Articles by Stephanie Sutton - BioPharm International

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Articles by Stephanie Sutton

EMA Aims to Facilitate Biosimilars Development

Oct 1, 2012

The European Medicines Agency has updated its guidance on biosimilar medicines, with the aim of helping companies to avoid unnecessary repetition of clinical trials.

EMA Streamlines Working Parties

Sep 25, 2012

The European Medicines Agency (EMA) has abolished its Cell-based Product Working Party (CPWP) and Gene Therapy Working Party (GTWP), with the aim of improving efficiencies and optimising the use of available expertise.

J&J to Establish Innovation Centers

Sep 19, 2012

Johnson & Johnson has announced plans to open four innovation centers in California, Boston, London and China, with the aim of accelerating early innovation and facilitating collaboration and investment opportunities.

Potential European Pharmacovigilance Fees Criticized

Sep 18, 2012

The European Generic Medicines Association (EGA) has raised concerns about the potential fees to be charged by the European Medicines Agency for pharmacovigilance activities

Eli Lilly Receives FDA Warning Letter

Sep 10, 2012

Eli Lilly has received an FDA Warning Letter because of a "misleading" image of a multicoloured brain that appeared on the company’s website for the diagnostic PET tracer, Amyvid.

Merck KGaA to Reduce 10% of its German Workforce

Sep 5, 2012

Merck KGaA has announced plans to eliminate 1100 jobs in Germany by the end of 2015—almost 10% of the company's 10,900 German positions.

EMA Seeks to Identify R&D Gaps in Pediatrics

Sep 3, 2012

The European Medicines Agency has launched a public consultation concerning its inventory of paediatric medicines with the aim of highlighting where further R&D efforts are required. The consultation is the first of its kind in this area.

EMA Deals with Manufacturing Deficiencies for Cancer Medicine

Aug 29, 2012

The European Medicines Agency has recommended that the anticancer medicine DepoCyte be recalled from EU countries following the discovery of manufacturing deficiencies at Pacira Pharmaceuticals' San Diego site.

GlaxoSmithKline Divests Brands in Australia for $271 Million

Aug 22, 2012

GlaxoSmithKline (GSK) is selling the majority of its 'classic brands' in Australia to Aspen Global for approximately £172 million ($271.1 million) in cash.

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