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  • Biotech & Pharma Updates | November 20 - 23, 2025

Biotech & Pharma Updates | November 20 - 23, 2025

🧬 Eli Lilly becomes first pharmaceutical company to reach $1 trillion market valuation milestone, FDA approves Pfizer's Padcev and Merck & Co.'s Keytruda combo for perioperative muscle-invasive bladder cancer treatment, AstraZeneca invests $2B to expand Maryland manufacturing capacity and adding 300 jobs across two facilities, AGC Biologics + AAVantgarde manufacturing partnership for dual-vector gene therapies targeting inherited retinal disorders, Bayer's asundexian meets Ph3 endpoints for secondary stroke prevention Sorcero raises $42.5M Series B for AI-powered intelligence platform for life sciences, FDA to hire 1,000+ staff & launches communication program to accelerate drug review process

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✅ The Good News ✅ 

THE GOOD
Approvals & Labels

FDA approves Pfizer's Padcev and Merck & Co.'s Keytruda combo for perioperative muscle-invasive bladder cancer treatment
Antibody, cancer, monoclonal antibody, muscle-invasive bladder cancer, perioperative treatment, combination therapy - Read more

THE GOOD
Business Development & Partnerships

Roche, Freenome partner on cancer screening commercialization outside US, $75M investment, $200M+ potential
Licensing deal, oncology, diagnostics, equity investment - Read more

AGC Biologics, AAVantgarde manufacturing partnership for dual-vector gene therapies targeting inherited retinal disorders
Manufacturing agreement, gene therapy, rare disease, ophthalmology - Read more

Onco-Innovations, Dalton Pharma Services advance PNKP inhibitor manufacturing scale-up for Phase 1 studies
Manufacturing agreement, oncology, small molecule, drug discovery - Read more

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 More Good News 

THE GOOD
Clinical Trials

Pasithea's PAS-004 MEK inhibitor shows partial response in Ph1 advanced solid tumors trial
Small molecule, cancer, MEK inhibitor, neurofibromatosis, MAPK pathway - Read more

Bayer's asundexian meets Ph3 endpoints for secondary stroke prevention, preparing global regulatory submissions
Small molecule, cardiovascular, factor XIa inhibitor, ischemic stroke, secondary prevention - Read more

Blue Lake Biotechnology resumes BLB201 Ph1/2a enrollment in respiratory syncytial virus-negative toddlers after FDA hold lifted
Vaccine, infectious disease, viral vectored vaccine, respiratory syncytial virus, pediatric population, parainfluenza virus 5 - Read more

THE GOOD
Earnings & Finances

Eli Lilly becomes first pharmaceutical company to reach $1 trillion market valuation milestone
GLP-1 receptor agonist, diabetes, financial, major transaction, competitive - Read more

THE GOOD
Fundraises

Sorcero raises $42.5M Series B, AI-powered intelligence platform for life sciences
AI/ML platform, data analytics, software platform, life sciences services - Read more

Olema Oncology raises $218.5M public offering, breast cancer targeted therapies
Oncology, breast cancer, clinical-stage, targeted therapies - Read more

ARPA-H launches $100M EVIDENT initiative targeting rapid-acting mental health therapeutics including psychedelics
Psychedelics, neurological, strategic, major transaction - Read more

Inhibikase raises $100M public offering, developing therapeutics for pulmonary arterial hypertension
Clinical-stage, pulmonary arterial hypertension, small molecule - Read more

THE GOOD
Investments

AstraZeneca invests $2B to expand Maryland manufacturing capacity, adding 300 jobs across two facilities
Biologics, rare disease, manufacturing expansion, major transaction - Read more

THE GOOD
Marketing

Novo Nordisk forces Pennsylvania telehealth company Regen Doctors to drop compounded semaglutide claims
GLP-1 receptor agonist, metabolic disease, competitive, strategic - Read more

THE GOOD
Regulatory

FDA to hire 1,000+ staff, launches communication program to accelerate drug review process
Regulatory, operational, strategic, financial - Read more

Sangamo accelerates Fabry gene therapy filing to Q4 2025 after FDA approves rolling BLA submission
Gene therapy, rare disease, regulatory, strategic, financial - Read more

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❌ The Bad News

THE BAD
Clinical Trials

Johnson & Johnson discontinues tau-targeting posdinemab Ph2b study in mild Alzheimer's disease after missing primary endpoint
Antibody, neurological, monoclonal antibody, Alzheimer disease, tau protein, phosphorylated tau - Read more

Sarepta Therapeutics terminates Elevidys trial with Hansa Biopharma's imlifidase for Duchenne muscular dystrophy after enrolling five patients
Gene therapy, neurological, Duchenne muscular dystrophy, enzyme therapy, immunogenicity - Read more

THE BAD
Lawsuits

GSK and AnaptysBio file competing lawsuits over Jemperli licensing deal breach allegations
Monoclonal antibody, oncology, strategic, major transaction - Read more

Texas sues Sanofi, Bristol Myers Squibb over allegedly deceptive Plavix marketing to minorities
Small molecule, cardiovascular, financial, major transaction - Read more

THE BAD
Layoffs

Nurix cuts workforce after launching pivotal BTK degrader trial for relapsed leukemia patients
Small molecule, oncology, cost reduction, operational - Read more

THE BAD
Mergers & Acquisitions

Australian government blocks Cosette's $430M Mayne Pharma acquisition on national interest grounds
Women's health, regulatory, strategic, major transaction - Read more

THE BAD
Regulatory

FDA investigating pediatric death linked to Takeda's Adzynma enzyme replacement therapy for rare blood disorder
Enzyme replacement therapy, rare disease, regulatory, operational - Read more

Biotech CEOs urge FDA Director Makary for regulatory stability amid innovation investment concerns
Regulatory, strategic, operational, financial - Read more

CDC orders end to all monkey research by year-end, impacting 200 macaques and infectious disease studies
Animal research, infectious disease, regulatory, operational - Read more

👹 The Ugly News 👹

THE UGLY
No Ugly News Today!

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

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