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Business & Regulation Standards & Regulation

FDA Warning Letters: September 2023 Edition

| Stephanie Vine | 4 min read

A look at cGMP deviations in recent warning letters, including manufacturing conducted in corridors and equipment uncleaned for 14 years.

Manufacture Bioprocessing - Upstream & Downstream

The Viral Frontier

| Natalia Elizalde | 3 min read

How can companies beat the bottlenecks in viral vector manufacturing?

Manufacture Small Molecules

Making Your Mark

| Jim Gastle, Grant Peters | 4 min read

US-based law and patenting experts offer their thoughts on IP protection in the digital age

Business & Regulation Business Practice

Pfizer Fallout

| Stephanie Vine | 3 min read

The pharma giant’s COVID-19 vaccine saved millions of lives, but the company is quickly falling from grace.

Manufacture Small Molecules

The Contaminated Childrens’ Cough Syrup Scandal

| Stephanie Vine | 4 min read

I explore recent cases of pediatric cough medicines contaminated with diethylene glycol.

Business & Regulation Standards & Regulation

Why Are Some Medicines Linked to Suicide?

| Stephanie Vine | 3 min read

The EMA is reviewing whether certain Novo Nordisk drugs are linked to suicidal thoughts

Discovery & Development Drug Discovery

A Call to Arms for Antimicrobial Resistance

| Peter Jackson | 13 min read

Investment into new antimicrobial therapies has been lacking for decades – and now we’re now paying the price.

Manufacture Technology and Equipment

Breathing Easy

| Nic Azad | 4 min read

With the right technology in place, manufacturers can avoid the supply shortfalls experienced during respiratory season

Discovery & Development Drug Discovery

Genetic Science and Sudden Infant Death Syndrome

| Stephanie Vine | 4 min read

The case of Kathleen Folbigg shows how far the field has come, but there are still no medical interventions for sudden infant death syndrome.

Business & Regulation Business Practice

Never Break the Chain

| Nadine Lampka | 5 min read

How do we prevent criminals from reusing primary packaging for counterfeit medicines? Labeling solutions and other creative concepts can help.

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