May 24, 2022

Newsletter: Texas Two-Step: Back To Square One | May 24th, 2022

Texas Two-Step: Back To Square One


Hey there,

 

Weird and wild. That’s the only way I can describe the last few weeks:

  •  A decision in a landmark court case is imminent— one that has uprooted and divided much of America. Depp v. Heard will likely go into June.

  • The art world is on fire despite heading into a recession.

  • Dr. Oz may soon be a US Senator but still too close to call.

  • President Biden commits to going to war with China if they become more aggressive towards Taiwan.

  • Multiple mass shootings are reported across the US, including two different cities in New York.

  • At 96, Dick Van Dyke signs up for a fitness class. I thought I couldn’t feel worse about my lack thereof.

  • The stock market, particularly the NASDAQ tech index, has made all of us seasick.

  • Albert Pujols, the Cardinal's 42-year-old slugger with 681 HR, closes the last three innings against the San Francisco Giants. I couldn’t find a link of Adam Wainwright calling the game. If it’s out there let me know, but here’s some of the transcript for folks who missed it. If you’re a baseball fan, it’s hilarious.

We may not be able to predict the markets but one thing we can predict is that AI will eventually take over the world.

 

CB Insights released their 100 most promising private AI companies in the world.

 

Here are the ten healthcare companies that made the cut:

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 In other news, biotech stocks are tanking left and right and startups that have raised money recently are wondering if they should alter their plans. One of the most successful accelerators, Y-Combinator had some thoughts for founders.

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 If you don’t know what “Default Alive” means— you better look it up.

 

Agree with #3 as well, but see number #2. Also, maybe this will inject some realism into startups. Seen a lot of companies go through this valuation lesson in the last few years.

 

Speaking of throwing money around…

Big Pharma’s Ad Spending

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Ever wonder which drug category gets the most advertising $$$ in Pharma-land?

 

The folks over at Media Radar compiled some interesting data. Here are the top spots where Big Pharma allocated its advertising budget:

  1. Diabetes (12% of total spending)
  2. Psoriasis (10%)
  3. Arthritis (9%)
  4. HIV/AIDS (6%)
  5. Breast Cancer (6%)
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Last year the top spots accounted for 46% of all spending.

 

News to me. I would have thought would oncology higher and male libido #1.

 

Overall, spending increases have been limited over the last year. Spending in 2021 only went up 1%.

 

Television is still king in regards to where the money was spent, but things will continue to move digital as time goes on. Just gotta make sure you keep your social media game in check and don’t do this or this.

Newly Approved Breathalyzer Diagnoses Covid-19

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As the Covid-19 pandemic surges in various parts of the world, a new medical device could change the way we diagnose the virus.

 

The FDA recently approved the first breathalyzer test used to diagnose Covid-19, InspectIR’s PNY-1000 Mobile Covid-19 Screen Device. It is portable, noninvasive, and displays results in about three minutes.

 

How does it work? A patient uses a straw to blow 10 seconds’ worth of breath into the suitcase-like machine. The device uses gas chromatography gas mass-spectrometry (GC-MS) to detect five Volatile Organic Compounds (VOCs) found in exhaled breath that is associated with the SARS-CoV-2 infection.

 

This mini mass spectrometer is pretty accurate. In a study with over 2,400 patients, the device correctly identified 91.2% of positive samples and 99.3% of negative samples.

 

Even with the accuracy, the FDA urges confirming positive test results with a molecular test.

J&J “Two-Steps” Back To Trial?

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Remember the baby powder controversy that embroiled J&J a little while back?

 

What about the part where J&J employed a controversial practice now dubbed the “Texas Two-Step,” that allows them to spin off a single product onto a separate company? In this ploy, all of the lawsuits follow the newly created subsidiary, and that newly created company files for bankruptcy, minimizing the effect of lawsuits on J&J. 

 

Yeah, that one. Looks like someone put another quarter in the jukebox because this dance is far from over.

 

U.S. Bankruptcy Judge Michael Kaplan, who back in February gave the green light (and a lot of praise) to J&J’s strategy to swerve litigation and the potential massive payouts, passed the case along to the Third U.S. Circuit Court of Appeals. Usually, these cases are appealed to a US District Court, but federal judges have the discretion to certify certain matters straight to the appeals court if they believe the matter is that important.

 

J&J claims its spinoff, LTL Management Company, and Chapter 11 filing will be used for a $2B trust fund to pay out victims. Last year, J&J doled out $2B to about 22 women after losing a jury trial. Unlikely that another $2B will cover the 38,000 claims against them.

 

Let’s see how the federal appeals court handles this. A lot of eyes will be on this case. It’s going to set a precedent for future lawsuits of this kind.

FDA Clears In Vitro Test For Alzheimer’s

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An estimated six million Americans are suffering from dementia caused by Alzheimer’s disease. And in the US Alzheimer’s ranks seventh as the leading cause of death.

 

But a newly FDA-cleared in vitro test could potentially change the way we detect the early onset of Alzheimer’s.

 

Fujirebio Diagnostics developed the Lumipulse test to be used for adults 55 and older. It works by detecting amyloid plaques in cerebrospinal fluid. Although found in other conditions, cerebrospinal fluid can be an indicator of Alzheimer’s.

 

The real benefit to the patient is they can avoid “costly and cumbersome” PET scans with a test that is as accurate as a PET scan.

 

In a clinical study with 300 patients, 97% of positive cases matched with the PET scan— along with 84% matching up with the negative results.

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Hope you all have a good week. Apparently, Memorial Day is this weekend. I had no idea until the nice person cutting my hair yesterday asked what my plans were.

 

I hope you have a better answer than I did.

 

Very truly yours,

 

Kevin

Upcoming Events

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Discover effective strategies for outsourcing clinical trial operations to ensure trials run smoothly and within budget

 

Join us for a two-day event filled with case studies, panel discussion, and face-to-face networking opportunities around clinical operations, technology and innovation, and data management.

 

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AdvanSE by Southeast Life Sciences is the premier life science conference in the southeast United States.

At this year’s event, we will be highlighting the innovations of over 50 early-stage MedTech and bioscience companies. 

 

It is a must-attend event for the biopharma, MedTech, diagnostic, and digital health industries wishing to do business in the Southeast region.

 

Take a look at the event agenda here!

M1 Applications Are Now Open! 

M1  MedTech is thrilled to announce that applications are open for our Fall 2022  cohort! We are seeking early-stage medical device companies that are ready to  bring the next big medical breakthrough to market.

 

🚀 Ready to launch? Head to our website, M1MedTech.com, to  submit your application by our July 1st, 2022 deadline. We can’t wait to get  started!

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