RNA

Is mRNA a Gene Therapy? Unpacking the Evolving Regulatory Debate

Cynthia A. Challener, Ph.D.; April Stanley, MS MBA

Pharma's Almanac

Nitrosamine Impurities

Addressing the Evolving Nitrosamine Contamination Issue

Olon

Alternative Excipient

Preparing Today for a Potential Ban on Titanium Dioxide in Pharmaceutical Drug Products

Almut von der Brelie

MilliporeSigma

Clinical Trials

Early Reports of Positive Experiences with EMA’s New Clinical Trials Information System

Kieran O’Donnell; Nicola Kidman

European DCTs

Exploring Challenges and Considerations for Operationalizing DCTs in the European Union

Kamilla Posselt

PPD, part of Thermo Fisher Scientific

Regulatory Data

Data-Based Regulatory Submissions: What DADI Means for You

Renato Rjavec

Glocalization

From Regulatory Convergence to Global Regulatory Harmonization

Cynthia A. Challener, Ph.D.; Emilie Branch; David Alvaro, Ph.D.

Pharma's Almanac

Novel Therapies

Q: What do you identify as the greatest advances that have been achieved in recent years with respect to harmonization of pharmaceutical regulations?

Pharma's Almanac

Regulatory

Are EMA and FDA Decisions Diverging?

Nice Insight

Positive Opinion

Autologous Gene Therapy Receives Positive Opinion from EMA Committee

Emilie Branch

Pharma's Almanac

Drug Development

EMA Committee Recommends Approval of Teva’s Anti-CGRP Treatment for Migraines

Emilie Branch

Pharma's Almanac

Brexit

EMA Will Soon Operate from Amsterdam

Cynthia A. Challener, Ph.D.

Pharma's Almanac

Drug Development

EMA Recommends Approval of the First Oral Drug for Sleeping Sickness

Emilie Branch

Pharma's Almanac

Biosimilars

Herceptin Biosimilar Gets Positive Opinion in Europe

Nice Insight