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Parexel Unveils Combined Regulatory & Access Consulting Organization
Parexel has unveiled a fully-integrated regulatory & access consulting organization “designed to optimize clinical development from the earliest stages.” The newly formed Regulatory & Access team encompasses more than 1,000 on-staff consultants worldwide, the company reports, including ~100 former regulators and HTA assessors from global agencies such as FDA, the UK’s MHRA, and NMPA in China. Paul Bridges, Senior Vice President of the new organization, commented: “Today, achieving market authorization from a regulatory agency is only the first hurdle to a new therapy reaching the market. By more holistically considering the diverse requirements of regulators, payers and patients and aligning these insights with clinical development, companies can optimize their plans to drive smarter, more efficient and patient-focused strategies, leading to faster development and improved patient access to new medicines.”
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
