Epoch 13: The Approval Equation - Unpacking This Year's Drug Approval Trends
First in Class vs Best in Class, Pharma vs Biotech, Accelerated Regulatory Paths
Welcome to the 79 NEW Biotech Innovators who have joined us this month! If you haven’t subscribed, join the 1,759 researchers, investors, operators, academics, clinicians and entrepreneurs by subscribing here:
Hello Avatar! Welcome back for another week of biotech analysis. Today is Sunday, which means this is our Building Biotech newsletter that is focused on discussing biopharma strategy topics. Today we are going to cover trends from new drug approvals. This will begin with drug approval volume (Global/China) which as you can imagine is trending up! We will then dig deeper into the split of these new drug approvals amongst first-in-class and best-in-class therapeutics. From there we will examine the distribution of the 2023 approvals which come from biotech vs pharma. And finally we will explore the impact of accelerated regulatory review on new drug approvals. Today will be a bit dry in a sense that we will be plowing through a lot of raw data. However, for those of us in the business of capital allocation it is critical to understand which profiles are attracting capital and for what reasons.
We are now publishing 4-5x per week according to the following cadence:
Mondays: BioBucks: Stock Analysis & Biotech Catalysts
Wednesdays: CRISPR Corner: Monthly gene editing news (monthly)
Thursdays: Insiders Track: Public & Private Biotech Markets
Fridays: Sweat Equity: Your Weekly Biotech Fix
Sundays: Building Biotech: Strategic Topics
Monday’s BioBucks column will feature Ocular Therapeutics which is slated to share top line data from the PAXTRAVA Phase 2 trial in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT) at the 2024 American Society of Cataract and Refractive Surgery (ASCRS) conference. Options pricing suggest 30% volatility!
Please help spread the work by subscribing and hitting the share button if you are enjoying content!
Lots to cover this week, let's get started!
NEW DRUG APPROVALS
Welcome, today we are going to dive into an analysis on New Drug Approval trends.Looking at the number of new approvals per year is always interesting as a direct measure of innovation, but there is so much more beyond the top level number to direct about new drug approval trends. YoY shifts in the number of new approvals is also a window into each government's underlying philosophy toward innovation and risk management.
We will also cover the always interesting topic of first-in-class vs best-in-class science from the perspective of new approvals. This is a never ending debate so it is always interesting to get the latest data on which class of drugs are actually moving forward.
The topic of biotech vs pharma - who is more productive is also always a fund one. We will have a few cuts of data showing the increasing number of biotech approvals and offer commentary on what we think this indicates.
Finally we will wrap up with the latest data on new drug approvals levergating accelerated regulatory filings. This is also always an interesting topic - which governments are making it easier or harder to get novel therapeutics to patients. Drug discovery is highly capital intensive and geographies which enable cost savings via time savings will always attract interest for developers.
Today’s analysis will be broken down into the following categories:
Drug approval volume (Global/China)
First-in-class vs Best-in-Class
Biotech vs pharma
Impact of accelerated regulatory review
Keep reading with a 7-day free trial
Subscribe to BowTiedBiotech to keep reading this post and get 7 days of free access to the full post archives.