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The Good News

THE GOOD
Approvals & Labels

MHRA approves Brinsupri (brensocatib) targeting dipeptidyl peptidase 1 for non-cystic fibrosis bronchiectasis treatment
Small molecule, respiratory disease, dipeptidyl peptidase 1 inhibitor, non-cystic fibrosis bronchiectasis - Read more

Immedica Pharma's Loargys (pegzilarginase-nbln) receives FDA accelerated approval for Arginase 1 Deficiency hyperargininemia treatment
Protein therapy, metabolic, enzyme replacement therapy, arginase 1 deficiency, hyperargininemia, pediatric patients - Read more

THE GOOD
Business Development & Partnerships

Bora Pharmaceuticals, GSK renew five-year manufacturing agreement covering 335 products worth $250M
Manufacturing agreement, infectious disease, small molecule, commercial manufacturing - Read more

Fortress Biotech sells FDA priority review voucher for $205M following Zycubo approval
Asset sale, rare disease, regulatory, milestone payments - Read more

Astellas, Vir Biotechnology partner on masked prostate cancer bispecific VIR-5500, $335M upfront, $1.7B total
Licensing deal, oncology, bispecific antibody, milestone payments - Read more

Angelini Pharma, Quiver Bioscience partner on AI-driven genetic epilepsy therapies, $120M milestones
Research collaboration, neurological, AI/ML, rare disease, milestone payments - Read more

Harbour BioMed, Solstice Oncology license anti-CTLA-4 antibody HBM4003, $105M upfront, $1.2B total
Licensing deal, oncology, antibody, milestone payments, equity investment - Read more

Frontier Biotechnologies, GSK license two siRNA products for $40M upfront, $963M milestones
Licensing deal, siRNA, milestone payments, royalties - Read more

Blackstone Life Sciences, Johnson & Johnson co-fund bleximenib clinical trials for acute myeloid leukemia
Co-funding agreement, oncology, small molecule, R&D - Read more

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More Good News

THE GOOD
Clinical Trials

Vir Biotechnology reports positive Ph1 results for VIR-5500 targeting PSMA in metastatic castration-resistant prostate cancer
Protein therapy, cancer, T-cell engager, metastatic castration-resistant prostate cancer, PSMA target - Read more

Protara Therapeutics' TARA-002 shows 68% complete response rate in Ph2 trial for non-muscle invasive bladder cancer
Cell therapy, cancer, intravesical therapy, non-muscle invasive bladder cancer, BCG-unresponsive - Read more

THE GOOD
Fundraises

Generate:Biomedicines plans $425M IPO to bankroll antibody's phase 3 asthma trials
Antibody, respiratory disease, AI-driven, CAR-T, clinical-stage - Read more

Apotex seeks $730M IPO, Canadian generic drugmaker going public 2026
Generic drugs, small molecule - Read more

THE GOOD
Investments

AbbVie invests $380M in two new North Chicago API plants for neuroscience and obesity medications
Small molecule, neurological, strategic, major transaction, operational - Read more

THE GOOD
Lawsuits

REGENXBIO wins appellate court ruling against Sarepta Therapeutics in gene therapy patent dispute over Elevidys technology
Gene therapy, rare disease, strategic, competitive - Read more

THE GOOD
Mergers & Acquisitions

Gilead to acquire CAR T partner Arcellx for $7.8B ahead of potential anito-cel approval
CAR-T, oncology, strategic, major transaction - Read more

THE GOOD
Product Launches

Promise Bio launches Frontier Epiproteomic Innovation Grant providing R&D access to epiproteomic analysis for biotech companies
Epiproteomics, immunology, strategic, operational - Read more

THE GOOD
Regulatory

FDA publishes draft guidance for personalized genetic medicines targeting rare diseases through Plausible Mechanism Pathway
Gene editing, rare disease, regulatory, strategic - Read more

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The Bad News

THE BAD
Clinical Trials

Roche halts satralizumab (anti-IL-6 receptor antibody) Ph2 study for Duchenne muscular dystrophy citing no realistic approval path
Antibody, neurological, monoclonal antibody, Duchenne muscular dystrophy, IL-6 receptor target - Read more

Gossamer Bio's seralutinib (PDGFRα/β, CSF1R, c-KIT inhibitor) fails Ph3 trial for pulmonary arterial hypertension treatment
Small molecule, cardiovascular, kinase inhibitor, pulmonary arterial hypertension, inhaled delivery, PDGFR inhibitor - Read more

Novo Nordisk's CagriSema falls short of Eli Lilly's Zepbound in Ph3 obesity head-to-head trial
Small molecule, metabolic, GLP-1 agonist, obesity, combination therapy - Read more

THE BAD
Lawsuits

Bayer sues Johnson & Johnson over allegedly false advertising claims promoting Erleada superiority over Nubeqa
Small molecule, oncology, competitive, regulatory - Read more

THE BAD
Layoffs

Bristol Myers Squibb to eliminate 247 New Jersey jobs as part of ongoing $2B restructuring effort
Operational, cost reduction, strategic, financial - Read more

THE BAD
Politics & Policy

EU pauses US trade deal affecting pharmaceutical tariffs after Supreme Court ruling, Trump threats
Pharmaceuticals, regulatory, strategic, major transaction - Read more

CDC Principal Deputy Director Ralph Abraham steps down amid ongoing leadership shake-up at agency
Infectious disease, regulatory, operational, strategic - Read more

THE BAD
Strategic Plans

Merck & Co. splits cancer, specialty drug businesses in leadership shakeup preparing for Keytruda patent cliff
Cancer immunotherapy, oncology, strategic, operational, financial - Read more

👹 The Ugly News 👹

THE UGLY
No Ugly News Today!

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