Regulatory

ICH Technology Platform Report: Secure Collaboration Requirements for Regulatory Harmonisation

This ICH Technology Task Force report confirms the value and technical feasibility of a secure, cloud-based collaboration platform to support harmonisation work. It outlines the security, governance, legal, and procurement steps needed before the ICH Management Committee can move toward an RFP.

Pharma in Focus: Regulatory Updates You Need to Know

The pharmaceutical industry faces sweeping regulatory changes that reshape drug approval timelines and increase scrutiny on clinical trial data. This article covers key takeaways from the June 2026 Temple University event and their implications for BD teams, investors, and analysts.

AstraZeneca's Camizestrant: Navigating Divergent Regulatory Paths for Breast Cancer Treatment

AstraZeneca's breast cancer drug, camizestrant, faced a significant regulatory divergence with CHMP approval in Europe contrasting with an FDA rejection. This split highlights evolving global regulatory landscapes and presents key considerations for pharmaceutical business development and investment strategies.

FDA Blueprint Aims to Reduce Regulatory Risks for Animal Testing Alternatives

The FDA has released a blueprint to reduce regulatory risks associated with alternatives to animal testing, signaling a significant shift in drug development and regulatory pathways. This initiative aims to streamline the adoption of new approach methodologies (NAMs), potentially accelerating drug approvals and influencing investment strategies.

Real-World Data from EHRs and Claims: Strengths, Limitations, and Regulatory Impact

Real-world data (RWD) from Electronic Health Records (EHRs) and claims offers significant value for pharmaceutical research and regulatory submissions. However, understanding its inherent strengths and limitations is crucial for effective utilization.

FDA's Shifting Tides: Navigating Clinical Trials Amidst Regulatory Uncertainty

The FDA is implementing a modern approach to real-time clinical trials (RTCT), allowing scientists to monitor safety signals and endpoints as trials progress. This initiative follows a period where the agency halted an average of 664 experimental drug trials annually from 2017-2021, highlighting a complex regulatory environment.

Navigating the Regulatory Landscape: A Strategic Policy Agenda for Private Equity in Healthcare

Private equity's rapid expansion in the healthcare sector has outpaced current regulatory frameworks. This article outlines a strategic policy agenda necessary to safeguard patients, providers, and the integrity of care delivery.

Eli Lilly's Retatrutide Success Amidst Regulatory Shifts: A Strategic Analysis

Eli Lilly's triple agonist, retatrutide, has achieved a significant Phase 3 win, demonstrating substantial weight loss. This success occurs against a backdrop of notable regulatory changes, impacting the pharmaceutical landscape.