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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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