For my industrial biotech historians: Pfizer made the first recombinant rennin (the key enzyme used in cheese-making) in 1990 and this was the first GMO food sold in the US. Before Pfizer developed that, the bonkers genius described by @JamesMelville had to extract rennin from

$ELDN Trying to decipher if there is a redeemable TPP here despite the lack of stat sig in the Ph2 based on equivalent (or maybe slightly better) efficacy to tacro and improved side effects. TL;DR - Short-term efficacy (composite failure) is slightly worse than SoC tacro,

Today, BillionToOne went public, becoming YC's 4th biotech IPO. As a company that quietly provides societally important infrastructure, BillionToOne is less well known than they deserve to be. Here is their story, from grad students to IPO. BillionToOne is the rare company

Biohaven putting this regulatory timeline graphic in their press release last night was communication done well.

Happy to see $CRVO announce their FDA alignment for their Ph3 in DLB. It largely looks like what they had anticipated, the main change being an extension from a 24wk trial to a 32wk trial. IMO - that is only a good thing to give more time to show slowing of disease progression.

Assuming the drug works, the decision to structure the $QURE AMT-130 trial as a 12mo core trial with a crossover of the placebo group after those first 12mo is in retrospect a super damaging decision. I imagine the reason for this design was that they didn't imagine using this

@SolariumEarth @West0_Cap the bigger issue is a broader one. For as long as I remember, if the FDA gave guidance, that was trustworthy. Companies and investors followed it because the FDA had proven they would follow their own guidance. That is no longer the case

The uncertainty in biotech is supposed to come from clinical data risk -- NOT regulatory whiplash at the FDA. This will scare away much of the generalist capital that was finally looking at biotech again ( $QURE top holders include non-biotech specialists like Jefferies,

Is there any precedent for the FDA reversing BLA regulatory guidance/commitments that they agreed to literally just four months ago? This FDA reversal feels like the type of thing that would make it impossible to plan or invest in biopharma. Uniqure $QURE FDA Alignment in June

Who are the best freelance PR gurus for something new + exciting in the advanced materials space? 👀

Biopharma historical anecdote of the day: Home Depot founder @realkenlangone has been a shareholder in Eli Lilly $LLY since Lilly bought a small med tech company Ivac that he owned in 1977. He took control of IVAC when it was $1.5M -> Lilly bought it for $57M in equity in 1977

I'm reposting this because it is crazy to think that if Mounjaro keeps growing at its current growth rate, it will have over double the sales of Keytruda (the prior best-selling drug of all time) by this time next year!

If there's one tweet that symbolizes the shift in pharma from specialist prescribed + formulary-gated --> consumer facing + transparent pricing: cc: @tjparker's tweet yesterday

Agreed quality of BioX analysis is at an all-time high (or maybe we just all look smart in this market)

This video got me so pumped. I’m gonna go finish the Introduction to Python Harvard Edx course I began in 2017

Bio is a stock picker’s market!

2 approved + 2 NDAs in just over 10 years Has any company ever performed the hat trick (3 drugs approved) in its first decade? My LLM friends can't name one

A reminder of stacked the deck is against you as a biotech investor: There are ~60 FDA new drug approvals each year. There are 600 publicly traded biotech companies (and many more private). Only about ~10% of companies will get a new drug approved each year. Another way of

It’s insane that if you have an approved branded pharma product you have to strictly adhere to fair and balanced advertising. But if, instead, you steal the IP, make up a dose, and compound the product you can put a full page ad like this in the @nytimes. Make it make sense.