Articles by Stephanie Sutton - BioPharm International

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Articles by Stephanie Sutton

GSK and Daiichi Sankyo Launch Vaccine Venture in Japan

Mar 13, 2012

GlaxoSmithKline (GSK) and Daiichi Sankyo have formed a joint venture that they claim will create the biggest vaccines company in Japan.

Lilly Invests EUR 330 Million in Biopharmaceutical Manufacturing

Mar 6, 2012

Eli Lilly plans to invest EUR 330 million ($443.2 million) at its Kinsale location in Ireland to create a new biopharmaceutical commercialization and manufacturing facility. The investment will lead to 200 new jobs, as well as an additional 300 construction roles during the building process.

South Africa Plans Joint Venture for New API Plant

Feb 21, 2012

The South African government is involved in talks with the Swiss biopharmaceutical company Lonza regarding a joint venture to construct the country's first plant to manufacture APIs for antiretroviral (ARV) medicines.

EMA to Implement Pharmacovigilance

Feb 14, 2012

The European Medicines Agency (EMA) has published an implementation plan for Europe?s new pharmacovigilance legislation, which comes into force in July with the aim of improving the safety and risk?benefit monitoring of drugs.

Pharma Targets Tropical Diseases

Feb 3, 2012

Pfizer, Sanofi, GlaxoSmithKline, and other major pharmaceutical companies have joined forces and pledged to defeat 10 neglected tropical diseases (NTDs) by 2020. The consortium comprises 13 pharmaceutical companies, the United States, United Kingdom and United Arab Emirates governments, the Bill & Melinda Gates Foundation, the World Health Organization (WHO), and several other global health entities.

Global Market Boom for Generic Drugs

Jan 24, 2012

The generic-drugs market is poised to experience strong growth as key blockbuster products go off patent, but companies looking to benefit from this will have to be careful about the product segments where they compete, according to a report from Frost & Sullivan.

BMS to Acquire Inhibitex for $2.5 Billion

Jan 17, 2012

Bristol-Myers Squibb (BMS) has signed an agreement to acquire the clinical-stage biotechnology company Inhibitex in a deal worth approximately $2.5 billion.

FDA Draft Guidance Offers Social Media Insight

Jan 10, 2012

FDA has released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites.

EMA Addresses Ben Venue Quality Issues

Dec 20, 2011

After reviewing the ?shortcomings in quality assurance? that were recently identified at Ben Venue Laboratories?s Bedford, Ohio, facility, EMA issued several recommendations, including product recalls for Ecalta, Liminity and Vistide. EMA?s Committee for Medicinal Products for Human Use has been reviewing medicines manufactured at Ben Venue since early November 2011, after a joint GMP inspection by FDA and the UK and French medicines regulatory agencies highlighted several problems in the company?s quality-management system, particularly in relation to the sterile filling process and possible particle contamination during manufacturing.

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