Manufacturing and Production

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BMS and Sanofi recall 64 million Avalide tablets

January 18, 2011 Manufacturing and Production Avalide, Avapro, Bristol-Myers Squibb, GMP, Good Manufacturing Practice, Sanofi-Aventis, hypertension, irbesartan

Bristol-Myers Squibb and Sanofi-Aventis have started another massive recall of their antihypertensive product Avalide because a manufacturing defect could affect …

Shire says new plant will add to Replagal, Vpriv capacity

January 17, 2011 Manufacturing and Production Cerezyme, Replagal, Shire, Vpriv

UK drugmaker Shire has completed construction of a new manufacturing facility for its orphan disease drugs Replagal and Vpriv, and …

Watermeadow supports charity cycle ride

January 13, 2011 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

 Watermeadow is the proud sponsor of a team of Burford fire fighters and their colleagues who cycled 983 miles from …

Aurobindo sells Chinese API unit to Sinopharm

January 13, 2011 Manufacturing and Production API, Aurobindo Pharma, China, Sinopharm Weiqida Pharmaceutical, active pharmaceutical ingredient

Indian company Aurobindo Pharma intends to sell off a loss-making active pharmaceutical ingredient unit to Sinopharm, the largest pharmaceutical company …

Marketing authorisations for medicines: UK Decentralised Procedure slots available in all therapeutic areas in 2011

January 12, 2011 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

The MHRA has reported it has RMS decentralised procedure slots available in 2011 for all therapeutic areas, including biologicals and …

Regulatory assistance available to Small and Medium-sized Enterprises (SMEs)

January 12, 2011 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

The increasing number of SMEs in Europe is seen to be a driving force to facilitate economic growth, new product …

Deadline approaching for cancelling UK Licences

January 12, 2011 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

The MHRA has recently advised all holders of UK marketing authorisations, registrations and licences to inform them by the 31st …

Updated report on origins of clinical trial participants

January 12, 2011 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

The European Medicines Agency has published an updated report detailing the geographical origins of patients included in clinical trials for …

Scientific Advice and Guidance Available

January 12, 2011 Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing

In April, we reported how a joint pilot scheme operated by the UK Medicines & Healthcare Products Regulatory Agency (MHRA), …

Savient plays down gout drug manufacturing problems

January 11, 2011 Manufacturing and Production, Sales and Marketing Krystexxa, Savient, biologic manufacturing, gout, manufacturing compliance, pegloticase

Savient Pharmaceuticals has reported that some production batches of Krystexxa, its recently-approved second-line treatment for gout, have failed to meet …

Dendreon will outsource first Provenge production in EU

January 11, 2011 Manufacturing and Production Dendreon, Provenge, cancer vaccine, contract manufacturing, sipuleucel-T, vaccine manufacturing, vaccines

US oncology specialist Dendreon has decided to hire a contract manufacturer for its cell-based cancer therapy Provenge in Europe to …

More US recalls as bill seeks greater FDA powers

January 10, 2011 Manufacturing and Production Centocor Ortho Biotech, Cumberland Pharmaceuticals, FDA, RiteDose Corp, Sandoz, Sigma-tau Pharmasource, Teva Pharmaceuticals, manufacturing compliance, recalls

Product recalls continue to make headlines in the pharmaceutical sector, with several new incidents either side of the New Year …
GSK's UK headquarters

GSK hits back at 60 Minutes whistleblower interview

January 6, 2011 Manufacturing and Production 60 Minutes, Avandamet, Bactroban, Cheryl Eckard, GSK, GlaxoSmithKline, Kytril, Paxil, manufacturing compliance

GlaxoSmithKline has responded to an edition of US current affairs show 60 Minutes centring on manufacturing problems at its now-closed …
Novartis Holly Springs

Novartis adds R&D unit to new vaccines plant

December 31, 2010 Manufacturing and Production, Research and Development Novartis, pharma manufacturing, vaccines

Swiss drugmaker Novartis is planning to spend $36 million to set up an R&D laboratory on the site of its …
The Gateway to Local Adoption Series

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