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- Biotech & Pharma Updates | December 3 - 4, 2025
Biotech & Pharma Updates | December 3 - 4, 2025
🧬 Denali Therapeutics + Royalty Pharma strike $275M financing deal for Hunter syndrome drug tividenofusp alfa, OTR Therapeutics raises $100M Series A for advancing early-stage innovations into "globally impactful" therapies, Paradigm Health raises $78M Series B for AI-powered clinical trials platform expansion, AstraZeneca + Neurimmune partner on amyloidosis antibody NI009 in up to $780M deal, FDA approves Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) for relapsed or refractory marginal zone lymphoma, Buckland Group launches Quvara Medical CDMO after acquiring Becton Dickinson's U.K. manufacturing facility
All the top Biotech & Pharma news in one daily newsletter.
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✅ The Good News ✅
THE GOOD
Approvals & Labels
FDA approves Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) for relapsed or refractory marginal zone lymphoma
Cell therapy, cancer, CAR-T, marginal zone lymphoma, CD19 target, relapsed refractory - Read more
THE GOOD
Business Development & Partnerships
AstraZeneca, Neurimmune partner on amyloidosis antibody NI009, up to $780M deal value
Licensing deal, rare disease, antibody, milestone payments - Read more
Denali Therapeutics, Royalty Pharma strike $275M financing deal for Hunter syndrome drug tividenofusp alfa
Royalty deal, rare disease, enzyme replacement therapy, milestone payments - Read more
Crescent Biopharma, Kelun-Biotech swap ADC and bispecific therapies, $1.25B total deal value
Licensing deal, oncology, antibody-drug conjugate, bispecific antibody, milestone payments - Read more
Formycon, MS Pharma sign exclusive commercialization partnership for Keytruda biosimilar FYB206 in MENA region
Licensing deal, oncology, antibody, commercialization - Read more
Sanofi, LabGenius expand AI partnership to optimize nanobody molecules for inflammation targets
Research collaboration, autoimmune, AI/ML, antibody, drug discovery - Read more
Lupin, Valorum partner on exclusive licensing of biosimilar Armlupeg for US commercialization
Licensing deal, biosimilar, oncology, manufacturing agreement, royalties - Read more
Replicate Bioscience, Instituto Butantan collaborate on srRNA rabies vaccine RBI-4000 development in Latin America
Licensing deal, infectious disease, vaccine, self-replicating RNA, royalties - Read more
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✅ More Good News ✅
THE GOOD
Clinical Trials
CervoMed plans Ph3 trial for neflamapimod targeting dementia with Lewy bodies following improved Ph2 extension results
Small molecule, neurological, dementia with Lewy bodies, brain-penetrant, p38 MAPK inhibitor - Read more
Sobi's pegcetacoplan shows positive Ph3 results for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis
Protein therapy, kidney disease, complement inhibitor, C3 glomerulopathy, pegcetacoplan - Read more
Nationwide Children's Hospital initiates first-in-human gene therapy trial for SLC6A1-related neurodevelopmental disorder
Gene therapy, neurological, rare disease, SLC6A1, pediatric population, neurodevelopmental disorders - Read more [Paywall]
THE GOOD
Company Launches
Buckland Group launches Quvara Medical CDMO after acquiring Becton Dickinson's U.K. manufacturing facility
Medical device manufacturing, prefilled syringes, strategic, major transaction - Read more
RaptorCo launches as first on-chain longevity biotech, spun out from Curetopia DAO using AI drug discovery
Drug discovery, longevity, strategic, operational - Read more
THE GOOD
Fundraises
Paradigm Health raises $78M Series B, AI-powered clinical trials platform expansion
Clinical trial platform, AI/ML platform, oncology, services - Read more
SciNeuro raises $53M Series funding, developing drugs for Alzheimer's and Parkinson's
Neurological, Alzheimer disease, Parkinson disease, small molecule - Read more
Laigo Bio raises €11.5M ($13.4M) seed, SureTAC protein degradation platform for oncology/autoimmunity
Protein degradation, oncology, autoimmune, antibody, preclinical - Read more
OTR Therapeutics raises $100M Series A, advancing early-stage innovations into “globally impactful therapies” therapies
Immunology, oncology, platform technology, early-stage - Read more
THE GOOD
Regulatory
HHS launches OneHHS unified AI strategy integrating artificial intelligence across CDC, CMS, FDA agencies
Digital health, strategic, operational, regulatory - Read more
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❌ The Bad News ❌
THE BAD
Approvals & Labels
FDA requests more data from UniQure for AMT-130 Huntington's disease gene therapy, delaying approval timeline
Gene therapy, neurological, Huntington disease, antisense oligonucleotide, protein knockdown - Read more
THE BAD
Politics & Policy
Trump administration sets January 2029 deadline for pharma companies' "most favored nation" US investment commitments
Regulatory, strategic, major transaction, financial - Read more [Paywall]
THE BAD
Regulatory
FDA holds Denali Therapeutics's phase 1 Pompe disease trial over immune reaction concerns in preclinical studies
Enzyme replacement therapy, rare disease, regulatory, operational - Read more
FDA transfers OTC drug office director Michele amid ongoing leadership churn under RFK Jr.
OTC drugs, regulatory, operational, strategic - Read more
FDA delays releasing data on 10 alleged pediatric COVID vaccine deaths until month-end
mRNA vaccine, infectious disease, regulatory, operational - Read more
👹 The Ugly News 👹
THE UGLY
Politics & Policy
Pentagon identifies WuXi AppTec as military-linked threat despite company avoiding Biosecure Act sanctions
Contract research organization, regulatory, strategic, operational - Read more
THE UGLY
Regulatory
CDC's ACIP delays newborn hepatitis B vaccine vote again amid debate over voting language
Vaccine, infectious disease, regulatory, operational - Read more
FDA's twelve former commissioners condemn Prasad's proposed stricter vaccine review standards in medical journal
Vaccine, infectious disease, regulatory, operational - Read more
FDA names COVID vaccine skeptic Tracy Beth Høeg as acting CDER chief, fifth appointee this year
Vaccines, infectious disease, regulatory, operational - Read more
You’re all caught up on the latest Pharma & Biotech News!

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