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 800+ biotech and pharma professionals? Let’s chat. 👍

THE GOOD
Approvals & Labels

Novartis nabs FDA label expansion for Kisqali in breast cancer
Small moleclue, breast cancer - Read more

Senseonics continuous glucose monitoring system green-lit by FDA
Medical device, continuous glucose monitoring, diabetes - Read more

Apple Watch lands FDA ok for sleep apnea detection
Consumer electronic, sleep apnea - Read more

THE GOOD
Business Development

Kincell Bio lands new cell therapy client
Cell therapy, CDMO, regenerative medicine, manufacturing - Read more

AC Immune to receive 2nd milestone payment, CHF24.6M ($29.1M) from Janssen following Alzheimer’s Ph2b trial progress
Liposome-based vaccine, Alzheimer’s disease - Read more

Capricor Therapeutics, Nippon Shinyaku sign binding term sheet for European expansion of deramiocel in DMD; $15M equity investment, upcoming $20M upfront + $715M biobucks upon signing definitive agreement
Cell therapy, Duchenne’s muscular dystropy - Read more 

THE GOOD
Clinical Trials

Merck & Co., Daiichi Sankyo developed ADC bests chemo in Ph3 lung cancer trial
Antibody-drug conjugate, lung cancer - Read more

INmune Bio presents further Ph2 Alzheimer’s analyses for trial involving XPro (XPRo1595)
Engineered protein, Alzheimer’s disease - Read more

Vigil Neuroscience VG-3927 Ph1 partial clinical hold lifted by FDA
Small molecule, neurodegenerative disease - Read more

Amgen, Merck & Co. join academic partnership to increase clinical trial diversity
Clinical trial diversity, clinical trial design - Read more

PRESENTED BY ENMORE BIO
China's Largest Biotech Event: BIOCHINA 2025

BIOCHINA 2025 will take place from March 13-15, 2025, spanning 50,000 square meters and accommodating 30,000 participants across 3,000 biotech and biopharmaceutical companies with significant involvement from decision-makers - an ideal venue for fostering partnerships for business development and supply chain optimization.

Key topics will include cell and gene therapy, antibody drugs, and vaccines, with exhibits featuring pharmaceutical and biotech upstream suppliers, including CROs and CDMOs.

Register now and receive a 20% discount on your partnering registration! Promo code: TLDR

⬇️ The Good News (Cont’d) ⬇️

THE GOOD
Fundraises

Cape Fear BioCapital announces seed fund for early-stage therapeutic ventures
Venture capital, seed funding - Read more

Serán nabs $200M investment from Bain Capital
CDMO, manufacturing, facility build-out - Read more

Nura Bio additional $68M raise, $140M Series A total
Small molecule, neurodegenerative disease - Read more

Nomic Bio $42M oversubscribed Series B
Proteomics, protein profiling, drug discovery - Read more

ONL Therapeutics $65M Series D
Peptide, geographic atrophy (GA) with dry age-related macular degeneration (AMD) - Read more

ImmunOs Therapeutics $11M Series C
Fusion protein, cancer - Read more

THE GOOD
IPOs

Kairos Pharma goes public, hauls modest $6M raise from IPO
Monoclonal antibody, lung cancer, prostrate cancer - Read more

THE GOOD
Lawsuits

Johnson & Johnson’s $260M talc verdict overturned in Oregon court, new trial tbd
Talc, mesothelioma, cancer - Read more

Sandoz owed $137M from United Therapeutics over yearslong generics spat, New Jersey district court
Small molecule, medical device, pulmonary arterial hypertension, generic - Read more

THE GOOD
Market Reports

It’s never Lupus, until it is; for those cases, doctors are “eagerly awaiting new entrants”
Autoimmune disease, systemic lupus erythematosus - Read more

THE GOOD
Marketing

Bio lobby PhRMA wants greater freedom to tackle misinformation, pushes FDA to change guidelines
Digital marketing, misinformation - Read more

THE GOOD
Mergers & Acquisitions

Zydus Lifesciences acquires Sterling Biotech’s API business for $10M
Active pharmaceutical ingredient manufacturing - Read more

THE GOOD
Partnerships

AbbVie, Ripple Therapeutics RTC-620 clinical development pact & licensing agreement
Drug delivery, intracameral implant, open-angle glaucoma (OAG), ocular hypertension (OHT) - Read more

Rakovina Therapeutics, Variational AI drug discovery collab
Small molecule, drug discovery, AI - Read more

Unravel Biosciences, The Jackson Laboratory drug discovery collab
Small molecule, drug discovery, AI - Read more

THE GOOD
Patient Access

Vertex Pharmaceuticals, CRISPR Therapeutics’ Casgevy finally reaching sickle cell patients (previously zero treated patients as of August 1st Q2 earnings call)
Gene therapy, sickle cell disease - Read more

THE GOOD
Regulatory

FDA provides more guidance for decentralized clinical trials
Clinical trial design, decentralized clinical trials - Read more

THE GOOD
Research

Emmet Stephenson’s $150M gift to City of Hope for pancreatic cancer research
Pancreatic cancer research, philanthropy - Read more

GLP-1 use reduced liver cirrhosis in MASLD patients by 14%; retrospective analysis
GLP-1, metabolic dysfunction-associated steatotic liver disease, liver cirrhosis - 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
Clinical Trials

Alkeus Pharmaceuticals’ ALK-001 fails to reduce GA lesion growth in Ph3, though secondary endpoint win and other “clinically meaningful” results to inspire further development
Small molecule, geographic atrophy - Read more

THE BAD
Layoffs

Athira Pharma shifts strategy, lays off 70% of workforce
Small molecule, Alzheimer’s disease, myotrophic lateral sclerosis (ALS) - Read more

THE BAD
Patient Access

Coherus BioSciences’ Udenyca (Amgen Neulasta biosimilar) faces supply shortage due to third-party CMO’s “over-commitments and capacity constraints” at packaging facility
Recombinant protein, infection prevention - Read more

THE BAD
Politics & Policy

With Biosecure advancing, biopharma industry seriously considering supply chain what-ifs
Biosecure act - Read more

THE UGLY
Lawsuits

Express Scripts (Cigna subsidiary) sues FTC in Missouri federal court over “unfair, biased and erroneous” PBM report
Pharmacy benefit manager - Read more

You’re all caught up on the latest Pharma & Biotech News!

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.