For the final time, we would like to thank our sponsor,
Cenetron. A large part of their business is custom specimen kits and as of last month, they had actually produced 11% of all COVID test kits in the US. In fact, when there was a shortage of test kit tubes,
preformed plastic Coke bottles were put into service and Cenetron used those to create sample gathering kits.
Clinical trials demand a logistics provider get it right the first time, on time, every time. With more than 20 years of experience and hundreds of completed clinical trials worldwide, Cenetron is your end-to-end clinical trial management partner.
BioPharmGuy
Feedback
Our subscribers sometimes email us, usually with positive vibes. Here are a few comments we received last week:
"Wanted to thank you for this wonderful newsletter of yours. It brings me so much joy reading it it's hard to put in words. This gets me childishly giggling every time it lands in my inbox. Thanks for that!"
--- Wow, how nice!
"Congrats on this newsletter! I am converted, a big fan- I had a blast reading it. Refreshing, informative and funny"
--- Very cool!
"take me off the list- you should break into Gucci stores to show your disapproval with society."
--- Awesome, thanks!
Addition & Attrition
We added 26 companies this week, and removed two. Summary file available on our
downloads page
.
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Sommetrics
They
requested
FDA emergency use approval of their product due to the pandemic. It's a sleep apnea device. Rationale being that if a person has COVID, a traditional CPAP mask will create more infectious aerosols as compared to their new, unproven technology.
Riiiiiiiight. A bit of a stretch - if you're living with/treating a person who's using a CPAP device and they have COVID, you'd better already be taking some serious precautions when entering that room. Not sure the type of sleep apnea device changes the calculus.
You could really make this kind of tangential-COVID argument for every new-fangled devices. Doubt this request gets approved.
Tetraphase Pharmaceuticals
This is a company that produces anti-infectives. Back in March they agreed to a definitive merger
agreement
with AcelRx. However, a superior offer came through from Melinta Therapeutics and they then signed a definitive merger
agreement
with Melinta on June 4.
In came La Jolla Therapeutics with a 'superiorer' offer and, you guessed it, a third 'definitive' merger
agreement
was signed last week. Maybe it's not over yet....with a name like Tetraphase, it seems like the fourth time should be the charm.
Abbott
They released their rapid diagnostic for COVID back in April to much fanfare. [This is the 13-minute test, not the more common and better diagnostics that are often sent off to a lab]. There are now
many reports
of false negatives coming through. The FDA is suggesting that as long as this rapid test catches 80% of COVID cases, it's ok.
That's
highly
alarming. It means that for every 100 COVID carriers who come to a clinic and get this test, 20 are sent home with a false negative result (and false peace of mind). In comparison, Abbott's competitor Cepheid is showing a 99% catch rate. There is always a balance between false positives & negatives, but the question is, for COVID, would you rather get a false positive and quarantine/stress yourself for no reason, or a false negative and infect dozens of family members, friends and strangers?
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Update on First CRISPR Patient
One year on, the first patient treated with CRISPR gene editing is living well. NPR did a little
feature
. She suffered from sickle cell disease as do many people of sub-Saharan decent. (Sickle-shaped red-blood cells protect against malaria, which has been an African scourge forever. Unfortunately, while they do help you survive into adulthood in malarial environments, they do just about everything else wrong.)
"Since my treatment I've been able to do everything for myself, everything for my kids. And so it's been joy not only for me but for the people around me...in my life"
Great news for biotech!
Premature Inoculation
China's FDA has approved CanSino Biologics' COVID vaccine for military use after showing safety in a phase 1/2 trial. CanSino's connection to the Chinese Army is through a scientist known as Chen Wei. She previously did some vaccine work on Ebola and SARS and in the
latter case
, "she presented her findings on the SARS therapy to Beijing’s municipal authorities after dosing her four-year-old son with it for two months because she was so sure about her research".
As we all know, the mark of a great scientist is their willingness to back up wild overconfidence by risking the life of their own pre-schooler. (Kid was ok...we think. It's China, so can't exactly check a newspaper and expect an honest answer)
Ok back to this vaccine - it's an adenovirus vector vaccine which means it consists of an adenovirus (the vector) plus coronavirus bits bolted on. The adenovirus vector does the job of delivering the coronavirus pieces to where the immune system can react to/recognize them and hopefully spur immunity.
However! Adenovirus is also what causes many common colds and pretty much everyone has had an adenovirus at some point. Maybe because of this, early stage trials showed that about half of people had very little reaction to the coronavirus portion of this vaccine, possibly because the immune reaction focused on the adenovirus itself. If so, it's probably partly a result of a patient's recency of having had a cold - we only retain immunity to particular colds for a few weeks to a few years.
Maybe antibody blood tests could be used to determine if a patient is a candidate for an adenovirus vaccine like this.
DI Why?
Attention-whore DIY Biohacker Josiah Zayner is back
looking for another 15 minutes
of fame. What's a DIY Biohacker? It's a person who injects random, unproven stuff into themselves in the name of 'science'. (At least he's not injecting his children. Yet.)
After his esteemed
Netflix documentary appearance
, he is now planning to inject himself with a homemade coronavirus vaccine. Not sure how he will tell if it worked save for heading to the ICU and volunteering for a few weeks with no PPE. Kinda doubt he will do that, so we will never know if his vaccine works. But he will get eyeballs and that's his real goal.
Ignorance is Strength
The world's largest medical complex, the Texas Medical Center in Houston announced they had hit 100% of standard ICU capacity and were scheduled to exceed their surge capacity on July 6. The next day they decided to
no longer publish
their ICU capacity. Problem solved! Due to public outcry, they seem to have backtracked a bit.
Remdesivir
We have a
price
. For developed country governments, $2340. For private insurers in the US, $3120. This is for a drug that increases recovery time by four days and has shown no statistically significant effect on life expectancy to date. If you have health care in America, you won't see that $3120 price tag, so it isn't all that meaningful. Kind of a made up magical number like all health care costs, really. But if you're one of the 10% of Americans with no health insurance, better sell a kidney or three.
Featured Job
Freudenberg Medical is looking for a Director of Business Development for their Catheter group.
They're looking for someone with 5 years experience in the life science industry with experience in business development, sales, strategic planning, and complex negotiations in business-to-business environments. Job is located in Minnetonka, MN. They would like someone with an MBA, but as you probably know, experience typically is all that matters to most companies. Take a look:
BD Director - Freudenberg Medical
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