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Standards & Regulation

Discovery & Development Clinical Trials

Getting to First-in-Human Fast

| Asma Patel | 3 min read

How to meet the demand for first-in-human clinical trials using fit-for-phase formulation approaches.

Manufacture Facilities

Ambition, Innovation, Impact: The Future of Cleanroom Standards

| 5 min read

The rocket-fueled dreams of a young engineer applied to the cleanroom industry.

Business & Regulation Standards & Regulation

Reactions to the Nomination of Robert F Kennedy Jr. as US Health Secretary

| Stephanie Vine, Rob Coker | 5 min read

Controversial and divisive, but Kennedy’s expertise is intended for one thing: change.

Business & Regulation Standards & Regulation

Claus Zieler: Protecting Innovation in Europe

| Stephanie Vine | 6 min read

Claus Zieler from Astellas and EFPIA addresses the challenges facing innovation in Europe, including regulatory burdens and access to medicines.

Business & Regulation Standards & Regulation

Sitting Down With… The Past: Bruno Sepodes

| Jamie Irvine

We dive into the archive of 2018 for insight and inspiration – this time with Bruno Sepodes

Business & Regulation Supply Chain

Fighting the Pirates: The Rising Threat of Counterfeits

Counterfeit medicines pose a significant threat to global health. A recent study uncovers alarming facts and emphasizes the need for solutions.

Discovery & Development Drug Discovery

Addressing the Empire of Pain

| Jamie Irvine | 11 min read

How the pharma industry can help tackle the opioid crisis and advance treatments

Business & Regulation Standards & Regulation

FDA Warning Letters: September 2024 Edition

| Stephanie Vine | 3 min read

Here’s a look at recent violations cited in FDA Warning Letters: fly pupae, cross contamination, trial dosing errors, and more.

Business & Regulation Business Practice

Driving the Future of Biopharma

| Rob Coker

Biopharma companies procrastinating on sustainability measures risk falling behind, according to Cytiva’ Global Biopharma Sustainability Review.

Business & Regulation Standards & Regulation

AstraZeneca Flu Vaccine Approved For Self-Administration

| Rob Coker

AstraZeneca’s FluMist is the first flu vaccine to be approved for self-administration.

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