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BioPharmGuy
Ok. We're back for the summer. Don't want to use the term "mailed it in" but the past couple weeks we've dipped into our reserve of non-timely newsletter material. Been sitting on that technicolor squirrel for some time and a lot of you seemed to like it, so guess that worked out. We will be catching up on the actual newsy stuff shortly.
June Funding Summary
A bit late but here we go. We tracked $4.5B in private funding rounds at 71 companies around the world for June. Also tracked $3.4B worth of IPOs at 17 companies. Eight of those IPOs were drug companies founded in 2018 or later, none of which have a product in the clinic yet. #notmymoney
Summary file available for download here.
Addition & Attrition
12 companies added, mostly in Europe. One removed. File available on our downloads page.
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Biogen
The FDA has told Biogen to modify the labeling on its Alzheimer's "drug" Aduhelm. The new label will suggest that physicians only use the drug on patients similar to those who took it in the clinical trial. Wow, what a brilliant idea.
How the hell that was not part of the original label? Doesn't matter anyways - FDA doesn't regulate the practice of medicine and a doctor is free to use any drug for any purpose. With a widely publicized drug like Aduhelm, anything the FDA does at this point is window dressing as long as it stays approved.
Meanwhile, insurance companies and the Alzheimer's Association are more or less demanding that Medicare cover the full cost of this drug for almost anyone. So shocking! In the end all U.S. taxpayers will probably be paying billions for this alleged drug that did not show any clinically efficacy in trials. Great.
FDA Inquisition
Acting FDA commissioner Janet Woodcock has requested the Dept of Health & Human Services (of which the FDA is a part) conduct an inquiry into the approval of Aduhelm. Of particular concern are interactions between Biogen executives and FDA officials as far back as 2019. Could be some shady dealings coming to light - stay tuned.
Chimerix
Early in June, the FDA approved Chimerix' flagship product. Normally an approval would be big news, but when your targeted indication hasn't been seen on Earth since 1980 (smallpox), maybe not the biggest celebration. Smallpox isn't even available to do basic research, so this approval was based on infecting animals with viruses that are similar to smallpox. O....K. As long as it's safe, may as well have something ready in case one of the two stores of smallpox virus left in existence break out.
Presidio Medical
Always nice when the outgoing CEO has kind words to say about their replacement, but calling your successor "the Lebron James of neuromodulation" may be a touch over the top. Just whatever you do, do not Google "Lebron James foot".
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Vaccines
As hundreds of millions of Americans have now received a vaccine, extremely rare side effects are being brought to light. Here's what they are and the current best guess to their prevalence:
Johnson & Johnson
mRNA vaccines (Pfizer/Moderna)
In America, the chances of dying once a Covid infection is acquired is something like 1 in 1,000 - never mind the long Covid symptoms we are seeing everywhere. At the rate the delta variant is ripping through the unvaccinated population, the vaccine calculus is pretty clear. (Not that it will matter to most people.)
Fake Vaccine News
Some lazy journal editing led to an outrageously bad anti-vaccine article being published in the journal known as "Vaccines". The three authors of the paper had no training in vaccinology, virology, or epidemiology and their conclusion that vaccines cause deaths was predicated on a citizen reporting system in the Netherlands where anyone can submit any unverified report.
The paper's conclusion implied that all deaths post-vaccination were caused by the vaccine. As we have hammered home many times, people die all the time and some will die after getting these vaccines, just as sometimes people die after watching The Price is Right. As terrible as Drew Carey is, no one is blaming him for those deaths. Yet that's what these bozos did with this paper and somehow that garbage got published.
Spikevax
That's the brand name Moderna will use going forward in Europe and presumably, the US. It's a good, simple name - much better than Pfizer's marble-mouthed Comirnaty. Strangely enough, the same branding consultancy devised both names. If someone's giving you a bunch of money, guess you give them whatever they ask for.
Download Some Covid
Viruses are small. Covid is small enough that the entire genetic code can fit on a standard piece of paper, as a guy on Twitter demonstrated.
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