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

Quick note: We won’t be publishing September 1st for Labour day - next edition on Tuesday, September 2nd.

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

EC approves BeOne's Tevimbra for neoadjuvant/adjuvant treatment in resectable non-small-cell lung cancer, marking fifth lung indication
Antibody, cancer, monoclonal antibody, non-small cell lung cancer, PD-1 inhibitor, neoadjuvant/adjuvant therapy - Read more

MHRA approves GSK's Blujepa (gepotidacin), first new antibiotic type for urinary tract infections in 30 years
Small molecule, infectious disease, antibiotic, urinary tract infection, drug resistance, E. coli - Read more

FDA approves reduced monitoring requirements for Travere's FILSPARI (sparsentan) in IgA nephropathy
Small molecule, renal disease, dual receptor antagonist, IgA nephropathy, REMS modification, endothelin angiotensin pathway - Read more

THE GOOD
Business Development & Partnerships

Fresenius, Charles River Labs lead 18-partner European consortium for rapid hospital CAR-T production with €8M ($9.3M) EU funding
Research collaboration, cell therapy, manufacturing, oncology, Europe, consortium - Read more

Flagship Pioneering and IQVIA partner to enhance clinical research capabilities for Flagship's biotech companies through AI and analytics technologies
Research collaboration, AI/ML, clinical development, drug discovery, data analytics - Read more

Novo Nordisk partners with Replicate Bioscience on RNA-based obesity/diabetes drug development for up to $550M
Licensing deal, obesity, RNA technology, diabetes, milestone payments - Read more

Celaid Therapeutics and AGC partner to expand iPSC-derived hematopoietic stem cells for advanced cell therapy development
Research collaboration, cell therapy, stem cell technology, manufacturing, co-development, R&D - Read more

CAGE Bio partners with Mayo Clinic to develop ionic liquid-based treatments for cutaneous graft-versus-host disease
Research collaboration, immunological, rare disease, drug discovery, dermatological - Read more

PRESENTED BY YOU?
Get the attention of 2000+ 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

Akiram's AKIR001 CD44v6-targeted radiotherapy reports positive Ph1 safety data in solid tumours
Antibody, cancer, radiopharmaceutical, solid tumors, CD44v6 target, radioligand therapy - Read more

Ascletis' ASC30 once-daily GLP-1 tablet shows promising Ph1b results for obesity with favorable pharmacokinetics
Small molecule, metabolic, GLP-1 agonist, obesity, once-daily oral, pharmacokinetics - Read more

THE GOOD
Fundraises

Plexium raises $60.1M funding to advance protein degrader pipeline for cancer treatment
Protein degrader, oncology, small molecule, clinical-stage, IKZF2 target, synthetic lethality - Read more

Reprieve Cardiovascular raises $61M Series B, advancing intelligent heart failure decongestion therapy
Cardiovascular, heart failure, clinical-stage, platform technology, medical device - Read more

Shenandoah Therapeutics raises $21.5M seed round, rewiring cancer signals into death triggers
Oncology, small molecule, platform technology, cancer, preclinical, drug discovery - Read more [Paywall]

EnsiliTech raises £4.5M ($6.1M) seed funding for room-temperature stable biopharmaceuticals technology
Platform technology, biopharmaceutical stabilization, room-temperature storage, services, logistics optimization - Read more

THE GOOD
Marketing

Lykos Therapeutics rebrands as Resilient Pharmaceuticals after $50M funding boost and leadership changes following FDA setback
Psychedelic, MDMA, clinical-stage, neurological, therapeutic - Read more

THE GOOD
Product Launches

Teva Pharmaceuticals launches first generic GLP-1 for obesity, copying Novo Nordisk's Saxenda
GLP-1 agonist, obesity, generic drug, competitive, market access - Read more

THE GOOD
Regulatory

FDA considers noninvasive liver endpoint for MASH trials, boosting biotech shares as Echosens leads effort
Metabolic dysfunction-associated steatohepatitis (MASH), regulatory, diagnostic technology, clinical trials methodology - Read more

THE GOOD
Strategic Plans

Stada eyes fall IPO after CapVest talks collapse
IPO planning, generics, biosimilars, equity investment, commercialization - Read more

THE BAD
Approvals & Labels

FDA rejects Outlook Therapeutics' Lytenava (bevacizumab), anti-VEGF therapy for wet age-related macular degeneration, after Ph3 miss
Protein therapy, ophthalmological, monoclonal antibody, wet age-related macular degeneration, VEGF inhibitor - Read more

FDA issues complete response letter to Telix's Zircaix (TLX250-CDx) for clear cell renal cell carcinoma diagnosis
Radiopharmaceutical, cancer, diagnostic imaging, renal cell carcinoma, PET imaging, manufacturing issues - Read more

THE BAD
Clinical Trials

Prothena halts Ph1 Alzheimer's trial as PRX012 anti-amyloid antibody shows higher brain swelling rates than competitors
Antibody, neurological, monoclonal antibody, Alzheimer disease, ARIA, amyloid beta - Read more

THE BAD
Regulatory

Vertex challenges Maze Therapeutics over MZE829 claims; case referred to federal regulators after Maze declines review
Small molecule, kidney disease, regulatory, competitive - Read more

CDC panel to discuss COVID and hepatitis B vaccines in September following Kennedy's controversial ACIP overhaul
Vaccine, infectious disease, regulatory, operational, public health - Read more

THE UGLY
Politics & Policy

Trump names Jim O'Neill, Silicon Valley investor and Kennedy's deputy, as acting CDC director amid leadership exodus
Public health, infectious disease, regulatory, strategic, political - 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. 📝

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