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Business & Regulation

Business & Regulation Trends & Forecasts

Predictions for Pharma’s Future

| 4 min read

Looking ahead to the next 5–10 years, what will be the key disruptors and/or what can be improved upon in the pharma industry?

Business & Regulation Trends & Forecasts

The Economics of Biosimilars

| Stephanie Vine | 7 min read

We ask James Chambers from Tufts Medical Center about the challenges faced by biosimilars in the US.

Business & Regulation Standards & Regulation

Sitting Down With… The Past: Peter Marks

| 3 min read

We dive into the archive of 2021 for insight and inspiration – this time with Peter Marks

Business & Regulation Business Practice

The Trump Effect on Cell and Gene: Science versus Shockwaves

| 9 min read

Audrey Greenberg on FDA staffing cuts, Peter Marks’ resignation, CDMO pressure, IP migration, AI acceleration, and what CGT needs now to stay on track

Business & Regulation Standards & Regulation

Vaccines and Autism: Perpetuating a Populist Agenda

| Rob Coker | 3 min read

Rumours claim that a well-known vaccine skeptic has been appointed to lead study on links between vaccines and autism.

Business & Regulation Standards & Regulation

Peter Marks Resigns from FDA

| Stephanie Vine | 3 min read

Resignation letter states: “truth and transparency” around vaccines are not desired by Health Secretary RJK Jr.

Business & Regulation Digital Technologies

AI, Big Data, and Digital Disruption

| Rob Ellison | 7 min read

An industry survey looks at changing attitudes and challenges in digital innovation for clinical research. Uptake is slow but steady.

Business & Regulation Standards & Regulation

The Future of the NIH

| Hernan Bazan | 2 min read

Thoughts on the US National Institutes of Health and its role in funding research for non-opioid therapeutics.

Business & Regulation Business Practice

Calling Out Misleading Information

| Rob Coker | 2 min read

FDA letter sent to Edenbridge Pharmaceuticals demonstrates the challenges of getting pharma advertising right.

Business & Regulation Advanced Medicine

We Need to Talk About CRISPR

| 4 min read

Neal Baer, editor of a collection of essays on CRISPR, says we must not overlook the dark side of the technology.

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