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THE GOOD
Approvals & Labels

FDA re-approves GSK's Blenrep targeting BCMA for relapsed multiple myeloma after three-year market withdrawal
Antibody, cancer, antibody-drug conjugate, multiple myeloma, BCMA target - Read more

THE GOOD
Business Development & Partnerships

Medivir, Biossil license remetinostat globally for cancer; $60M milestones, mid-single digit royalties
Licensing deal, oncology, small molecule, global, milestone payments - Read more

Avantor, p-Chip collaborate on smart consumables with digital tracking for clinical traceability
Co-development, cell therapy, gene therapy, manufacturing, digital health - Read more

AGC Biologics, Rarity PBC partner for RDP-101 gene therapy manufacturing for ADA-SCID "bubble baby disease”
Manufacturing agreement, rare disease, gene therapy, cell therapy - Read more

Teijin Pharma, Elevara Medicines license rheumatoid arthritis drug candidate for $30M milestones
Licensing deal, autoimmune, small molecule, milestone payments, global - Read more

BioMed X, Daiichi Sankyo launch multispecific biologics research team for immuno-oncology solid tumor treatments
Research collaboration, oncology, antibody, R&D - Read more

Sanofi, Medidata expand partnership to embed AI across clinical trial operations
Research collaboration, AI/ML, digital health, R&D - Read more

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✅ More Good News ✅

THE GOOD
Clinical Trials

Astellas' fezolinetant shows Ph4 real-world efficacy for menopause vasomotor symptoms in 900-woman study
Small molecule, women's health, neurokinin receptor antagonist, vasomotor symptoms, menopause - Read more

Ventyx VTX3232 NLRP3 inhibitor shows cardiovascular benefits in Ph2 obesity trial despite missing weight loss endpoints
Small molecule, cardiovascular, NLRP3 inflammasome, obesity, anti-inflammatory - Read more

Harbour BioMed reports positive Ph2 results for HBM4003 plus tislelizumab in microsatellite stable metastatic colorectal cancer
Antibody, cancer, monoclonal antibody, colorectal cancer, combination therapy, CTLA-4 - Read more

Silver Creek Pharmaceuticals reports positive Ph2 results for Scp776 growth factor therapy in acute ischemic stroke
Protein therapy, neurological, growth factor, acute ischemic stroke, neuroprotection - Read more

Inhibrx reports positive registrational trial results for ozekibart in advanced chondrosarcoma, meeting primary endpoint
Antibody, cancer, monoclonal antibody, chondrosarcoma, sarcoma, combination therapy - Read more

Tango reports positive Ph1/2 data for vopimetostat PRMT5 inhibitor in MTAP-deleted cancers, plans 2026 pivotal trial
Small molecule, cancer, PRMT5 inhibitor, pancreatic cancer, MTAP-deleted tumors, combination therapy - Read more

George Medicines' GMRx2 triple-combination therapy reduces recurrent stroke in Ph3 trial for intracerebral hemorrhage patients
Small molecule, cardiovascular, combination therapy, stroke, intracerebral hemorrhage, blood pressure - Read more

THE GOOD
Company Launches

Former Pfizer CSO Mikael Dolsten and Yale’s Craig Crews launch Quarry Thera to develop next-generation molecular glue therapeutics
Biotech formation, molecular glue, drug discovery, small molecule - Read more [Paywall]

THE GOOD
Earnings & Finances

Lonza credits recently acquired California biologics site for driving Q3 growth and sales rebound
Biologics, strategic, major transaction, operational, revenue impact - Read more

THE GOOD
Fundraises

Kure Cells raises $10M Pre-Series A, CAR-T cell manufacturing platform
Cell therapy, CAR-T, manufacturing, platform technology, oncology - Read more

Pinetree Therapeutics raises $47M Series B for protein degrader cancer programs
Protein degraders, cancer, platform technology, preclinical - Read more [Paywall]

Tango Therapeutics raises $210M public offering, precision cancer medicine development
Oncology, precision medicine, clinical-stage, cancer - Read more

THE GOOD
Investments

Cambrex invests $120M to expand Iowa API manufacturing facility, boosting capacity 40% amid onshoring demand
API manufacturing, strategic, operational, major transaction, financial - Read more

Galderma commits $650M through 2030 for US-based manufacturing of Nemluvio and skincare treatments
Monoclonal antibody, dermatology, strategic, major transaction, operational - Read more

SK pharmteco invests $6.1M to expand peptide manufacturing capabilities at California facility
Peptide therapeutics, precision medicine, strategic, operational, investment, manufacturing expansion - Read more

THE GOOD
Product Launches

Tahoe Therapeutics open-sources Tahoe-x1, world's largest virtual cell AI model for drug discovery
AI drug discovery, cross-platform, strategic, open source - Read more [Paywall]

THE GOOD
Regulatory

FDA releases internal drug review checklists to reduce filing delays and improve transparency for developers
Regulatory, operational, strategic, transparency - Read more

THE GOOD
Strategic Plans

Roche CEO signals continued dealmaking after $3.5B 89bio acquisition during earnings call
FGF21 analog, metabolic disease, strategic, major transaction, business development - Read more

THE BAD
Approvals & Labels

FDA issues complete response letter for Mitsubishi's ND0612 Parkinson's disease motor fluctuation treatment
Small molecule, neurological, Parkinson's disease, motor fluctuations, continuous subcutaneous infusion - Read more

FDA issues complete response letter for Sydnexis' SYD-101 atropine eye drops for pediatric myopia progression
Small molecule, ophthalmology, atropine, pediatric myopia, muscarinic antagonist - Read more

THE BAD
Clinical Trials

Regeneron halts Ph1 study of bbT369 CAR-T targeting CD79a/CD20 for B-cell non-Hodgkin's lymphoma
Cell therapy, cancer, CAR-T, non-Hodgkin lymphoma, CD20 target, CD79a target - Read more

Kala Bio collapses after failed eye disease drug trial, lender Oxford Finance seizes control
Small molecule, ophthalmology, financial, operational - Read more

THE BAD
Earnings & Finances

Roche Q3 sales miss estimates as top drugs Hemlibra, Vabysmo decline despite currency-adjusted growth
Monoclonal antibody, rare disease, financial, revenue impact, competitive - Read more

THE BAD
Market Reports

ICER report finds US drug launch prices jumped 51% from 2022-2024, outpacing inflation significantly
Pharmaceutical pricing, multiple therapeutic areas, regulatory, financial impact - Read more

THE BAD
Regulatory

FDA cites Nephron again for repeated sterility violations at generics manufacturing facility
Generic drugs, respiratory, regulatory, operational, quality control - Read more

THE BAD
Strategic Plans

Roche drops five Chugai drug candidates including Ph2 endometriosis anti-IL-8 antibody AMY109 from pipeline
Antibody, cancer, monoclonal antibody, solid tumors, endometriosis, pipeline discontinuation - Read more

THE UGLY
No Ugly News Today!

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