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Standards & Regulation

Manufacture Advanced Medicine

FDA or EMA Novel Drug Approvals 2024: Anagrams Edition

| Rob Coker

So you know your small molecule from your AAV, but can you unscramble the names of these 2024 novel drug approvals?

Business & Regulation Trends & Forecasts

The Opportunities to Further Advance Drug Development

| 2 min read

Alcami experts discuss what’s needed to accelerate drug development.

Business & Regulation Standards & Regulation

EFPIA Calls For Clarity Over JCA Concerns

| Rob Coker | 2 min read

EU-based associations voice concerns over joint clinical assessments and the lack of advice meetings.

Discovery & Development Clinical Trials

Getting to First-in-Human Fast

| Asma Patel | 3 min read

How to meet the demand for first-in-human clinical trials using fit-for-phase formulation approaches.

Manufacture Facilities

Ambition, Innovation, Impact: The Future of Cleanroom Standards

| 5 min read

The rocket-fueled dreams of a young engineer applied to the cleanroom industry.

Business & Regulation Standards & Regulation

Reactions to the Nomination of Robert F Kennedy Jr. as US Health Secretary

| Stephanie Vine, Rob Coker | 5 min read

Controversial and divisive, but Kennedy’s expertise is intended for one thing: change.

Business & Regulation Standards & Regulation

Claus Zieler: Protecting Innovation in Europe

| Stephanie Vine | 6 min read

Claus Zieler from Astellas and EFPIA addresses the challenges facing innovation in Europe, including regulatory burdens and access to medicines.

Business & Regulation Standards & Regulation

Sitting Down With… The Past: Bruno Sepodes

| Jamie Irvine

We dive into the archive of 2018 for insight and inspiration – this time with Bruno Sepodes

Business & Regulation Supply Chain

Fighting the Pirates: The Rising Threat of Counterfeits

Counterfeit medicines pose a significant threat to global health. A recent study uncovers alarming facts and emphasizes the need for solutions.

Discovery & Development Drug Discovery

Addressing the Empire of Pain

| Jamie Irvine | 11 min read

How the pharma industry can help tackle the opioid crisis and advance treatments


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

All White Papers

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