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Teva wins FDA approval for Degevma (denosumab-adet) biosimilar targeting advanced cancer-related bone complications
Protein therapy, cancer, biosimilar, denosumab, bone metastasis - Read more

Eli Lilly's Jaypirca (pirtobrutinib) wins FDA approval for first-line chronic lymphocytic leukemia or small lymphocytic lymphoma
Small molecule, cancer, BTK inhibitor, chronic lymphocytic leukemia, noncovalent BTK inhibitor - Read more

FDA approves Edwards Lifesciences' Autus Size-Adjustable Valve for pediatric congenital pulmonary valve disease
Medical device, cardiovascular, pediatric patients, congenital heart disease, pulmonary valve - Read more

FDA approves expanded manufacturing capacity for Alvotech's Simlandi (adalimumab-ryvk), anti-tumor necrosis factor biosimilar
Biologics, autoimmune, monoclonal antibody, biosimilar, adalimumab - Read more

Novartis acquires option on Abogen Biosciences' mRNA-encoded T cell engager, $575M upfront, $7.8B total
Licensing deal, mRNA, autoimmune, oncology, milestone payments - Read more

CSL, Alentis Therapeutics partner on claudin-1 antibody lixudebart, $355M upfront, up to $1.6B total
Co-development, autoimmune, rare disease, antibody, milestone payments - Read more

Genentech licenses Alector's preclinical blood-brain barrier asset AL050 for $100M upfront, $1.17B milestones
Licensing deal, neurological, enzyme replacement therapy, blood-brain barrier, milestone payments, royalties - Read more

Eli Lilly expands Gate Bioscience small-molecule alliance, adding targets worth up to $870M
Licensing deal, small molecule, drug discovery, milestone payments, royalties - Read more

Teva Pharmaceutical, Samsung Bioepis expand biosimilar partnership to develop and commercialize up to six new candidates
Co-development, biosimilar, autoimmune, commercialization, licensing deal - Read more

Daiichi Sankyo, AstraZeneca, Summit Therapeutics collaborate to evaluate Datroway combined with ivonescimab across multiple tumor types
Clinical trial collaboration, oncology, antibody drug conjugate, bispecific antibody - Read more

Italfarmaco, JCR Pharmaceuticals license JR-141 for Hunter syndrome in US, Europe, and Latin America
Licensing deal, rare disease, enzyme replacement therapy, milestone payments, royalties - Read more

Jiangsu Nhwa Pharmaceutical licenses sleep disorder drug to Somnivera for up to $518M
Licensing deal, neurological, sleep disorders, milestone payments, royalties, equity investment - Read more

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.

(Hosted by Onyx at The Shard in London as part of London Life Sciences Week)

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.

Kailera Therapeutics, Hengrui Pharma's ribupatide (GLP-1/GIP) shows 20.2% weight loss in Ph2 polyendocrine metabolic ovarian syndrome trial
Protein therapy, metabolic, GLP-1/GIP dual receptor agonist, polycystic ovary syndrome, obesity, ribupatide - Read more

Vaxcyte's VAX-31 meets Ph3 endpoints against Pfizer's Prevnar 20 and Merck & Co.'s Capvaxive for pneumococcal disease
Vaccine, infectious disease, pneumococcal conjugate vaccine, streptococcal disease, immunogenicity, adult immunization - Read more

Biogen's (litifilimab) Ph2 durability data show deepening skin clearance responses in cutaneous lupus erythematosus
Antibody, autoimmune, monoclonal antibody, lupus, cutaneous lupus erythematosus, BDCA2 - Read more

Pfizer shares Ph3 results for Litfulo (ritlecitinib) targeting JAK3/TEC in nonsegmental vitiligo ahead of regulatory filings
Small molecule, autoimmune, JAK inhibitor, vitiligo, ritlecitinib - Read more

Genmab's (rinatabart sesutecan) Ph2 data show superior efficacy over AbbVie's Elahere in platinum-resistant ovarian cancer
Antibody-drug conjugate, cancer, ovarian cancer, FRα target, ADC comparison - Read more

Ractigen Therapeutics' RAG-18 (rag-18) shows Ph1 proof-of-mechanism via utrophin upregulation in Duchenne muscular dystrophy
RNA therapy, neuromuscular disease, small activating RNA, Duchenne muscular dystrophy, utrophin upregulation, mutation-independent therapy - Read more

Celaid Therapeutics completes Series B second close, raises $2.6M advancing CLD-001 U.S. development
Clinical-stage, small molecule, therapeutic development - Read more

Biotia raises $9M in funding to expand diagnostics in women's health and orthopedics
Infectious disease, metagenomics, diagnostics, AI/ML platform, women's health - Read more

TriGemX Bio raises $94M in funding to advance Phase 3 migraine treatment elismetrep
Neurological, small molecule, migraine, clinical-stage - Read more

Bayer invests $2.2B in Ohio manufacturing site to expand U.S. pharma presence
Manufacturing, oncology, cardiovascular, strategic, major transaction - Read more

Talus Bio unveils Ptarmigan-1 AI model, predicting drug binding without protein structures for difficult targets
Small molecule, autoimmune, AI drug discovery, competitive - Read more

Xaira Therapeutics unveils X-Design AI antibody platform and first pipeline candidates after $1B launch
Monoclonal antibody, oncology, AI drug discovery, strategic - Read more

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.

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Adecto Pharmaceuticals, Aviceda Therapeutics shut down amid fundraising challenges and failed clinical trial results
Monoclonal antibody, oncology, ophthalmology, operational, cost reduction - Read more

Novo faces FDA hemophilia review extension due to manufacturing site remediation issues, delaying Frehemgo U.S. approval
Bispecific antibody, hemophilia, regulatory, operational, manufacturing - Read more

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