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GSK Drops TIGIT Drug, FDA Clears First At-Home Cervical Screening Device, Merck Gains Welireg Approval

Published 3 months ago • 1 min read

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FDA Approves First At-Home Cervical Cancer Screening Device

Context: Cervical cancer screening remains underutilized, particularly among women facing barriers to in-person care.

What's New? The FDA has approved the first self-collection device for HPV testing, allowing women to collect samples at home for laboratory-based cervical cancer screening.

Why it Matters? This innovation may expand access to early detection, especially in underserved populations, and marks a pivotal shift in women’s health and cancer prevention strategies.

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Merck Gains Third FDA Approval for Welireg in Cancer Indications

Context: Welireg (belzutifan) is a HIF-2α inhibitor originally developed for kidney cancer and Von Hippel-Lindau disease.

What's New? The FDA has approved Welireg for advanced renal cell carcinoma (RCC) following prior therapy, based on a pivotal trial showing strong response rates and manageable safety profile. This marks its third approved indication.

Why it Matters? The approval broadens Merck’s oncology reach and establishes Welireg as a versatile asset in the company’s renal cancer franchise, especially after its acquisition of Peloton Therapeutics in 2019.

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GSK Shuts Down TIGIT Program After Mid-Phase Survival Data Disappoint

Context: TIGIT checkpoint inhibitors have faced increasing scrutiny following a series of high-profile setbacks across the class.

What's New? GSK is discontinuing development of its TIGIT candidate belrestotug after a mid-phase trial showed no survival benefit. The move also affects partner iTeos Therapeutics, which will refocus its pipeline amid cost-cutting efforts.

Why it Matters? The failure reflects waning enthusiasm for TIGIT-targeted immunotherapies and raises questions about biomarker strategies needed to salvage this checkpoint pathway.

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Enhancing Access and Retention in Oncology Trials Through Decentralization

Context: Decentralized clinical trials (DCTs) have gained momentum, especially in oncology, where site visits can limit patient participation and diversity.

What's New? A new Fortrea whitepaper outlines how hybrid and decentralized models improve access, retention, and compliance in oncology trials, with practical insights on logistics, data capture, and patient engagement.

Why it Matters? As oncology trials grow in complexity, decentralization offers a path to broader enrollment, greater equity, and real-world relevance—key goals for modern clinical research.

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Oncology Updates — August 2025 August 2025 delivered practice-relevant oncology updates worldwide — fresh guideline shifts, pivotal trial readouts, new approvals, diagnostics/devices, and high-impact AI tools. Below is a concise, clinician-first roundup, capped with a focused deep dive on the updated ASCO NSCLC guidelines. 🎗️ 💼 Earn for training the next generation of AI tools Medical Expert Hourly contract · Remote · $130–$180 per hour Apply here Physicians, Pathologists (Health Care and...

5 days ago • 2 min read

Regeneron Acquires 23andMe Research Division for $256M in Bankruptcy Auction Context: As 23andMe navigates Chapter 11 proceedings, key assets tied to its vast genomic database and pharma partnerships have drawn industry attention. What's New? Regeneron has secured a $256 million deal to acquire 23andMe’s therapeutics subsidiary, aiming to leverage the platform’s extensive genotypic and phenotypic data to fuel its precision medicine pipeline. Why it Matters? This acquisition gives Regeneron a...

3 months ago • 1 min read

Cullinan and Taiho Reveal Positive NSCLC Data Ahead of FDA Filing Context: Cullinan Oncology and Taiho are developing CLN-081, an EGFR exon 20 insertion–targeting therapy for NSCLC—a mutation subtype with limited approved options. What's New? At ASCO, the companies presented data showing a response rate of 41% and a 12.7-month median duration of response for CLN-081. The results are expected to support an FDA submission in the second half of 2024. Why it Matters? These findings position...

3 months ago • 1 min read