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Editor’s note (Anis): Turns out I forgot to publish Friday’s newsletter due to an absolutely hectic day 🙃 - won’t happen again!

Roche's Tecentriq (atezolizumab) receives FDA approval for muscle-invasive bladder cancer adjuvant treatment following Ph3 success
Antibody, cancer, monoclonal antibody, bladder cancer, PD-L1 inhibitor, ctDNA companion diagnostic - Read more

Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) gains FDA approval for two HER2-positive breast cancer indications following Ph3 data
Antibody-drug conjugate, cancer, breast cancer, HER2, trastuzumab deruxtecan, neoadjuvant therapy - Read more

Anthropic, Gates Foundation commit $200M to AI-driven vaccine research and global health programs
Research collaboration, AI/ML, vaccine, infectious disease, drug discovery, equity investment - Read more

Bristol Myers Squibb, Tempus AI partner to optimize clinical trial design using Lens AI analytics platform
Research collaboration, AI/ML, oncology, neurology, clinical trials, data analytics - Read more

Velocity Bioworks secures exclusive commercial license to LarmorBio's BioScan-NMR platform at pre-institutional pricing
Licensing deal, diagnostics, manufacturing, biomanufacturing - Read more

LOTTE Biologics, Ottimo Pharma expand antibody manufacturing collaboration to advance biparatopic antibody OTP-01 toward commercialization
Manufacturing agreement, antibody, oncology, commercialization, CDMO - Read more

Lupin, Celon Pharma partner to jointly develop and commercialize generic Advair Diskus DPI globally
Licensing deal, co-development, small molecule, respiratory, manufacturing agreement, commercialization - Read more

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AstraZeneca's Imfinzi (durvalumab) plus Padcev scores Ph3 win in cisplatin-ineligible muscle-invasive bladder cancer
Antibody, cancer, PD-L1 inhibitor, bladder cancer, antibody-drug conjugate, CTLA-4 inhibitor - Read more

Cabaletta Bio's (resecabtagene autoleucel) shows Ph1/Ph2 efficacy without preconditioning in pemphigus vulgaris, targeting CD19
Cell therapy, autoimmune, CAR-T, pemphigus vulgaris, CD19, preconditioning-free - Read more

Candel Therapeutics' (aglatimagene besadenovec) shows Ph3 extended benefit in intermediate- to high-risk localized prostate cancer
Gene therapy, cancer, oncolytic virus, prostate cancer, immunotherapy, radiotherapy combination - Read more

Akeso's (ligufalimab) Ph2 data show improved survival in treatment-naïve acute myeloid leukemia patients ineligible for intensive chemotherapy
Antibody, cancer, monoclonal antibody, acute myeloid leukemia, CD47, combination therapy - Read more

Eisai projects $905M in Leqembi revenues for fiscal 2026, driven by subcutaneous auto-injector launch
Monoclonal antibody, neurological, revenue impact, competitive - Read more

Create Medicines raises $122M Series B to advance in vivo CAR-T therapies
Cell therapy, oncology, autoimmune, mRNA, in vivo CAR-T, clinical-stage - Read more

Degron Therapeutics raises $40M Series A extension, advancing molecular glue platform into immunology
Oncology, autoimmune, molecular glue, small molecule, clinical-stage, platform technology - Read more

Signant Health acquires Ametris to unify eCOA and wearable data streams in clinical trials
Digital health, clinical trials technology, strategic, major transaction - Read more

NeuroVision acquires Durin Life Sciences, adding blood-based diagnostics for Alzheimer's, Parkinson's, and ALS detection
Diagnostics, neurological, strategic, major transaction - Read more

Biogen advances diranersen (BIIB080) to Ph3 for Alzheimer's disease despite Ph2 primary endpoint miss on tau targeting
Antisense oligonucleotide, neurological, Alzheimer's disease, tau protein, intrathecal delivery - Read more

Abeona Therapeutics drops eye disease gene therapies, pivots to ABO-701 PSMA-targeting T-cell therapy for prostate cancer
Cell therapy, oncology, strategic, pipeline prioritization - Read more

Over 100 biotech leaders urge Trump to appoint Richard Pazdur as next FDA chief
Regulatory affairs, oncology, strategic, operational - Read more

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Aptose Biosciences exits CG-806 blood cancer pact with CrystalGenomics amid Hanmi Pharmaceutical acquisition
Licensing deal, oncology, small molecule, acquisition - Read more

Genmab discontinues GEN1286 Ph1/2 trial in advanced solid tumors due to unfavorable benefit-risk profile
Antibody, cancer, antibody-drug conjugate, bispecific antibody, solid tumors, folate receptor alpha - Read more

REGENXBIO's RGX-202 (microdystrophin) shows Ph3 functional gains but serious adverse events cloud Duchenne muscular dystrophy data
Gene therapy, neuromuscular disease, AAV vector, Duchenne muscular dystrophy, microdystrophin, pediatric patients - Read more

Regeneron Pharmaceuticals' fianlimab plus Libtayo (cemiplimab) combo misses Ph3 primary endpoint in unresectable or metastatic melanoma
Antibody, cancer, monoclonal antibody, melanoma, LAG-3 inhibitor, PD-1 inhibitor - Read more

Novartis cuts select biomedical research roles amid ongoing company reorganization
Operational, strategic, cost reduction - Read more

Accenture report: 64% of 2024 biopharma launch delays tied to biologics manufacturing complexity
Biologics, manufacturing, operational, strategic - Read more

FDA flags BeOne Medicines' Brukinsa TV ad 'Clarity' as misleading over unsubstantiated claims
Small molecule, oncology, regulatory, competitive - Read more

FDA places full clinical hold on Aardvark Therapeutics' ARD-101 Prader-Willi program over cardiac safety concerns
Small molecule, rare disease, regulatory, financial - Read more

Alumis abandons lonigutamab TED program, exploring strategic alternatives for Amgen's Tepezza rival
Monoclonal antibody, ophthalmology, strategic, financial, competitive - Read more

FDA's CDER, CBER acting directors and chief of staff ousted following Commissioner Makary's departure
Regulatory leadership, operational, strategic - Read more

Sun Pharma recalls chemotherapy doxorubicin batch in US over glass particle contamination concerns
Small molecule, oncology, operational, regulatory - Read more

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