n late 2023, The Wall Street Journal published the article Generic Drugs Should Be Cheap, but Insurers Are Charging Thousands of Dollars for Them (subscription only). This article examined interactions between patient health insurance prescription benefits, pharmacies, and pharmacy benefit managers (PBMs), and their collective impact on the prices that patients pay for their prescription drugs in the United States.

he COVID-19 pandemic exposed significant challenges in the pharmaceutical global supply chain, leading to severe shortages of drugs and vaccines worldwide. This resulted in a pronounced inequity in distribution, particularly disadvantaging the Global South. This disparity is largely due to the dependency of low- and middle-income countries (LMICs) on pharmaceutical manufacturing in more industrialized nations. To mitigate this inequity and ensure supply of medicinal products across the globe, manufacturing of medicinal products needs to be decentralized through the establishment of manufacturing sites in LMICs.

n the intricate world of life sciences, where patient safety and regulatory compliance are paramount, pharmacovigilance (PV) stands as the guardian. To understand this dynamic landscape, a survey was recently conducted with a diverse pool of 100 PV professionals across the US and Europe. The findings unveiled a tapestry of compelling insights, spanning diverse themes encompassing PV team strategies, technology maturity, and the emergence of GenAI, etc. Notably, the survey (see details below) spotlighted intriguing statistics around the acceleration of automation, the embrace of AI/ML technologies, and the strategic evolution toward smart outsourcing, painting a vivid picture of the industry’s current trajectory.

ver the past decade, the importance of patient engagement (PE) has surged, reflecting a move towards integrating patient experiences and insights into research processes. This evolution aims not just to involve patients but to empower them as research partners. Concurrently, there’s a burgeoning urgency to incorporate diversity, equity, and inclusion (DEI) principles into the drug development process, though largely as a separate and distinct effort.

ccess to reliable, complete, accurate information on clinical trial results will inform the best treatment options for patients and instill greater trust between patients, healthcare providers, clinical research professionals, and the public.

Until relatively recently, information about clinical trial results was not provided in language that is clear, accessible, and easy to understand (plain language) to most patients. Instead, information was only available in scientific and technical language (e.g., peer-reviewed medical journals, professional society presentations and proceedings, and scientific and research-oriented websites).

atient engagement across the medical innovation lifecycle has accelerated rapidly in recent years. The depth and breadth of patient engagement activities are flourishing, with increasing efforts around fit-for-purpose product development, Patient Experience Data, and value for patients who have the most to gain or lose from medical innovation and access.

ue diligence is the cornerstone of the acquisition process, particularly when considering the acquisition of companies regulated by the Food and Drug Administration (FDA) like pharmaceutical, medical device, food, pharmacy, or cosmetics companies. It determines not only the risks involved in the acquisition, but also the downstream impact of the risks.

Some companies, in the haste to close a deal, may overlook the depth and breadth of FDA-related due diligence. However, this oversight can lead to severe ramifications down the road, including overpaying for a transaction, increased risk, and even inadequacy of products the acquirer thought they purchased, which may be deemed adulterated or misbranded by the FDA due to inappropriate risk assessments. Accordingly, the due diligence process is much more than a procedural step; the assessment of a company’s interactions with the FDA and compliance with FDA regulations is a critical component in assessing the value, risks, and potential of an acquisition. The following is a list of factors to explain why FDA due diligence is critical.

o support operationalization of the African Medicines Agency (AMA), the Evaluation of Medicinal Products Technical Committee (EMP-TC) has issued a Call for Industry Applications: Pilot of the Continental Listing of Medicinal Products. This pilot project has been designed to pressure test the continental procedures and processes for evaluating medicinal products developed and endorsed by the African Medicines Regulatory Harmonisation (AMRH) Steering Committee and the assembly of the 9th African Medicines Regulators Conference (AMRC).

lectronic labeling (eLabeling hereafter), or the utilization of digital labels on packaging, is an example of digital transformation for medicinal products gaining international momentum.

eLabeling benefits both users and the environment. For patients, caregivers, and healthcare professionals (HCPs), timely communication of approved and accurate product information from a trusted source has the potential to build confidence.