Articles by Sean Milmo - Pharmaceutical Technology

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Articles by Sean Milmo

EU Sets Guidelines for Biosimilar Monoclonal Antibodies

The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on biosimilar monoclonal antibodies (mAbs).
Nov 2, 2012

The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on biosimilar monoclonal antibodies (mAbs).

Report from Turkey

Nov 2, 2012

The government of Turkey is drawing up a program in coordination with the pharmaceutical industry to create ways to make the country a regional production center for pharmaceuticals serving Europe, Central Asia, and the Middle East.

Report from Europe

EMA and MHRA provide insight into increased GMP deficiencies.
Jul 2, 2012

EMA and MHRA provide insight into increased GMP deficiencies.

Report from Poland

Poland's government aims to make the Eastern European country a biotech powerhouse.
May 2, 2012

Poland's government aims to make the Eastern European country a biotech powerhouse.

Report from Europe

The European Union market takes steps toward continuous processing and modular facilities.
Jan 2, 2012

The European Union market takes steps toward continuous processing and modular facilities.

Report from Russia

Russia is aiming to provide an alternative to China and India for drug manufacturing, including APIs.
Nov 2, 2011

Russia is aiming to provide an alternative to China and India for drug manufacturing, including APIs.

Report from Europe

Member states in the EU are working to implement the newly passed Falsified Medicines Directive.
Jul 2, 2011

Member states in the EU are working to implement the newly passed Falsified Medicines Directive.

Report from Hungary

Eastern Europe's pharmaceutical leader, Hungary, is working to maintain its number-one status while also pursuing new avenues, especially in biopharmaceuticals.
May 2, 2011

Eastern Europe's pharmaceutical leader, Hungary, is working to maintain its number-one status while also pursuing new avenues, especially in biopharmaceuticals.

Report from Europe

The European Commission and Medicines Agency seem to be moving in advance of their ICH partners to update standards.
Jan 2, 2011

The European Commission and Medicines Agency seem to be moving in advance of their ICH partners to update standards.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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