• 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

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!

90S Vhs GIF by Offline Granny!

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.