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Standards & Regulation

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?

Business & Regulation Standards & Regulation

Addressing the Aduhelm Controversy

| Stephanie Sutton

What is going on with Aduhelm? And why is the drug seen by some to be controversial?

Business & Regulation Standards & Regulation

The (DILI) Model of Success

| Maryam Mahdi

An industry consortium is tackling one of pharma’s biggest drug-related challenges.

Business & Regulation Business Practice

What it takes to enable tech transfer partnerships

| Thomas Cueni

IFPMA’s Director-General, Thomas Cueni, outlines how companies worldwide can foster long-term tech transfer partnerships.

Business & Regulation Business Practice

The Road to Digital Connectivity

| Dave Tudor

It’s time for pharma companies to embrace digital technologies.

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