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Business Practice

Manufacture Facilities

FUJIFILM Diosynth and Regeneron Sign 10-Year, $3 Billion Manufacturing Agreement

| Stephanie Vine | 2 min read

FUJIFILM Diosynth to manufacture biologics for Regeneron at new facility in Holly Springs, North Carolina.

Manufacture Contract Development Services

Partnerships To Be Precise

| Elizabeth Hickman, Dave Miller | 3 min read

In the highly regulated precision medicine development sector, the agility and expertise of a CDMO can make or break a commercial drug candidate.

Business & Regulation Standards & Regulation

Trump Speech Suggests Pharma Tariffs Incoming

| Stephanie Vine | 2 min read

Donald Trump threatens “major tariff” on pharmaceuticals.

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

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.

Manufacture Advanced Medicine

Building a Resilient CGT Workforce

| Daniel Palmacci | 3 min read

With competition for skilled employees in cell and gene therapy manufacturing high, companies need to invest in training and mentorship.

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.

Manufacture Contract Development Services

Resilient Supply Chains in an Uncertain World; View From a CDMO

| 3 min read

From geopolitical conflicts to cyber threats, CDMOs must rethink resilience.

Business & Regulation Business Practice

Biden’s Legacy; Trump’s Agenda: Part 2

| 7 min read

In part 2 of our roundtable discussion, thought leaders discuss what Trump could do for drug pricing and whether change is to be feared or embraced.

Business & Regulation Business Practice

Biden’s Legacy; Trump’s Agenda: Part 1

| 10 min read

Biden pushed drug pricing reforms, whereas Trump is known for deregulation. What does this mean for pharma?

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May Issue of The Medicine Maker