All the top Biotech & Pharma news in one daily newsletter.

Want 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. 📣

THE GOOD
Approvals & Labels

FDA approves Crinetics' palsonify, first oral somatostatin receptor agonist for adult acromegaly treatment
Small molecule, endocrine disorder, oral therapy, acromegaly, somatostatin receptor agonist, rare disease - Read more

FDA approves Eli Lilly's Inluriyo (Oral SERD) for ESR1-mutated advanced breast cancer following Ph3 trial success
Small molecule, cancer, selective estrogen receptor degrader (SERD), breast cancer, estrogen receptor-positive, ESR1 mutation - Read more

Relonchem receives MHRA approval for Moxonidine tablets targeting hypertension treatment in UK
Small molecule, cardiovascular, hypertension, MHRA approval, UK market - Read more

EC approves Eli Lilly's Kisunla (donanemab) for early symptomatic Alzheimer's disease, targeting amyloid pathology in Ph3 success
Monoclonal antibody, neurological, Alzheimer disease, amyloid plaque target, early symptomatic stage, ApoE4 genetic profile - Read more

THE GOOD
Business Development & Partnerships

Merck & Co. licenses Evaxion's AI-based vaccine candidate EVX-B3 for $7.5M upfront, up to $592M total
Licensing deal, vaccine, infectious disease, AI/ML, milestone payments, preclinical - Read more

Lonza's Synaffix, Qurient Therapeutics partner to develop dual-payload ADC targeting solid tumors
Licensing deal, oncology, antibody-drug conjugates, dual-payload technology, co-development, manufacturing agreement - Read more

Gossamer Bio, Respira Therapeutics: Option agreement for on-demand pulmonary hypertension treatment; 2.5M shares upfront, 1.5M upon exercise
Acquisition option, pulmonary hypertension, small molecule, milestone payments, equity investment - Read more

Basilea, BARDA partner on novel oral antibiotic development with $6M initial funding, potential $153M in milestones
Drug development, infectious disease, licensing deal, milestone payments - Read more

PRESENTED BY YOU?
Get the attention of 2200+ Biotech & Pharma Professionals 🤩

Do you offer a biotech/pharma-focused product or service?

Or looking to get investor/analyst interest on your budding start-up?

Considering sponsoring TLDR Biotech to get in-front of an engaged audience of biotech & pharma-focused professionals.

Just reply to this email* or message me on LinkedIn to learn more.

*If you’re reading this on the web version, email [email protected]

✅ More Good News ✅

THE GOOD
Clinical Trials

Immuneering's atebimetinib nearly doubles survival rates in Ph2 pancreatic cancer trial targeting MEK pathway
Small molecule, cancer, MEK inhibitor, pancreatic cancer, combination therapy, first-line therapy - Read more

PepGen reports record 53.7% splicing correction with PGN-EDODM1 in Ph1 myotonic dystrophy type 1 trial
Oligonucleotide therapy, neurological, neuromuscular disease, myotonic dystrophy type 1, splicing correction, genetic disorder - Read more

THE GOOD
Fundraises

FYR raises $8M funding to advance EV-based biomarkers for oncology and neuroscience
Oncology, neuroscience, extracellular vesicles, biomarker discovery, AI-driven, platform technology - Read more

SciTech Development raises $5.5M funding, advancing nanoFenretinide cancer drug in clinical trials
Oncology, nanotechnology, drug delivery, clinical-stage, lymphoma, platform technology - Read more

KalVista Pharmaceuticals raises $110M convertible note offering for EKTERLY commercialization and general operations
Rare disease, pharmaceutical, clinical-stage, drug development - Read more

THE GOOD
Mergers & Acquisitions

Aquavit Pharmaceuticals acquires Axon Technologies, boosting AI and life-science capabilities in strategic expansion
AI technology, strategic, major transaction, operational - Read more

THE GOOD
Politics & Policy

UK signals drug price increases to win back pharma investments from Merck & Co., Eli Lilly after deadlock
Drug pricing policy, strategic, financial, regulatory, international trade - Read more

THE GOOD
Regulatory

NIH invests $87M in organoid center to accelerate drug testing without animals
Organoid model, preclinical development, regulatory, strategic, technological innovation - Read more

FDA releases three draft guidance documents to streamline cell and gene therapy development
Gene therapy, cell therapy, regulatory, strategic, efficiency - Read more

Capricor's DMD cell therapy gets FDA clarity on approval path after July rejection
Cell therapy, rare disease, regulatory, strategic - Read more

THE BAD
Clinical Trials

Eli Lilly withdraws Ph2b trial of bimagrumab, a $1.9B acquisition targeting obesity and Type 2 diabetes
Protein therapy, metabolic, obesity drug, type 2 diabetes, muscle preservation - Read more

THE BAD
Lawsuits

AstraZeneca petitions Supreme Court to challenge Medicare price negotiations affecting $7.7B Farxiga drug
Small molecule, metabolic disease, regulatory, policy, legal - Read more

THE BAD
Layoffs

Heidelberg Pharma cuts 75% of staff after FDA rejection delays $70 million milestone payment
Antibody-drug conjugate, oncology, layoffs, operational, financial crisis - Read more

THE BAD
Regulatory

FDA reviews mifepristone safety protocols after 22 Republican attorneys general request stricter regulations
Abortion medication, women's health, regulatory, political controversy, policy review - Read more

THE BAD
Strategic Plans

Biogen terminates AAV gene therapy program, joining Pfizer and others abandoning viral delivery tech
AAV gene therapy, strategic, operational, cost reduction - Read more [Paywall]

THE UGLY
No Ugly News Today!

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. 📝

If you find the content useful and think a colleague would too, please share TLDR Biotech with them! ♻️

And lastly - connect with me on LinkedIn!

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