- TLDR Biotech
- Posts
- Biotech & Pharma Updates | June 9 - 10, 2024
Biotech & Pharma Updates | June 9 - 10, 2024
Eli Lilly gets full support from FDA advisory panel, GSK's RSV vaccine gets a label expansion, Moderna’s flu/covid combo passes Ph3, Amber Therapeutics raises $100M, Alumis plans an IPO, and the FDA gets curious about AI
Eli Lilly’s Alzheimer’s med gets 11 big thumbs up from FDA advisory panel | gif: Disney Plus
TLDR Biotech aims to be your one-stop source for biotech and pharma updates - all with one daily email.
I’m always looking to make these news compilations more informative, impactful, and easy to navigate.
So if you have any feedback on what you like (or don’t), I’d love to hear from you! 📣
And if you like these newsletters and think a friend or colleague would benefit, please share this with them! ♻️
(You can also reach out to me on LinkedIn)
MINOR HOUSEKEEPING
How these updates are formatted
The newsletter is split into three main sections:
THE GOOD - good news (eg. fundraises, product approvals)
THE BAD - negative news (eg. clinical trial failures, layoffs)
THE UGLY - negative but atypical news (lawsuits, product recalls, scandals)
Within each of the three above parts, there are additional sections for easier navigation:
Eg. There will be multiple “The Good” sections covering things like Fundraises, Approvals, Partnerships etc.
There will be also additional tags within these sections (Eg. fundraises may mention Stage, product approvals may mention drug name and disease area.)
See something you want to get into further? Click the Read More (goes out to either a news article or a press release).
One last thing; I know paywalls can be annoying, so there’s a [Paywall] tag for any news stories behind one.
ENJOYING THESE NEWSLETTERS?
Consider an optional paid subscription.
TLDR Biotech is currently a one-person show that works full-time to put together these compilations and related content.
If you’re getting value out of these daily compilations, please consider a paid subscription (only $5/month) to support my continued work on this project.
⬇️ The Good News ⬇️
THE GOOD
Approvals & Labels
Eli Lilly’s Alzheimer’s med gets full backing from FDA advisory panel
Monoclonal antibody, Alzheimer’s - Read more
GSK get’s expanded approval for RSV vaccine
Recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted vaccine - Read more
Eisai’s subcutaneous Alzheimer’s application accepted by FDA, Jan 2025 decision date
Monoclonal antibody, Alzheimer’s - Read more
Abbott wins again, lands FDA approval for two OTC glucose monitors
Medical device, glucose monitoring, diabetes - Read more
Roche lands EU approval for ALK-positive non-small-cell lung cancer med
Small molecule, lung cancer - Read more
THE GOOD
Business Development
Hear that? Shionogi signs licensing deal with Cilcare
€15M ($16.1M) upfront, €400 ($430M) biobucks + royalties
Small molecule(?), hearing loss - Read more
THE GOOD
Clinical Trials
Moderna touts stellar Ph3 results from flu/Covid combo shot
Flu vaccine, Covid-19 vaccine - Read more
Eli Lilly sMASHes through with positive Ph2 data using best-selling Zepbound’s active ingredient
GLP-1, peptide, metabolic dysfunction-associated steatohepatitis - Read more
Oculis announces positive Ph2 data, plans for Ph3
Antibody fragment, dry eye disease - Read more [Paywall]
THE GOOD
Fundraises
Amber Therapeutics £80M ($100M) Series A
Medical device, neuromodulation, mixed urinary incontinence - Read more
Alvotech refinancing up to $965M
Biosimilars, manufacturing - Read more
SCI Ventures inaugural fund, $27M
Spinal cord injury, paralysis - Read more
THE GOOD
Investments
Kyowa Kirin slaps down $530M for North Carolina manufacturing site
Biologics, manufacturing - Read more
THE GOOD
IPOs
Alumis joins the IPO party after raising more than $600M in private funding
Small molecule, autoimmune, neurodegenerative - Read more
SPONSORED
The journey to success starts with a small batch! 🚀
Unlock the potential of your small batches with White Raven! ✨
At White Raven, we accelerate the production of small batches. 🧪
Our solutions target your unique needs and will help you streamline production, cut time-to-market, and reach your project goals smoothly.
Do not let your small batches go unnoticed! Transform them into success stories!
THE GOOD
Market Reports
A brighter latter-half to 2024 for biopharma? Maybe so with falling inflation and increased funding - Read more
THE GOOD
Partnerships
Dana-Farber Cancer Institute and OncoHost sign research pact
Biomarkers, proteomic plasma profiling, kidney cancer - Read more
THE GOOD
Regulatory
EMA launches two clinical trial advice pilots
Clinical trials, European Medicines Agency - Read more
FDA’s CDER launches the Emerging Drug Safety Technology Program (EDSTP)
AI, pharmacovigilence, emerging technologies - Read more
THE GOOD
Research
University College London and Great Ormond Street Hospital developed hereditary paediatric heart condition blood test
Blood test, hypertrophic cardiomyopathy - Read more
NIH is locked in on H5N1 (avian flu virus) research
Avian flu, bird flu - Read more
THE GOOD
Strategic Plans
Boehringer Ingelheim wants oncology clout, and has a busy few years in store
Small molecule, cancer, oncology, product launches - Read more
⬇️ The Bad News ⬇️
THE BAD
Clinical Trials
Skye Bioscience’s Ph2 failure ends eye disease ambitions
Small molecule, glaucoma, ocular hypertension - Read more
THE BAD
Partnerships
GSK severs collab and licensing agreement with SpringWorks Therapeutics
Small molecule, multiple myeloma, cancer - Read more
THE BAD
Research
Paxlovid doesn’t work for long Covid; study
Small molecule, antiviral, long Covid - Read more
⬇️ The Ugly News ⬇️
THE UGLY
Politics & Policy
Amidst Federal Trade Commission (FTC) war on Orange Book patents, GSK stands its ground
Drug patents, patent law - Read more [Paywall]
You’re all caught up on the latest Pharma & Biotech News!
gif: Offline Granny
TLDR Biotech wants to hear from you! 📣
Have comments/questions/complaints about this newsletter?
Send me an email - I want your brutally honest feedback. 📝
Want to sponsor this newsletter and reach an audience of 300+ biotech and pharma professionals? Reach us here. 👍
Disclaimer: Content, news, research, tools, and mention of stock or tradeable securities are for educational and illustrative purposes only and do not imply a recommendation or solicitation to buy or sell a particular security or to engage in any particular investment strategy. Read the full terms & conditions here.