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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

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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:

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Dr. Erik Wiklund (CEO of Circio)
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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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