IQVIA Holdings | MedPath

IQVIA and Sarah Cannon Research Institute Partner to Transform Global Oncology Clinical Trials

8 days ago

• IQVIA and SCRI Development Innovations have formed a strategic collaboration aimed at revolutionizing oncology clinical trials through improved operations, faster data delivery, and accelerated patient access to advanced therapies. • The partnership combines IQVIA's global reach and experience managing 20% of U.S. oncology trials with SCRI's community oncology expertise and Accelero operational model, which streamlines trial activation and data collection. • This collaboration creates a unified, efficient model for delivering oncology trials globally, reducing vendor complexity and operational hurdles while expediting the development of innovative cancer treatments.

Landmark Science Launches Specialized RWE Solutions to Bridge Biopharma-Vendor Gap

11 days ago

• Landmark Science has emerged as a specialized provider of real-world evidence solutions, offering a high-touch approach that bridges the traditional gap between vendors and biopharma companies. • Led by CEO Shivani Aggarwal, PhD, who brings 15 years of experience from Amgen, Regeneron, and IQVIA, the company delivers tailored evidence generation services across complex therapeutic areas including hematology, oncology, and rare diseases. • The company's team of epidemiologists and statistical programmers provides comprehensive services including data landscaping, full-scale RWE studies, and advanced analytics to help clients navigate regulatory requirements with greater speed and efficiency.

Aranscia Acquires Spesana to Enhance Precision Medicine Workflow Solutions

12 days ago

• Aranscia has acquired Spesana, integrating its patient navigation and clinical decision support platform used across 140+ clinical sites, with Spesana's founder Carla Balch joining as Executive Director of Aranscia's software solutions. • The acquisition strengthens Aranscia's portfolio of precision medicine technologies, which includes 2bPrecise, YouScript, and AccessDx Laboratory, creating a comprehensive ecosystem aimed at improving clinical workflows and patient outcomes. • Spesana clients have reported a 60% improvement in appropriate precision medicine diagnostic utilization through the platform's ability to eliminate clinical overhead and process ambiguity.

SystImmune to Present Promising Data on Iza-bren for HER2-Negative Breast Cancer at ESMO Breast 2025

15 days ago

• SystImmune will present updated safety and efficacy data for izalontamab brengitecan (iza-bren), an EGFRxHER3 bispecific antibody-drug conjugate, in locally advanced or metastatic breast cancer at ESMO Breast 2025 on May 16. • Early clinical results show encouraging efficacy across all HER2 levels in HER2-negative breast cancer patients, including HER2 0 patients, suggesting potential therapeutic benefits for patients with limited treatment options. • Iza-bren, being jointly developed by SystImmune and Bristol Myers Squibb, works by blocking EGFR and HER3 signals to cancer cells while delivering a therapeutic payload that induces cancer cell death.

Ribbon Bio Strengthens Commercial Leadership with Jeff Fitzgerald Appointment as Global Sales Head Amid MiroSynth™ DNA Launch

17 days ago

• Ribbon Bio has appointed Jeff Fitzgerald as Vice President, Global Head of Sales to drive commercial growth as the company launches its first product, MiroSynth™ DNA Molecules. • Fitzgerald brings over a decade of commercial leadership experience from companies including ArcherDx and IQVIA, where he demonstrated success in scaling operations and delivering revenue growth. • MiroSynth™ DNA utilizes Ribbon Bio's proprietary algorithm-driven technology and enzymatic assembly process to deliver highly complex and accurate synthetic DNA for applications in biopharma and life sciences.

UK Government Unveils Life Sciences Strategy to Strengthen Post-Brexit Industry

a month ago

• The UK government has revealed a comprehensive life sciences strategy led by Professor Sir John Bell, aiming to strengthen the sector after Brexit through increased funding and policy reforms. • Key proposals include £160 million in new funding, improved clinical trial capabilities, implementation of the Accelerated Access Review, and benchmarking the UK to be in the top quartile for innovative medicine adoption by 2023. • Industry leaders from pharmaceutical companies, biotech firms, and healthcare organizations collaborated on the strategy, which addresses challenges in NHS funding constraints while seeking to create a globally competitive life sciences ecosystem.

