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FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.

FDA Approves Coherus’ Interchangeable Biosimilar for Lucentis

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Democrats approve curbs for Medicare plans, but not for commercial drug coverage. 

Senate Advances Drug Price Negotiations

The European Commission has approved AstraZeneca and Merck’s Lynparza (olaparib) as an adjuvant treatment for BRCA-mutated HER2-negative high-risk early breast cancer.

EC Approves Additional Indication for Lynparza as Adjuvant Treatment in Breast Cancer

Better clinical data are needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety. 

Top Priority for Califf Is Combatting Health Misinformation 

Pharmaceutical Technology spoke with Niamh Lynch, Executive Director, Global Head of Quality, Lonza Small Molecules, Basel about best practices for API quality and the impact of the nitrosamine contamination situation.

Industry Perspective on API Quality–A Conversation with Niamh Lynch of Lonza Small Molecules

Andrew Feilden is the European E&L strategic director for Element.

A comprehensive understanding of potential material change can mitigate its impact on patient safety.

The Impact of Material Management on Extractables and Leachables

The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients.

What Goes Wrong When API Quality is Compromised?

Brian Carlin is global manager of pharmaceutical research and development at FMC-Biopolymer (Princeton, NJ).

George Collins is vice president, Vanderbilt Chemicals LLC. 

R. Christian Moreton, PhD, is vice-president of pharmaceutical sciences at Finnbrit Consulting and a member of Pharmaceutical Technology’s editorial advisory board.

David Schoneker is president, Black Diamond Regulatory Consulting, LLC

Jennifer Putnam is AR&D supervisor II, Perrigo

Joseph Zeleznik is manager, technical & regulatory affairs at Meggle USA.

Katherine Ulman is a Global Regulatory Compliance Manager at Dow Corning.

Stacey Bremer is Director, Product Stewardship Medical at Celanese.

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.

Mitigating the Risk from Excipient Variability

Scott Weiss is vice-president of Business Development and Open Innovation at IDBS.

Successful digital transformation in biopharma requires an integrated approach to the data lifecycle.

An Integrated Approach to the Data Lifecycle in BioPharma

Andrew James is marketing director, Ellutia Limited.

Screening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.

Quality Systems