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THE GOOD
Approvals & Labels

FDA approves J&J's Inlexzo, first extended-release gemcitabine system for BCG-unresponsive bladder cancer
Small molecule, cancer, drug-release system, bladder cancer, non-muscle invasive bladder cancer, extended local delivery - Read more

THE GOOD
Business Development & Partnerships

Eli Lilly opens AI drug discovery platform TuneLab to biotech startups, offering access to proprietary molecular data
AI/ML, drug discovery, research collaboration, small molecule, antibody, data analytics - Read more 

Samsung Biologics, unnamed US pharma company sign $1.3B contract manufacturing deal through 2029
Manufacturing agreement, biologics, CDMO, US-Korea, contract manufacturing - Read more

Quotient Sciences, CPI partner to accelerate RNA drug development through integrated manufacturing and clinical testing platform
Joint venture, RNA-based drug development, mRNA therapeutics, manufacturing, R&D - Read more

Kytopen, BlueWhale Bio partner to develop non-viral manufacturing workflow for cell therapies, accelerating delivery timeline
Co-development, cell therapy, manufacturing, oncology, technology focus - Read more

Tolerance Bio, ZipCode Bio partner to develop RNA-delivered thymus therapeutics for immune disorders
Research collaboration, autoimmune, RNA delivery, thymus therapeutics, immune aging - Read more

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THE GOOD
Clinical Trials

Amgen, Kyowa Kirin's rocatinlimab (OX40 receptor) shows sustained efficacy in Ph3 atopic dermatitis extension trial
Monoclonal antibody, autoimmune, atopic dermatitis, OX40 receptor, T-cell therapy, moderate to severe - Read more

J&J's RYBREVANT (amivantamab) plus LAZCLUZE reduces EGFR resistance in Ph3 trial for advanced non-small cell lung cancer
Antibody, cancer, monoclonal antibody, non-small cell lung cancer, EGFR inhibitor, combination therapy - Read more

IDEAYA's Ph2 darovasertib shows 76% tumor shrinkage in uveal melanoma, targeting PKC in neoadjuvant setting
Small molecule, cancer, kinase inhibitor, uveal melanoma, PKC inhibitor, neoadjuvant therapy - Read more

THE GOOD
Company Launches

Ridge Biotechnologies launches with $25M seed funding from Sutter Hill to advance AI-driven precision enzyme and drug design technology
Platform technology, AI/ML platform, protein design, ADC, bioconjugation, drug discovery - Read more

THE GOOD
Fundraises

Alchemab Therapeutics raises $32M Series A extension, advancing AI-enabled antibody platform for ALS
Neurological, antibody, AI/ML platform, ALS, preclinical, platform-enabled - Read more

bYoRNA raises €1.5M ($1.76M) pre-seed for innovative yeast-based mRNA production platform
mRNA manufacturing, platform technology, CDMO, fermentation technology - Read more

iRegene Therapeutics raises $40M Series B+ for iPSC-derived cell therapies for Parkinson's disease
Neurological, cell therapy, Parkinson disease, iPSC platform, clinical-stage - Read more

THE GOOD
Lawsuits

Regeneron settles with Sandoz, allowing Eylea biosimilar launch by 2026's end
Biosimilar, ophthalmology, legal settlement, regulatory, competitive - Read more

THE GOOD
Market Reports

Eli Lilly and Novo Nordisk obesity drugs deemed "highly cost-effective" by ICER despite budget strain concerns
GLP-1 agonist, obesity, cost-effectiveness, payer impact, financial, regulatory - Read more

THE GOOD
Mergers & Acquisitions

Novartis to acquire Tourmaline Bio for $1.4 billion, gaining promising IL-6 targeting cardiovascular drug pacibekitug
Anti-inflammatory drug, cardiovascular, major transaction, strategic acquisition - Read more

THE GOOD
Politics & Policy

Trump plans to exempt select pharmaceutical products from tariffs in future trade deals
Pharmaceutical policy, trade policy, strategic, regulatory impact - Read more [Paywall]

THE GOOD
Regulatory

Althera Laboratories secures GMP approval for manufacturing facility capable of producing one billion annual doses
Small molecule, cardiovascular, manufacturing, operational, regulatory - Read more

THE GOOD
Regulatory

Permira exploring $4B sale of CDMO Cambrex to private equity buyers amid onshoring trend
Acquisition, manufacturing, CDMO, private equity, US, onshoring - Read more

THE BAD
Layoffs

Lundbeck exits 27 markets, lays off 602 staff in major restructuring to focus resources on growth areas
Neurological, strategic, operational, cost reduction, resource reallocation - Read more

THE BAD
Politics & Policy

MAHA Commission releases second report targeting chronic disease and vaccine safety concerns
Vaccine policy, chronic disease, regulatory, public health - Read more

THE BAD
Regulatory

FDA misinterpreted deramiocel data, Capricor claims; company disputes DMD therapy rejection reasons
Cell therapy, muscular dystrophy, regulatory, clinical trial data - Read more

FDA closes advertising loophole requiring clearer side effect disclosures under new White House order
Regulatory, pharmaceutical advertising, operational, compliance - Read more [Paywall]

THE UGLY
No Ugly News Today!

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