FDA's Project FrontRunner Reshapes Early-Phase Oncology Drug Development Strategy

3 months ago

• The FDA's Project FrontRunner initiative aims to accelerate oncology drug development by promoting evaluation of new therapies in earlier treatment lines, marking a significant shift from traditional late-stage approaches. • Advanced trial designs, including Bayesian methodologies and adaptive protocols, are being increasingly adopted to optimize dose selection and streamline the transition to earlier-line treatment studies. • The initiative is part of the FDA's Oncology Center of Excellence's broader strategy, emphasizing diversity in clinical trials, dose optimization, and real-world evidence integration.

Novo Nordisk Launches Home Delivery Service for Wegovy at $499 Monthly for Cash-Paying Patients

3 months ago

• Novo Nordisk introduces NovoCare Pharmacy, a direct-to-patient delivery service offering all Wegovy dose strengths at $499 per month for cash-paying and eligible commercially insured patients without coverage. • The launch comes as Wegovy supply stabilizes, with FDA confirming Novo Nordisk can now meet market demand following previous shortages that limited new prescriptions since 2022. • Currently, over 55 million Americans have coverage for weight management medicines, with 90% of insured Wegovy patients paying $0-$25 monthly for their prescriptions.

Clinical Trial Industry Faces Complex Challenges in 2025: Adaptive Designs, Political Shifts, and Diversity Requirements

4 months ago

• Clinical trials are becoming increasingly complex and expensive as they target smaller patient populations and face stricter regulations, driving the need for smarter and more efficient trial designs. • Political changes, including Trump's presidency, could lead to significant regulatory shifts in the clinical trial landscape, potentially affecting approval pathways and oversight mechanisms. • New legislation like the Inflation Reduction Act is expected to impact trial initiations and drug development, while diversity guidelines from WHO, FDA, and EMA present both opportunities and challenges for patient recruitment.

FDA Updates Guidance to Enhance Diversity in Clinical Trials

5 months ago

• The FDA has updated its guidance, mandating that clinical trial sponsors create diversity action plans (DAPs) to boost the enrollment of underrepresented groups. • These DAPs are required for pivotal trials of new drugs and should include specific goals for enrollment based on age, ethnicity, sex, and race. • The updated guidance aims to ensure clinical trials better reflect the diversity of the population that will use the new therapies. • The FDA's action follows the FDORA and DEPICT Acts of 2022, which require the agency to promote diversity in clinical trial participation.

Europe's Clinical Trial Leadership Declines as China Doubles Market Share Over Past Decade

7 months ago

• New IQVIA and EFPIA study reveals European Economic Area's share of commercial clinical trials has dropped from 18% to 12%, while China's portion doubled to 18% over the past decade. • The decline translates to 60,000 fewer patients accessing trials in EEA countries and 20,000 fewer spots in EEA-only trials, significantly impacting European patients' access to innovative treatments. • Spain emerges as a bright spot in European clinical research, surpassing Germany in trial numbers through improved facilities, rapid regulatory compliance, and effective public-private collaboration models.

AI and Advanced Technologies Reshape Clinical Trial Design and Development Strategy

a year ago

• AI/ML technologies are revolutionizing clinical trial planning by analyzing vast datasets to generate predictive insights for market landscapes, pricing outcomes, and development timelines. • Pharmaceutical companies are implementing early diversity-focused strategies in trial design, utilizing patient feedback and demographic-specific insights to optimize protocol development and recruitment. • Modern clinical trials now collect triple the data compared to a decade ago, driving the adoption of comprehensive data management strategies and quality-by-design principles for improved trial execution.

Real-World Evidence Transforms Drug Development: FDA Embraces New Paradigm in Clinical Research

6 years ago

• Real-world evidence (RWE) is revolutionizing drug development by providing crucial data from patient experiences outside traditional clinical trials, helping bring safer and more effective treatments to market. • The FDA has demonstrated strong commitment to RWE adoption, exemplified by Pfizer's Ibrance receiving expanded indication for male breast cancer based solely on real-world data. • RWE is being utilized across pharmaceutical functions, from informing clinical trial design to supporting market access decisions and value-based care initiatives worldwide.