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THE GOOD
Approvals & Labels

Amgen, AstraZeneca's Tezspire gets FDA approval for TSLP inhibition in chronic rhinosinusitis with nasal polyps
Antibody, autoimmune, monoclonal antibody, chronic rhinosinusitis with nasal polyps, TSLP inhibitor - Read more

FDA expands Novo Nordisk's Rybelsus GLP-1 label for cardiovascular risk reduction in type 2 diabetes
Small molecule, cardiovascular, GLP-1 receptor agonist, type 2 diabetes, oral formulation - Read more

THE GOOD
Business Development & Partnerships

Roche, Hansoh partner on colorectal cancer ADC HS-20110, $80M upfront, $1.45B milestones
Licensing deal, oncology, antibody-drug conjugate, milestone payments, global - Read more

Chugai, Rani Therapeutics partner on $1.1B oral biologics development using RaniPill capsule technology
Licensing deal, rare disease, antibody, milestone payments, drug delivery technology - Read more

Taiho Pharmaceutical exercises option to license Arcus Biosciences’ HIF-2α inhibitor casdatifan for development and commercialization in Japan and Asia
Licensing deal, oncology, small molecule, milestone payments - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

AstraZeneca's Imfinzi shows 32% risk reduction in Ph3 trial for high-risk non-muscle invasive bladder cancer
Antibody, cancer, PD-L1 inhibitor, bladder cancer, immunotherapy - Read more

AstraZeneca, Daiichi Sankyo's Datroway beats Gilead's Trodelvy in Ph3 TROP2 triple-negative breast cancer trials comparison
Antibody-drug conjugate, cancer, TROP2 ADC, triple-negative breast cancer, comparative efficacy, first-line treatment - Read more

Merck & Co.'s Keytruda plus Pfizer-Astellas' Padcev cut death risk 50% in Ph3 muscle-invasive bladder cancer trial
Antibody, cancer, PD-1 inhibitor, bladder cancer, combination therapy, perioperative treatment - Read more

AstraZeneca, Daiichi's Enhertu shows superior Ph3 results targeting HER2 in early breast cancer treatment
Antibody-drug conjugate, cancer, breast cancer, HER2-positive, adjuvant therapy, neoadjuvant therapy - Read more

Bristol Myers Squibb's izalontamab brengitecan shows 55% response rate targeting EGFR/HER3 in solid tumors Ph1 trial
Antibody-drug conjugate, cancer, ADC, non-small cell lung cancer, EGFR target, HER3 target - Read more

Pfizer's Ponsegromab shows sustained weight gains in Ph2 cancer cachexia trial at one year
Antibody, cancer, monoclonal antibody, cachexia, GDF-15 target - Read more

Novartis' Pluvicto reduces progression risk 28% in Ph3 trial for metastatic hormone-sensitive prostate cancer
Radioligand therapy, cancer, lutetium-177, prostate cancer, PSMA target, combination therapy - Read more

GSK partner Hansoh reports 49% response rate for B7-H4 ADC GSK5733584 in Ph2 ovarian cancer trial
Antibody-drug conjugate, cancer, ovarian cancer, sarcoma, B7-H4 target, B7-H3 target - Read more

Tubulis' TUB-040 NaPi2b-targeting ADC achieves 59% response rate in Ph1/2a ovarian cancer trial
Antibody-drug conjugate, cancer, ovarian cancer, non-small cell lung cancer, NaPi2b target - Read more

AstraZeneca reports 56% response rate with in-house ADC AZD5335 targeting folate receptor alpha in Ph1/2a ovarian cancer trial
Antibody-drug conjugate, cancer, ADC, ovarian cancer, folate receptor alpha target - Read more

Roche giredestrant/everolimus reduces progression risk 62% in Ph3 estrogen receptor-positive HER2-negative breast cancer trial
Small molecule, cancer, selective estrogen receptor degrader, breast cancer, ER-positive HER2-negative, ESR1 mutation - Read more

