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

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✅ The Good News ✅

THE GOOD
Approvals & Labels

AstraZeneca, Daiichi Sankyo's Enhertu wins NICE approval for HER2-low breast cancer NHS access
Antibody-drug conjugate, breast cancer, reimbursement, competitive - Read more

Japan's MHLW approves GSK's Shingrix (recombinant zoster vaccine) prefilled syringe for shingles prevention
Vaccine, infectious disease, recombinant vaccine, shingles, varicella-zoster virus, adjuvant system - Read more

Bayer's Kerendia (finerenone) wins third FDA approval for chronic kidney disease associated with type 1 diabetes
Small molecule, metabolic, cardiovascular, mineralocorticoid receptor antagonist, chronic kidney disease, type 1 diabetes - Read more

PRESENTED BY ONYX

Meet the founders, pharma leaders and investors shaping cell & gene therapy.

Cell and Gene Live is a one-day, investor & CEO summit dedicated exclusively to Cell and Gene therapy - the science, the manufacturing, and the investment driving advanced medicines forward. All happening on November 15, 2026.

Speakers confirmed include:

• Steve Bates, OBE (Chair of the UK's Department of Life Sciences)
• Dr. Erik Wiklund (CEO of Circio)
• Edwin Stone (CEO of Cellular Origins)
+ many more!

Get your tickets here - for TLDR Biotech readers, use code ANIS20 at check-out for 20% off.

✅ More Good News ✅

THE GOOD
Business Development & Partnerships

Cellares, GenomeFrontier Therapeutics partner to evaluate Cell Shuttle platform for virus-free CAR-T manufacturing
Research collaboration, cell therapy, manufacturing, oncology, automation - Read more

Novo, Orbis Medicines partner on oral macrocycle cardiometabolic therapies, up to $1.4B in milestones
Co-development, cardiometabolic, small molecule, drug discovery, milestone payments, equity investment - Read more

SK Biopharmaceuticals, 1ST Biotherapeutics ink $314.8M deal for Parkinson's LRRK2 inhibitor 1ST-104
Licensing deal, neurological, small molecule, milestone payments, equity investment - Read more

EpilepsyGTx, Viralgen partner to scale AAV manufacturing for EPY201 ahead of first-in-human trials
Manufacturing agreement, gene therapy, neurological, AAV manufacturing - Read more

Roche, Dualitas Therapeutics partner on bispecific antibody platform for immunology, $36.5M upfront, up to $1B
Licensing deal, bispecific antibody, autoimmune, drug discovery, milestone payments, royalties - Read more

Novo, Anthropic collaborate to accelerate drug discovery and development using AI models
Research collaboration, AI/ML, drug discovery, R&D - Read more

Standigm, Protai launch joint R&D program to design selective molecular glue degraders using AI and structural proteomics
Research collaboration, AI/ML, small molecule, drug discovery, proteomics - Read more

THE GOOD
Clinical Trials

Roche's Lunsumio (mosunetuzumab) meets Ph3 primary endpoint, improving progression-free survival in relapsed or refractory follicular lymphoma
Antibody, cancer, bispecific antibody, follicular lymphoma, CD20xCD3, combination therapy - Read more

THE GOOD
Investments

Reckitt allots $600M to upgrade U.S. operations, expanding manufacturing and R&D capabilities
OTC drugs, consumer health, operational, major transaction - Read more

THE GOOD
Mergers & Acquisitions

North Immunology goes public via reverse merger with Aethlon Medical, raising $180M for eczema drug NOR-101
Bispecific antibody, dermatology, major transaction, financial - Read more

Lisata Therapeutics merges with Marea Therapeutics in reverse merger, raising $225M after failed Kuva Labs acquisition
Small molecule, cardiovascular, strategic, major transaction - Read more

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❌ The Bad News ❌

THE BAD
Clinical Trials

Longeveron's (laromestrocel) stem cell therapy fails Ph2b trial in hypoplastic left heart syndrome
Cell therapy, cardiovascular, stem cell therapy, hypoplastic left heart syndrome, congenital heart disease - Read more

Boehringer Ingelheim terminates Ph3 EASi-KIDNEY trial of vicadrostat (BI 690517) in chronic kidney disease
Small molecule, cardiovascular, aldosterone synthase inhibitor, chronic kidney disease, SGLT2 inhibitor, combination therapy - Read more

THE BAD
Lawsuits

Bristol Myers Squibb, Ono Pharmaceutical face expanded patent infringement claims from Amgen over Opdivo/Opdualag
Antibody, oncology, patent litigation, competitive, royalties - Read more

THE BAD
Regulatory

FDA issues warning letter to Bausch & Lomb over contamination failures, citing lack of remediation commitment
Sterile manufacturing, ophthalmology, operational, regulatory, quality management - Read more

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

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