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The Good News

THE GOOD
Approvals & Labels

AstraZeneca's Imfinzi (durvalumab) wins FDA approval for BCG-naïve high-risk non-muscle-invasive bladder cancer after Ph3 win
Antibody, cancer, monoclonal antibody, bladder cancer, PD-L1 inhibitor, combination therapy - Read more

THE GOOD
Business Development & Partnerships

Pfizer, Innovent Biologics strike $10B cancer deal covering 12 ADC and multispecific antibody programs, $650M upfront
Licensing deal, oncology, antibody-drug conjugate, multispecific antibody, milestone payments, royalties - Read more

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More Good News

THE GOOD
Clinical Trials

Eli Lilly's LY4052031 shows Ph1 promise in advanced urothelial cancer, targeting Nectin-4 as potential Padcev rival
Antibody-drug conjugate, cancer, ADC, bladder cancer, Nectin-4, topoisomerase I inhibitor - Read more

Bristol Myers Squibb's (mezigdomide) slashes relapsed or refractory multiple myeloma progression risk by 52% in Ph2/Ph3 trial
Small molecule, cancer, CELMoD, multiple myeloma, protein degradation, combination therapy - Read more

Phanes Therapeutics' (spevatamig) anti-CLDN18.2/CD47 shows promising Ph2 results in metastatic pancreatic ductal adenocarcinoma
Antibody, cancer, bispecific antibody, pancreatic cancer, CLDN18.2, CD47 - Read more

Mabgeek's MG-K10 (anti-IL-4Rα monoclonal antibody) Ph3 trial meets primary endpoint for prurigo nodularis
Antibody, autoimmune, monoclonal antibody, prurigo nodularis, IL-4Rα, IL-4/IL-13 signaling - Read more

Dizal Pharma's Zegfrovy (sunvozertinib) meets Ph3 primary endpoint in first-line EGFR exon 20 non-small cell lung cancer
Small molecule, cancer, non-small cell lung cancer, EGFR exon 20 insertion, antibody, first-line therapy - Read more

THE GOOD
Fundraises

Psilera closes oversubscribed $8.8M Seed round to advance neuroplastogen PSIL-006 into clinic
Neurological, small molecule, psychedelic therapy, preclinical - Read more

Reprogram Biosciences closes $6M Seed funding for in situ cell reprogramming oncology platform
Oncology, mRNA, cell reprogramming, immunotherapy, preclinical, AI-driven - Read more

THE GOOD
Market Reports

AARP report: US brand-name drug prices rose 81% post-launch while falling 13% abroad
Small molecule, autoimmune, drug pricing, Medicare - Read more

THE GOOD
Politics & Policy

Global pharma leaders urge Japan's PM Takaichi to boost R&D investment amid China competition
Strategic, R&D investment, competitive, operational - Read more

THE GOOD
Product Launches

Samsung Bioepis launches OPUVIZ aflibercept biosimilar vial across Europe for ophthalmic conditions
Biosimilar, ophthalmology, commercial, competitive - Read more

THE GOOD
Regulatory

FDA panel recommends COVID-19 vaccines target XFG variant for 2026-2027 season
mRNA vaccine, infectious disease, regulatory, competitive - Read more

Replimune resubmits RP1 melanoma BLA for third time following major FDA leadership shakeup
Oncolytic virus, oncology, regulatory, competitive - Read more

THE GOOD
Strategic Plans

Hoth Therapeutics rebrands as Rocket One, pivots to space-based AI chip technology, sending shares sharply higher after investor enthusiasm
Small molecule, dermatology, strategic, rebranding - Read more

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The Bad News

THE BAD
Clinical Trials

Agios Pharmaceuticals' tebapivat (pyruvate kinase activator) Ph2b trial fails in lower-risk myelodysplastic syndromes
Small molecule, blood disorders, pyruvate kinase activator, myelodysplastic syndromes, sickle cell disease - Read more

THE BAD
Regulatory

FDA delays Beren Therapeutics' rare disease drug adrabetadex decision by three months to November
Small molecule, rare disease, regulatory, competitive - Read more

THE BAD
Strategic Plans

Gilead discontinues GS-0272 (MB272) Ph1 BTLA agonist program in latest blow to inflammatory disease field
Antibody, autoimmune, monoclonal antibody, BTLA agonist, rheumatoid arthritis, immune checkpoint - Read more

👹 The Ugly News 👹

THE UGLY
Regulatory

FDA issues warning letter to Alchymars over equipment disrepair, rust residues at Indian API facility
API manufacturing, regulatory, operational, compliance - Read more

You’re all caught up on the latest Pharma & Biotech News!

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