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Standards & Regulation

Business & Regulation Business Practice

Here Come the Humira Biosimilars

| Stephanie Vine | 2 min read

The first Humira biosimilar in the US is here, but market penetration could be a challenge.

Manufacture Facilities

Manufacturing a Fairer Future

| Angus Stewart | 6 min read

New technologies offer cheaper modes of manufacture – here’s how and why the world’s less wealthy countries could seize the moment.

Business & Regulation COVID-19

COVID-19: Anti-Vaccine Activists Sue Media Outlets

| Stephanie Vine | 3 min read

Anti-vaccine activists are suing a number of prominent media outlets, including Reuters, the Washington Post, the BBC, and the Associated Press.

Manufacture Advanced Medicine

Cell and Gene: Generating the Next Generation

| Angus Stewart | 4 min read

What can cell and gene do to avoid a seemingly inevitable rush on supporting products and services?

Manufacture Advanced Medicine

The Cords that Bind

| Angus Stewart | 4 min read

Why critical starting materials are crucial to the production of cell and gene therapies, and among them cord blood deserves particular attention

Business & Regulation Trends & Forecasts

Video Roundtable: Cell & Gene in a World in Turmoil

| Angus Stewart

In the face of economic uncertainty in a post-pandemic world, how will the cell and gene field respond?

Manufacture Advanced Medicine

Cell and Gene Champions Speak Up

| Angus Stewart

Get a sharp perspective on the cell and gene status quo in The Medicine Maker 2022 supplement on advanced medicine

Business & Regulation Standards & Regulation

Stem Cell Therapy’s Unwelcome Surprise

| Angus Stewart | 9 min read

After years of progress in the courts, could one verdict in California give unproven stem cell clinics an unwelcome boost?

Business & Regulation Standards & Regulation

Data Discussions

| Stephanie Vine | 2 min read

How a new working group plans to overcome the problem with in vitro pharmacology data.

Business & Regulation Standards & Regulation

Amazon’s FDA Warning Letters

| Stephanie Vine | 2 min read

Unregulated drugs being sold and distributed by the online retailer come under fire.

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