The Medicine Maker | Standards & Regulation

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Moving Beyond Document-Based Validation

July 2, 2026

How UCB is improving traceability, audit readiness, and visibility.

1 min read

Bioprocessing Interviews Technology & Manufacturing Digital Technologies Quality & Compliance Regulation & Standards Sponsored

How Zealand Pharma Is Scaling Quality Without Complexity

June 29, 2026

How connected quality systems can help growing biotechs remain agile.

0 min read

How Zealand Pharma Is Scaling Quality Without Complexity

RFK Jr Fires CDC Vaccine Advisory Committee

By Stephanie Vine

June 10, 2025

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

3 min read

RFK Jr Fires CDC Vaccine Advisory Committee

Business & Trends Regulation & Standards

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

By Rob Coker

June 6, 2025

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

4 min read

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

Cell & Gene Regulation & Standards Business & Trends

Preparing National Strategies for CAR T: The Latest IQVIA Report

By Rob Coker

June 5, 2025

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

5 min read

Preparing National Strategies for CAR T: The Latest IQVIA Report

Development & Clinical Drug Discovery Research News Regulation & Standards Business & Trends Interviews

How Amgen Delivered a New Rare Disease Therapy

June 2, 2025

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

9 min read

How Amgen Delivered a New Rare Disease Therapy

Bioprocessing Biopharma Regulation & Standards Business & Trends

Trump Administration Cans Bird Flu Vaccine Contract With Moderna

By Rob Coker

May 30, 2025

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

3 min read

Trump Administration Cans Bird Flu Vaccine Contract With Moderna

Business & Trends Regulation & Standards

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

By Rob Coker

May 30, 2025

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

4 min read

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

Business & Trends Regulation & Standards Interviews

Behind the Scenes of a GMP Win

May 29, 2025

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

4 min read

Business & Trends Regulation & Standards Supply Chain Interviews

The New Age of Global, Political, and Regulatory Challenges

May 28, 2025

A report attempts to unravel the many challenges that face business leaders. We discuss those inherent in – and unique to – the pharmaceutical industry, from supply chains to tariffs, and more.

7 min read

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