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Standards & Regulation

Business & Regulation Standards & Regulation

This Week’s Biopharma News: EU Launches Initiative to Attract Scientists from US

| Stephanie Vine | 4 min read

Our latest news roundup reports on Novartis’ new acquisition, an NIH grant for an Alzheimer’s disease vaccine, and more

Business & Regulation Standards & Regulation

US States Sue Over RFK Jr’s HHS Layoffs and Reorganization

| Stephanie Vine | 3 min read

Attorney Generals claim: “This administration is not streamlining the federal government; they are sabotaging it.”

Business & Regulation Business Practice

Breaking Down Brain Barriers

| Agnese Cattaneo | 3 min read

As mental health disorders escalate, pharmaceutical innovators can harness advanced tools to accelerate much-needed treatments.

Business & Regulation Trends & Forecasts

Quality Over Quantity: EMA's New Approach to Biosimilars

| Rob Coker | 2 min read

EMA reflection paper considers elimination of routine comparative efficacy studies for biosimilars.

Business & Regulation Standards & Regulation

Trump's New Push on Drug Pricing

| Rob Coker | 2 min read

Trump signs executive order on lowering drug prices and amends Medicare price negotiation for small molecule drugs.

Business & Regulation Standards & Regulation

Disrupted Development

| Rob Coker | 3 min read

The political situation in the US and its impact on science and medicine is changing rapidly. Here’s a quick look at the latest developments.

Business & Regulation Standards & Regulation

FDA to Phase Out Animal Testing

| Rob Coker | 2 min read

FDA to phase out mandatory animal testing with human-relevant methods for drug development

Business & Regulation Standards & Regulation

Trump Speech Suggests Pharma Tariffs Incoming

| Stephanie Vine | 2 min read

Donald Trump threatens “major tariff” on pharmaceuticals.

Business & Regulation Standards & Regulation

Sitting Down With… The Past: Kowid Ho

| 3 min read

We dive into the archive of 2022 for insight and inspiration – this time with Kowid Ho

Business & Regulation Standards & Regulation

Is the FDA About to Break?

| Stephanie Vine | 3 min read

Job cuts at the FDA spark concern, with Robert Califf saying the agency as we know it is “finished.”


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

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