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  • Biotech & Pharma Updates | December 1 - 2, 2025

Biotech & Pharma Updates | December 1 - 2, 2025

🧬 Bipartisan lawmakers introduce bill creating US biopharma manufacturing center to reduce foreign dependence, WuXi Biologics + Qatar Free Zones Authority sign MoU to establish first Middle East CRDMO center, ARCH + Parker Institute launch Medici Therapeutics - acquiring Nutcracker's $200M RNA programs, Axoltis Pharma raises €18M ($20.9M) Series A to develop ALS drug candidate NX210c, Fractyl Health's Revita shows sustained weight maintenance post-GLP-1 discontinuation in Ph2 REVEAL-1 obesity study, Roche's trontinemab shows 92% amyloid clearance in Ph1/Ph2 trial for Alzheimer's disease, House unanimously passes bill to revive FDA's expired rare pediatric disease priority review voucher program

All the top Biotech & Pharma news in one daily newsletter.

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✅ The Good News ✅ 

THE GOOD
Business Development & Partnerships

WuXi Biologics, Qatar Free Zones Authority sign MoU to establish first Middle East CRDMO center
Manufacturing agreement, antibody, biologics, CRDMO services - Read more

THE GOOD
Clinical Trials

Vandria reports positive Ph1 results for VNA-318 in Alzheimer's disease, showing safety and target engagement
Small molecule, neurological, Alzheimer disease, dual mode of action, brain penetrant - Read more

Roche's trontinemab shows 92% amyloid clearance in Ph1/Ph2 trial for Alzheimer's disease
Antibody, neurological, monoclonal antibody, Alzheimer disease, amyloid-beta target, blood-brain barrier - Read more

Imvax seeks FDA meeting for IGV-001 personalized immunotherapy after Ph2 glioblastoma survival benefit despite endpoint miss
Antisense oligonucleotide, cancer, glioblastoma, personalized immunotherapy - Read more

Enterome's EO2401 OncoMimics immunotherapy shows survival benefit in Ph2 glioblastoma trial with nivolumab combination
Peptide therapy, cancer, OncoMimics peptides, glioblastoma, combination therapy, checkpoint inhibitor - Read more

Fractyl Health's Revita shows sustained weight maintenance post-GLP-1 discontinuation in Ph2 REVEAL-1 obesity study
Medical device, metabolic, endoscopic procedure, obesity, GLP-1 therapy, weight maintenance - Read more

Jasper Therapeutics reports positive Ph1b data for briquilimab targeting KIT in allergic asthma patients
Antibody, respiratory disease, monoclonal antibody, allergic asthma, KIT receptor, mast cell targeting - Read more

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 More Good News 

THE GOOD
Company Launches

ARCH, Parker Institute launch Medici Therapeutics, acquiring Nutcracker's $200M RNA programs
RNA therapeutics, oncology, strategic, major transaction - Read more [Paywall]

THE GOOD
Fundraises

Axoltis Pharma raises €18M ($20.9M) Series A, developing ALS drug candidate NX210c
Neurological, ALS, clinical-stage, blood-brain barrier - Read more

Metri Bio raises $5M Pre-Seed, developing therapeutics for endometriosis diseases
Women's health, platform technology, endometriosis, preclinical - Read more

HotHouse Therapeutics raises £2.9M ($3.83M) Pre-Seed, AI-powered plant bioengineering drug discovery platform
AI/ML platform, drug discovery, plant bioengineering, platform technology - Read more

THE GOOD
Market Reports

Pharma companies pledge $370B in US investments over five years amid Trump tariff policies
Manufacturing, strategic, major transaction, operational - Read more

THE GOOD
Politics & Policy

Bipartisan lawmakers introduce bill creating US biopharma manufacturing center to reduce foreign dependence
Biopharmaceuticals, strategic, regulatory, operational - Read more

THE GOOD
Regulatory

House unanimously passes bill to revive FDA's expired rare pediatric disease priority review voucher program
Rare disease, pediatric, regulatory, strategic, financial incentives - Read more

FDA proposes scaling back primate testing for antibody drugs using alternative safety assessment methods
Monoclonal antibody, regulatory, operational, cost reduction - Read more

THE GOOD
Strategic Plans

Tiziana spins out IL-6 drug TZLS-501 into separate public company citing Big Pharma interest
Monoclonal antibody, autoimmune, strategic, major transaction - Read more

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❌ The Bad News

THE BAD
Clinical Trials

Janux reports mixed Ph1 data for JANX007 PSMA x CD3 T-cell engager in castration-resistant prostate cancer
T-cell engager, cancer, bispecific antibody, prostate cancer, PSMA target - Read more

Helicore suspends Ph1 trial of HCR-188 GIP antagonist for obesity, shifts focus to preclinical incretin conjugates
Monoclonal antibody, metabolic, GIP antagonist, obesity, incretin pathway - Read more

THE BAD
Regulatory

CDC vaccine panel to review childhood immunization schedule under new chair who opposes COVID vaccines
Vaccine, infectious disease, regulatory, operational - Read more

THE BAD
Strategic Plans

Pfizer discontinues Phase 1 ulcerative colitis drug PF-07899895 citing business priorities, not safety concerns
Small molecule, autoimmune, strategic, operational - Read more

👹 The Ugly News 👹

THE UGLY
Regulatory

FDA's Richard Pazdur retires just three weeks after becoming CDER director, creating regulatory uncertainty
Regulatory, strategic, operational, leadership transition - Read more

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

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