Embedding Your Drug Strategy Within a Solid Foundation for Success
In this whitepaper, we look at the broad set of trends influencing pharmaceutical development and manufacturing strategy today, and how these drivers are influencing new business models with outsourced partners. Download your copy here.
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BioPharmGuy
Unsettling Run-On Email of the Week
"I am a ED patient at this time does this company sells a product called muse if so how would I go about getting some if needed my phone number xxxxxxxxx i am looking for something to cure my problem ASAP please."
...aaaaaand exhale. A quick search of WedMD tells us the product in question, is an intra-urethral suppository NOOOOOPE. Nope. Nope. Nope. Nooooo!
Well then. Now that half of you are squirming in your chairs, it's only fair that we now share this image of a way bigger than necessary trans-vaginal surgery robot.
Happy Thursday, boys and girls!
Addition & Attrition
21 companies added, five removed. Summary on the downloads page.
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Pay for Delay, Go Away
When a drug patent is to expire, a generic drug company challenges that patent. For their trouble, the first generic company to successfully challenge it is awarded six months as the exclusive generic drugmaker for that product. For that time, they could theoretically charge a little less (but not generic-level prices) and make some good loot.
However, for years, the patent-owning company has been free to more or less bribe that generic company to not make or sell any of the drug. It really does seem like it would be illegal, but it's been going on forever.
Now the US 5th circuit court of appeals has ruled in one of these cases that it is an antitrust violation. Wow, it took this long and this high of a court to make the ruling that two companies can't openly conspire to keep a product's price high. Outrageous.
Eli Lilly
They recently requested that the FDA rescind the Emergency Use Authorization for one of their monoclonal antibody Covid treatments, bamlanivimab, as it was not effective against viral variants. The FDA acceded to this request. How big of Lilly to request their own treatment be revoked, right? (Hahahah - maybe you haven't been reading this newsletter long enough.)
Yes, they requested that the FDA de-authorize bamlanivimab as a solo therapy, but the FDA has still authorized it as a dual-therapy with another monoclonal antibody - etesevimab. Guess who owns that one? Go on, guess.
Yes, of course, it's also a Lilly product. The bamlanivimab supply in the US will now be made exclusively available to be delivered alongside etesevimab. Hey hey, what do you know, now they get to sell two antibodies every time!
Don't get us wrong - the data support this, but the headlines/coverage sure make it sound like Lilly is being altruistic. Lilly clarified that they were not requesting Emergency Use Authorization be revoked for bamlanivimab as a monotherapy anywhere else in the world. How interesting.
Masimo
It's cool when The Economist publishes letters to the editor from prominent people. This week, in response to an article they did on the limitations of pulse oximeters for people with darker skin, they received a letter from the co-inventor of the technology who is also the CEO of the medical device company Masimo. Always interesting when someone like that pops in.
Young Again
If we could all just change our name and declare ourselves young again, wouldn't that be great?Abgenomics just changed their name to Altrubio and despite having two prior funding rounds for a total of $27M over the past nine years, they announced $63M in Series A funding. To new life!
CeQur
This company did a Series C funding round in 2015. Last week they jumped directly to a Series C5. What, are they selling luxury cars now?
Jumping from C to C5 reminds us of accomplished reality-skeptic, Ted Nugent, and his astute assertion that no one batted an eye for Covids 1 through 18, but suddenly with Covid-19 we had to shut down the world during an election year!
Speaking of Nugent, after long claiming Covid was overblown, he just announced in a weird Facebook live video (though probably par for his course) on Monday that he has had Covid for ten days now and in his words "I thought I was dying". Imagine that.
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Precautions down? Covid Up.
The thing about 95% effective vaccines is that they're not 100% effective. Plus all the clinical trials run on these things were done in a mask-wearing, large event-banned era. Back then Moderna saw 11 cases out 15000 vaccinated & 185 cases out of 15000 placebo. Hence ~95% effective.
If they were to run that trial now, and it was still 95% effective, the numbers may be more like 55/15000 in the vaccinated group and 925/15000 in the placebo. That would mean we would see a tremendous number of anecdotes from people for whom the vaccine did not work.
People on social media and shock television don't care about aggregate data - they live by anecdotes. As such, the anti-vaxxers and general a-holes are starting to have a field day and it seems like more and more people are succumbing to their anecdotal onslaught.
Pfizer's chief has suggested an annual booster will probably be necessary going forward. Covid is not going anywhere anytime soon thanks to this snowballing anti-vaccine sentiment. Here's hoping the disease gets less and less deadly as it inevitably mutates.
Domestic Vaccine Tourism
With most states open to all ages now, it's become abundantly clear that not all geographic regions need the same number of vaccines per capita. A tremendous number of urban/suburban people are wasting their time driving to rural areas to snag a vaccine. Rural folks in most parts of America simply are not as interested in being vaccinated.
It's probably too late to fix this problem for the initial campaign, but one thing states must avoid is distributing the eventual booster vaccines based on the number of vaccines previously distributed by region. To do so would again force people who already drove hours to get their vaccines to do it all over again.
Seeing that rustic waterfall was nice, but once was enough.
Humonkey Embryo
Scientists in the US, China and Spain have created an embryo consisting of cells from humans and crab-eating macaques. Doesn't get much more horrifying in terms of scientific news. The work was largely conducted in China where laws are more lax.
People argue that there are upsides to doing work like this, such as creating animals with human organs to harvest for transplantation. Even so, to many (most?) people it just seems wrong. Right and wrong do still mean something in society (we think). It will be interesting in the coming decades to watch how various societies choose to address these extreme ethical conundrums.
Mars Air Traffic
Vaccine Anti-Passports?
In a strange twist, a fitness club in Vancouver banned any people who had received a Covid vaccine. You read that right - no vaccinated allowed. The public was not happy and neither was the local government. As it happens, the fitness studio did not have a business license and was violating public health orders. Idiots.
NFT$
George Church, genomics pioneer and all-around life science icon, has decided to hop on the Non-Fungible Token craze and take some money from fools by auctioning off his genome. The auction is set for national DNA day, which is apparently a thing and occurs on April 25.
If you're unfamiliar with NFTs they're like buying the digital deed to a digital house. Seriously.
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