AstraZeneca's Imfinzi shows 22% death risk reduction in Ph3 trial for early gastric cancer
Antibody, cancer, monoclonal antibody, gastric cancer, PD-L1 inhibitor, perioperative treatment - Read more

Akeso's Cadonilimab shows 39% death risk reduction in Ph3 gastric cancer trial final analysis
Antibody, cancer, bispecific antibody, gastric cancer, PD-1/CTLA-4, first-line treatment - Read more

Vivace's VT3989 achieves 32% response rate in Ph2 mesothelioma trial, advancing to Ph3 in 2026.
Small molecule, cancer, mesothelioma, first-in-class - Read more

Evaxion reports 75% response rate for EVX-01 personalized cancer vaccine in Ph2 advanced melanoma trial
Vaccine, cancer, personalized cancer vaccine, melanoma, combination therapy - Read more

Summit, Akeso's Ivonescimab PD-1/VEGF antibody cuts progression risk 40% versus tislelizumab in Ph3 squamous non-small-cell lung cancer trial
Antibody, cancer, dual PD-1/VEGF antibody, non-small cell lung cancer, combination therapy, first-line treatment - Read more

Lilly's Verzenio shows 15.8% death risk reduction in Ph3 early hormone receptor-positive breast cancer trial
Small molecule, cancer, CDK4/6 inhibitor, breast cancer, overall survival - Read more

THE GOOD
Fundraises

Human Life CORD raises $7.2M additional funding, phase III cell therapy trials
Cell therapy, clinical-stage, manufacturing, pulmonary complications - Read more

Praxis Precision Medicines announces proposed public offering for CNS disorder therapies
neurological, CNS disorders, clinical-stage, precision medicine - Read more

atai Life Sciences raises $130M public offering, advancing clinical-stage mental health treatments
Clinical-stage, mental health, biopharmaceutical - Read more

THE GOOD
Mergers & Acquistions

Xoma lowers Lava Therapeutics buyout offer to $1.04 per share, extends deal deadline to November
Bispecific antibody, oncology, strategic, major transaction - Read more

THE GOOD
Politics & Policy

EMD Serono joins Trump's MFN pricing program, offering 84% discount on IVF drugs through TrumpRx platform
Recombinant protein, fertility/reproductive health, strategic, cost reduction, regulatory - Read more

THE GOOD
Regulatory

FDA awards first Commissioner's Priority Vouchers to Regeneron, Sanofi, Disc Medicine, eight others for expedited review
Gene therapy, rare disease, regulatory, strategic, competitive - Read more

THE GOOD
Strategic Plans

I-Mab rebrands as NovaBridge Biosciences, pursues Hong Kong IPO while maintaining Nasdaq listing
Biopharmaceutical platform, strategic, financial, major transaction, operational - Read more

Vimy Pharma plans made-in-Canada generic Ozempic launch next year pending Health Canada approval
Small molecule, metabolic disease, strategic, operational, competitive - Read more

THE BAD
Approvals & Labels

Sanofi's Rezurock rejected by Europe's CHMP for chronic graft-versus-host disease treatment
Small molecule, rare disease, regulatory, strategic - Read more

Xbrane receives second FDA rejection for ranibizumab biosimilar over manufacturing site inspection issues
Monoclonal antibody biosimilar, ophthalmology, regulatory, operational - Read more

THE BAD
Business Development & Partnerships

Astellas declines Taysha Gene Therapies' TSHA-102 gene therapy option for Rett syndrome
Licensing deal, rare disease, gene therapy, neurological - Read more

THE BAD
Clinical Trials

AstraZeneca's Imfinzi-Lynparza combo misses overall survival goal in Ph3 ovarian cancer trial
Antibody, small molecule, cancer, ovarian cancer, PARP inhibitor, combination therapy - Read more

THE BAD
Politics & Policy

Trump promises $150 Ozempic pricing through negotiations; Novo Nordisk drops 3%, Lilly falls 2.5%
GLP-1 agonist, diabetes, regulatory, cost reduction, competitive - Read more

THE UGLY
No Ugly News Today!

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