Edition #1: 9-8- 2025

Sponsor Portfolio Shifts

BioNTech & BMS push SCLC combo into Phase III
Posted September 2025
76.3% of patients saw tumor shrinkage with pumitamig/BNT327 + chemo in Phase II.
Why it matters: New IO options in small cell lung cancer could increase study demand across SCLC sites and CRO/vendor pipelines.
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Sponsor Clinical Ops Leadership Changes

Merck KGaA appoints David Weinreich as Global Head of R&D & CMO
Posted September 2025
Weinreich, MD, MBA takes the helm of Healthcare R&D at Merck KGaA.
Why it matters: Leadership shifts often lead to portfolio reprioritizations and vendor mix adjustments.
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Vendor Executive Hires

Avania expands global leadership with four senior hires
Posted September 2025
CRO Avania bolsters its medtech/device trial leadership team.
Why it matters: Expect expanded CRO capacity and potential new service offerings.
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DeepQure taps former SoniVie exec to drive growth
Posted September 2025
Early-stage medtech firm adds seasoned clinical leader.
Why it matters: Could accelerate feasibility and first-in-human trial starts.
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Partnerships

Novartis inks $2B Arrowhead deal for RNA-targeting therapy
Posted September 2025
Novartis licenses ARO-SNCA (alpha-synuclein) for Parkinson’s pipeline.
Why it matters: More RNA-driven neuro trials likely—plus biomarker and imaging demand.
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IQVIA partners with Flagship Pioneering on AI-enabled R&D
Posted September 2025
Flagship’s portfolio companies gain access to IQVIA’s data/AI platforms.
Why it matters: Could channel steady trial flow to IQVIA’s network, shaping site/vendor access.
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Site / CRO / Vendor M&A

THL Partners acquires majority stake in Headlands Research
Posted September 2025
Reports peg transaction value near $600M.
Why it matters: Consolidation of site networks means more centralized feasibilities and standardized contracting.
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Funding

NRG Therapeutics raises £50M Series B
Posted September 2025
Funds advance Parkinson’s/ALS candidate into clinic.
Why it matters: First-in-human neuro trials coming to specialty sites.
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CHARM Therapeutics closes $80M Series B
Posted September 2025
Supports development of menin inhibitor in AML.
Why it matters: Hematology trial starts and site activations likely to accelerate.
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Revalia Bio launches with $14.5M seed round
Posted September 2025
Building a “human data trial” platform for recruitment and trial design.
Why it matters: Potential new tech vendor for study planning and participant engagement.
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Regulations

FDA issues draft guidance on overall survival in oncology trials
Posted August 18, 2025
Outlines expectations for OS assessment in study design and analysis.
Why it matters: May shift statistical planning and endpoints in ongoing and upcoming oncology trials.
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