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From planning and logistics to regulatory approvals and patient recruitment, immuno-oncology (IO) therapies pose unique challenges in clinical research. Discover how IQVIA Biotech’s cutting-edge approach helps biotech and emerging biopharma companies to successfully navigate IO trials and advance cancer treatments. https://bit.ly/3wAON2t #ImmunoOncology #clinicalresearch

BREAKING: Just hours before America's biggest cancer conference kicks off, a small biotech called Summit Therapeutics, Inc. made waves with new late-stage results. Summit's cancer drug beat Merck's flagship immunotherapy Keytruda in a Phase 3 lung cancer study conducted in China. That led to a multibillion-dollar stock move, with Summit gaining over $5 billion in market value on Thursday, while Merck's shares dropped just over 1%. It will also re-open contentious questions about the willingness of FDA regulators and US oncologists to rely on China-based clinical results. The success also boosts the chances of a rare repeat success in biotech for CEO Bob Duggan, who previously ran Pharmacyclics, an AbbVie Company, before selling it in 2015 for $21 billion and becoming a billionaire. My latest for Endpoints News:

Update: FDA launch a pilot program that could bypass oncology Companion Diagnostics Real-world data will play a critical role for drug manufacturers considering participation in the new FDA pilot program.   Read our latest blog by Jordan Clark, part of our executive team, and understand how leveraging real-world data (RWD) can enable drug manufacturers to navigate the pilot program to optimize the development process, enhance patient outcomes, and contribute to the advancement of cancer care.   Read the blog here: https://lnkd.in/eYmMGJAa Contact us to discuss our RWD solutions: https://lnkd.in/duuUdunz #oncology #pharmaceuticalindustry #fda #precisionmedicine #cdx #BetterTestingBetterTreatment

Our #CancerResearch approach is driven by our deep understanding of causal human biology. Leveraging our differentiated research platforms, targeted #ProteinDegradation, #CellTherapy and radiopharmaceutical therapeutics (RPTs), we’re leading the way as we work to advance transformative new treatment options for patients. Explore our approach to cancer research: https://bit.ly/3Rb1R5C #ASCO24

📢 The latest New Medicines, Novel Insights Newsletter is available now! The FDA recently required six licensed CAR-T cancer treatment manufacturers to add boxed warnings to their product labels. The requirement has implications for sponsors with approved therapies and those in development. In this edition, Parexel's Mwango Kashoki MD MPH, former Associate Director for Safety in FDA’s Office of New Drugs, shares insights and guidance to navigate this. Like and subscribe for more #NovelInsights! #FDA #oncology

📢 The latest New Medicines, Novel Insights Newsletter is available now! The FDA recently required six licensed CAR-T cancer treatment manufacturers to add boxed warnings to their product labels. The requirement has implications for sponsors with approved therapies and those in development. In this edition, Parexel's Mwango Kashoki MD MPH, former Associate Director for Safety in FDA’s Office of New Drugs, shares insights and guidance to navigate this. Like and subscribe for more #NovelInsights! #FDA #oncology

📢 The latest New Medicines, Novel Insights Newsletter is available now! The FDA recently required six licensed CAR-T cancer treatment manufacturers to add boxed warnings to their product labels. The requirement has implications for sponsors with approved therapies and those in development. In this edition, Parexel's Mwango Kashoki MD MPH, former Associate Director for Safety in FDA’s Office of New Drugs, shares insights and guidance to navigate this. Like and subscribe for more #NovelInsights! #FDA #oncology

📢 The latest New Medicines, Novel Insights Newsletter is available now! The FDA recently required six licensed CAR-T cancer treatment manufacturers to add boxed warnings to their product labels. The requirement has implications for sponsors with approved therapies and those in development. In this edition, Parexel's Mwango Kashoki MD MPH, former Associate Director for Safety in FDA’s Office of New Drugs, shares insights and guidance to navigate this. Like and subscribe for more #NovelInsights! #FDA #oncology