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Standards & Regulation

Business & Regulation Standards & Regulation

RFK Jr Fires CDC Vaccine Advisory Committee

| Stephanie Vine | 3 min read

All 17 members removed from advisory panel, with RFJ Jr claiming it is “plagued with conflict of interest.”

Business & Regulation Business Practice

This Week’s Biopharma News: Argentina’s WHO Exit and Sanofi Acquisition of Blueprint Medicines

| Rob Coker | 4 min read

Our latest news roundup reports on Novartis’ prostate cancer trial, Sandoz’ osteoporosis biosimilars, and more.

Business & Regulation Advanced Medicine

Preparing National Strategies for CAR T: The Latest IQVIA Report

| Rob Coker | 5 min read

The IQVIA Institute’s latest report evaluates how well seven countries are prepared to support the complex infrastructure required for CAR T therapies

Discovery & Development Clinical Trials

How Amgen Delivered a New Rare Disease Therapy

| 9 min read

We speak with experts from Amgen and Henry Ford Health about the development and approval of Uplizna for IgG4-related disease.

Business & Regulation Bioprocessing - Upstream & Downstream

Trump Administration Cans Bird Flu Vaccine Contract With Moderna

| Rob Coker | 3 min read

From bird flu to COVID-19 vaccines to alleged corruption in journals, we look into recent moves from US Health Secretary RFK Jr.

Business & Regulation Business Practice

This Week’s Biopharma News: Pfizer and Astellas Drug Improves Cancer Survival

| Rob Coker | 4 min read

Our latest news roundup reports on a new blow for Harvard, how Pfizer and Astellas’ Xtandi improves cancer survival, and more.

Business & Regulation Business Practice

Behind the Scenes of a GMP Win

| 4 min read

We ask a company about lessons learned from the GMP certification process.

Business & Regulation Business Practice

The New Age of Global, Political, and Regulatory Challenges

| 7 min read

A report attempts to unravel the many challenges that face business leaders. We discuss those inherent in the pharmaceutical industry.

Business & Regulation Business Practice

What Trump’s Latest Moves Mean for the Industry

| 6 min read

Audrey Greenberg’s latest insight on US-based manufacturing, Trump’s “Administration for A Healthy America”

Discovery & Development Translational Science

Shifting to Animal-Free Drug Development

| Tomasz Kostrzewski | 5 min read

The FDA says it wants to phase out mandatory animal testing requirements for drug approval. What comes next?


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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May Issue of The Medicine Maker