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Standards & Regulation

Business & Regulation COVID-19

From COVID-19 to Monkeypox

| Stephanie Sutton

It’s been a busy time for infectious disease vaccine news in Europe.

Business & Regulation Standards & Regulation

Quick-Fire Q&A: Biosimilars in the US

| Stephanie Sutton | 3 min read

Biosimilars have been available in Europe for years. Is the US still lagging behind?

Manufacture Biosimilars

Towards Better Biosimilar Access

| Maryam Mahdi | 4 min read

Though in theory, biosimilars should help improve medicines access, what challenges still stand in the way of therapeutic equality and equity?

Business & Regulation Business Practice

Moderna Begins New Search for Chief Financial Officer

| Stephanie Sutton

Moderna’s new CFO lasts one day in the job as investigation comes to light.

Business & Regulation Standards & Regulation

Medicare Reveals Coverage Policy for Amyloid mAbs

| Stephanie Sutton

Medicare publishes policy for amyloid mAbs and Alzheimer’s disease. It’s not good news for Aduhelm.

Business & Regulation Standards & Regulation

Sharing is Caring (for Animals)

| Stephanie Sutton

How an initiative from EFPIA and a new public database on chemical substances could reduce animal experiments.

Business & Regulation Technology and Equipment

The 360 Virtual Tour

| Stephanie Sutton

We find out how technology is enabling remote inspections in the pharma industry.

Manufacture Facilities

Embracing the Quality Mindset

| Mike Martin

With the FDA still behind on inspections, manufacturers need to uncover their own blindspots.

Business & Regulation Standards & Regulation

An Ode to Flexible Cleanroom Furniture

| Sue Springett

Reconfigure. Redefine. Why modular cleanroom furniture is essential for a changing pharmaceutical market.

Business & Regulation Business Practice

What’s in a Name?

| Maryam Mahdi

That which we call rosaimab by any other name would find regulatory approval and commercial success. Or would it?


Latest White Papers

Overcoming the challenges of nitrosamine impurities in drugs

| Contributed by Thermo Fisher Scientific

HRAM LC-MS method for the determination of nitrosamine impurities in drugs

| Contributed by Thermo Fisher Scientific

LC-MS/MS method for the quantification of 10 nitrosamine impurities in metformin

| Contributed by Thermo Fisher Scientific

Early stage product development using laser diffraction analysis

| Contributed by Malvern Panalytical

All White Papers

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