- TLDR Biotech
- Posts
- Biotech & Pharma Updates | September 26 - 29, 2024
Biotech & Pharma Updates | September 26 - 29, 2024
Regeneron, Sanofi’s Dupixent gets FDA ok for label expansion, Bavarian Nordic lands another mpox vaccine contract, BlueRock, Bayer showcase 24 month safety data for Parkinson’s disease cell therapy, Cassava’s $40M SEC settlement, Travere halts Ph3 due to drug substance issue, J&J gets final warning letter from HRSA to halt 340B rebate program
After 3 month delay, Regeneron & Sanofi’s label expansion for COPD med Dupixent gets FDA stamp of approval. | Gif: johnbcrist on Giphy
All the top Biotech & Pharma news in one daily newsletter.
What to understand how these updates are formatted? Check-out the FAQ.
Have any feedback? I’d love to hear you from - connect with me on LinkedIn. 📣
Looking to reach an audience of 950+ biotech and pharma professionals? Let’s chat. 👍
⬇️ The Good News ⬇️
THE GOOD
Approvals & Labels
Regeneron, Sanofi’s COPD med Dupixent, after delay, get’s FDA approval for expanded label
Monoclonal antibody, chronic obstructive pulmonary disease - Read more
China also approves Regeneron, Sanofi’s Dupixent for COPD
Monoclonal antibody, chronic obstructive pulmonary disease - Read more
THE GOOD
Business Development
Bavarian Nordic lands another mpox vaccine contract, this time with UNICEF for 1 million doses
Vaccine, monkeypox (mpox) - Read more
THE GOOD
Clinical Trials
Johnson & Johnson touts new data from Talevy, Tecvayli combo in multiple myelkoma, though side effects may be cause for concern
Bispecific antibody, multiple myeloma, cancer - Read more
Poseida Therapeutics showcases interim Ph1 data for allogeneic CAR-T P-BCMA-ALLO1 in multiple myeloma
Cell therapy, multiple myeloma, cancer, allogeneic CAR-T - Read more
BlueRock Therapeutics, Bayer present 24 month Ph1 safety profile data for cell therapy Bemdaneprocel in Parkinson’s disease
Cell therapy, Parkinson’s disease, stem-cell derived - Read more
IASO Bio presents Ph2 data for CAR-T Fucaso in multiple myeloma
Cell therapy, multiple myeloma, cancer, CAR-T - Read more
UCB touts two-year Ph3 data for bimekizumab-bkzx in hidradenitis duppurativa
Monoclonal antibody, hidradenitis suppurativa - Read more
THE GOOD
Criminal Acts
Cassava Sciences settles with US SEC, $40M penalty, related to “negligence-based disclosure charges” for simufilam Ph2b trial
Small molecule, Alzheimer’s disease - Read more
PRESENTED BY YOU?
Get 950+ sets of biotech/pharma eyeballs on your product or service 👀
Gif by UPexpress on Giphy
Looking to promote your biotech/pharma/life science-focused product or service to a captivated audience of industry professionals?
Consider sponsoring TLDR Biotech - your sponsored feature would go right here!
Ready to make a deal (or want more info)? Just reply to this email or message me on LinkedIn.
⬇️ The Good News (Cont’d) ⬇️
THE GOOD
Fundraises
Mendaera $73M raise
Medical device, handheld robotics - Read more
C2N $7.025M raise
Diagnostics, blood test, Alzheimer’s disease - Read more
ENJOYING THESE NEWSLETTERS?
Support TLDR Biotech🧬🦠🔬
I’m offering this newsletter for free so it can get out to as many people as possible.
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.*
*Best of all, it’s a work-related news source that you can likely expense. 😉
⬇️ The Bad News ⬇️
THE BAD
Clinical Trials
Travere Therapeutics halts Ph3 pegtibatinase trail enrolment due to drug substance manufacturing scale-up issue
Recombinant protein, classical homocystinuria, manufacturing - Read more
THE BAD
Patient Access
Novo Nordisk pares down some insulin pen manufacturing, transitioning to needle + vial supply
Insulin, diabetes, drug delivery - Read more [Paywall]
THE BAD
Politics & Policy
US Health Resources and Services Administration calls Johnson & Johnson by their full name, issues last warning to halt their proposed 340B rebate model
340b drug pricing, drug rebate program - Read more
⬇️ The Ugly News ⬇️
THE UGLY
Criminal Acts
Former FDA medical device chief called out by two House Democrats, who are urging HHS to investigate potential past conflicts of interest
Medical device, conflict of interest - Read more
You’re all caught up on the latest Pharma & Biotech News!
Today in Canada - September 30th marks National Day for Truth and Reconciliation. | Source
TLDR Biotech wants to hear from you! 📣
Have comments/questions/complaints about this newsletter?
Send me an email - I want your brutally honest feedback. 📝
Last thing - if you find the content useful and think a colleague would too, please share TLDR Biotech with them! ♻️
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