the public markets continues to fuel the private markets as well.  – Bruce Booth, partner Atlas Venture in Data Snapshot: Venture-Backed Biotech Financing Riding High, April 2015 Here in Madison, Wisconsin, you might not know that was true if you

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The Terrible, Horrible, No Good, Very Bad Pharma Day*

A challenge You are passionate about providing an intervention (drug or device) to a group of patients who can’t access the current options due to availability or pricing. You could could go the philanthropic route to pay for the interventions. You could work towards regulation to apply downward pressure on pricing. No matter what, you have to

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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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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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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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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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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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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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COVID-19 cases higher among San Diego's Latinos; advocates call for more testing

In several states and in parts of California, black and Latino people are dying of COVID-19 at higher rates than their white and Asian counterparts.




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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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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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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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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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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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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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California begins reopening economy as select businesses unlock doors

Parts of California, including Los Angeles County, are allowing some businesses to offer curbside service Friday.




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California voters asked to vote by mail in November due to coronavirus fears

Gov. Gavin Newsom ordered ballots be mailed to the state's 20.6 million voters for the November election while imposing new rules for in-person voting.




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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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It's not safe to reopen Tesla factory, Alameda County tells Elon Musk

Tesla must follow the same rules that apply to other nonessential businesses, Alameda County officials said.




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Trump's new 2020 message — it's not my fault

With the economy in free fall and deaths still rising from the coronavirus crisis, President Trump argued Friday that voters shouldn't hold him responsible.




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'It's not what this town is about': Seal Beach's Main Street struggles to come back

It is an "eerie" day in Seal Beach as businesses struggle to come back and crowds stay away.




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Did coronavirus spread through a nail salon? Newsom said so, and now owners fear for their business

Did community spread of the coronavirus start at a nail salon? Governor said so, and now immigrant owners worry about getting business.




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Older does not equal expendable. We need to act in a way that protects our elders from coronavirus

Older Americans deserve our protection from coronavirus. They want to get back to their busy lives, too




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HHS Broadly Interprets PREP Act Immunity: Reasonable Belief is Good Enough

By Anne K. Walsh



  • COVID19
  • Prescription Drugs and Biologics

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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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If At First You Don’t Succeed, Bring Another Lawsuit: PMRS Takes a Loss in Court

By Sara W. Koblitz



  • Prescription Drugs and Biologics

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What you need to know about coronavirus home-testing kits

The most important thing to know is that the FDA has not approved any at-home diagnostic tests and only one at-home collection kit for the coronavirus.




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Oregon strip club now delivers food — and a dance on the side

Lucky Devil's dancers put on a show in the parking lot when customers order takeout.




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Not enough evidence that e-cigarettes help to stop smoking, surgeon general says

The surgeon general's report is the first in 30 years to focus entirely on quitting tobacco.




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California governor says community spread started at nail salon

He said he couldn't provide more information because of health and privacy concerns.




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No specialist needed: Fujifilm cuts coronavirus test to 75 minutes




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Asia scans the world for best practices to reopen economies




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Japan's Shionogi primed to mass-produce coronavirus vaccine in 2021




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Tesla insists Shanghai production stoppage 'normal'




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China's road operators left battered by no-toll policy




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Kim Jong Un's sister and the fight for North Korea's bloodline




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No bitterness: Chinese company raises $500m in US despite Luckin