Articles by Stephanie Sutton - Pharmaceutical Technology

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Articles by Stephanie Sutton

EMA Strengthens Oversight on Clinical Trials

Apr 19, 2012

The European Medicines Agency (EMA) has published the final reflection paper concerning ethical and good clinical practice (GCP) aspects of clinical trials.

Illumina Urges Shareholders to Reject Roche Offer

Apr 12, 2012

Illumina has sent a fourth letter to shareholders urging them to reject Roche's offer of $51 per share, which Illumina claims is opportunistic and undervaluing the company.

Research Project Targets Tablet Sticking

Apr 6, 2012

As part of an ongoing collaboration into tabletting science, I Holland and the UK's University of Nottingham have launched a two-year programme to investigate the cause of tabletting sticking.

UK Invests in Regenerative Medicine

Apr 5, 2012

An initiative in the UK will pump £75 million ($120.2 million) into translational science, with the aim of transforming biological understanding into clinical impacts that will benefit patients and the UK economy.

Freeze-Drying: Is Technology Advancing Fast Enough?

Experts discuss the best practices for developing a QbD-based lyophilization process.
Apr 2, 2012

Experts discuss the best practices for developing a QbD-based lyophilization process.

Greater International Collaboration

Apr 1, 2012

Medicine regulatory agencies in the EU, US and Australia have been successfully collaborating for some time now with regards to GMP inspections of API manufacturers, but now they are seeking to further expand this international effort by looking to include additional partners.

News

Apr 1, 2012

EMA's electronic pilot; Eli Lilly invests in bio facility

Court Dismisses AstraZeneca's FDA Lawsuit

Mar 29, 2012

A US court has denied AstraZeneca's request for a preliminary injunction against the FDA.

Europe Adopts Transparency Guideline

Mar 28, 2012

The European Medicines Agency has released guidance that outlines a European-wide approach for dealing with transparency and access to information included in marketing authorization applications.

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Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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