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Standards & Regulation

Business & Regulation Standards & Regulation

Settling the PrEP Patent Disputes

| Rob Coker | 2 min read

With US courts consistently ruling in favor of the PrEP drug manufacture, the CDC and DHHS have had no choice but to be humble.

Business & Regulation Standards & Regulation

Trump 2.0

| Stephanie Vine | 3 min read

Trump withdraws the US from the WHO and pharma stakeholders call for changes to price negotiation program

Business & Regulation Standards & Regulation

Regulatory Flexibility in the Event of A Pandemic

| Rob Coker | 3 min read

Summarizing the updated lessons learned by the European Medicines Agency following the COVID-19 pandemic.

Business & Regulation Digital Technologies

How AI is Changing Medical Writing

| Emmanuel Walckenaer | 4 min read

AI solutions can help sift through clinical trial data for effective medical writing, but more people need to use it.

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.


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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