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Standards & Regulation

Business & Regulation Supply Chain

Where Have All the Drugs Gone?

| 6 min read

Drug shortages are everywhere. We speak with Vimala Raghavendran at the US Pharmacopeia to get the full picture.

Business & Regulation Business Practice

Why Pharma Must Embrace AI and Open Source

| Brendan Frey | 4 min read

With open minds and open sources, the future is foundational – and bright.

Business & Regulation Standards & Regulation

EMA: No to Lecanemab

| Stephanie Vine | 3 min read

Lecanemab is refused marketing authorization by the European Medicines Agency.

Business & Regulation Standards & Regulation

The Choice: To Be Cured or to Have Children?

| Stephanie Vine

Fertility support programs for gene therapy Medicare patients are being blocked in the US.

Business & Regulation Standards & Regulation

Starting with the End in Mind

| Drew Hope | 7 min read

Collaboration and thoughtful automation at scale will be critical for unlocking cell and gene therapies for patients

Business & Regulation Supply Chain

Political Change Around China Means Change for Pharma

| Kerry Pickstone | 4 min read

Why companies must tighten their supply chains in light of Chinese anti-espionage laws and other regulatory clampdowns.

Business & Regulation Business Practice

Counterfeit Medicines: Getting On The Right Track

| 5 min read

Counterfeit deterrents are not yet available in some regions. We speak with Advanco CEO Alf Goebel to find out why.

Discovery & Development Ingredients

USP: A Mission Focused on Quality and Safety

| Chaitanya Koduri | 11 min read

Following on from deaths attributed to contaminated medicines, here’s how the US Pharmacopeia is promoting testing for DEG and EG.

Business & Regulation Advanced Medicine

Changing Regulation Around ATMPs in Europe

| Jamie Irvine | 4 min read

Preparing for the EU’s new HTA regulation and Joint Clinical Assessment process

Business & Regulation Standards & Regulation

Saying Farewell to the Famous Horse Tweet

| Stephanie Vine | 5 min read

Why the FDA must delete its statement that people are not horses (or cows), referring to ivermectin use

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