
uniQure submits US marketing application for Huntington's gene therapy AMT-130, seeking accelerated approval | Gif: therokuchannel on Giphy
All the top Biotech & Pharma news in one daily newsletter.
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✅ The Good News ✅
THE GOOD
Approvals & Labels
Samsung Bioepis gains Japan approval for (ustekinumab) biosimilar targeting IL-12/IL-23 in moderate-to-severe active Crohn's disease
Biosimilar, autoimmune, monoclonal antibody, Crohn's disease, IL-12/IL-23 inhibitor - Read more
Everest Medicines' CARDAMYST (etripamil) wins China NMPA approval for paroxysmal supraventricular tachycardia following Ph3 success
Small molecule, cardiovascular, calcium channel blocker, paroxysmal supraventricular tachycardia, nasal spray, self-administration - Read more
THE GOOD
Business Development & Partnerships
Fortrea acquires Worldwide Clinical Trials' early-phase division for $45M to expand CRO platform
Acquisition, CRO services, clinical pharmacology, drug development, bioanalytical laboratory - Read more
Pfizer offloads Seagen ADC PF-08046031 to Medicus Pharma for $12M upfront, $1B+ milestones
Licensing deal, oncology, antibody-drug conjugate, milestone payments, royalties - Read more
GSK, HUTCHMED partner on HMPL-A830 cancer therapy, $110M upfront, up to $1.3B total
Licensing deal, oncology, antibody, small molecule, milestone payments, royalties - Read more
Owkin, Boehringer Ingelheim partner on agentic AI platform K Pro and multimodal cancer dataset licensing
Licensing deal, AI/ML, oncology, drug discovery, multimodal data - Read more
Nxera Pharma receives $8.6M milestone from Centessa Pharmaceuticals on OX2R agonist late-stage development progress
Milestone payments, neurological, small molecule, royalties, research collaboration - 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.
(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.
✅ More Good News ✅
THE GOOD
Clinical Trials
AbbVie's (etentamig) shows positive Ph3 results in relapsed/refractory multiple myeloma, improving response and survival
Antibody, cancer, bispecific T-cell engager, multiple myeloma, BCMA target, relapsed/refractory - Read more
Summit Therapeutics, Akeso's (ivonescimab) beats Merck & Co.'s Keytruda in Ph3 overall survival and progression-free survival in non-small cell lung cancer
Antibody, cancer, bispecific antibody, non-small cell lung cancer, PD-1/VEGF, immunotherapy - Read more
Revolution Medicines' Rasonque (daraxonrasib) Ph1/2 data support RAS inhibitor's potential in non-small cell lung cancer
Small molecule, cancer, RAS inhibitor, non-small cell lung cancer, pancreatic cancer, KRAS mutation - Read more
Raziel Therapeutics, Fosun Pharma's RZL-012 meets all Ph3 endpoints in submental fat reduction, paving way for China NDA
Small molecule, metabolic, focal fat reduction, submental fat, aesthetics, phase 3 - Read more
THE GOOD
Company Launches
Typewriter Therapeutics launches with $56M Series A for RNA-based in vivo CAR-T, gene-insertion platform
Gene therapy, cell therapy, CAR-T, RNA platform, lipid nanoparticles, preclinical - Read more
THE GOOD
Fundraises
NeuShen Therapeutics raises $80M+ Series B to advance CNS pipeline into clinical trials
Neurological, small molecule, depression, clinical-stage - Read more
THE GOOD
Market Reports
Eli Lilly poised for $900M–$1.2B annualized Medicare GLP-1 Bridge sales, analyst estimates
GLP-1, obesity, revenue impact, Medicare - Read more
THE GOOD
Regulatory
uniQure submits US marketing application for Huntington's gene therapy AMT-130, seeking accelerated approval
Gene therapy, neurological, regulatory, rare disease - Read more
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❌ The Bad News ❌
THE BAD
Clinical Trials
Ultragenyx's GTX-102 (apazunersen) fails Ph3 primary and secondary endpoints in Angelman syndrome study
Antisense oligonucleotide, neurological, Angelman syndrome, rare disease, GTX-102 - Read more
THE BAD
Layoffs
Novartis cuts 130 Switzerland jobs, discontinuing Kleinbasel biologics production by 2027 in strategic restructuring
Biologics, operational, cost reduction, strategic - Read more
You’re all caught up on the latest Pharma & Biotech News!
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Thanks for reading! -Anis
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