Europe

EMA investigates Roche's alleged non-compliance with pharmacovigilance obligations

Wednesday, October 24, 2012 09:46 AM

The European Medicines Agency (EMA) has initiated an infringement procedure against Roche Registration, following a request of the European Commission, to investigate allegations that the company has failed to comply with pharmacovigilance obligations in relation to its 19 centrally authorized medicines.

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Novasep invests $39M to build world's largest chromatography plant

Friday, October 12, 2012 01:43 PM

Novasep, a provider of purification-based manufacturing solutions for life science molecules, has invested almost $39 million to build the world's largest chromatography plant used for the production of a large volume commercial active pharmaceutical ingredient (API).

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Recipharm, Astimex form development and manufacturing collaboration

Friday, October 12, 2012 11:58 AM

Recipharm, a Swedish contract development and manufacturing organization, and Astimex Pharma, a Swedish pharmaceutical company, have formed a collaboration agreement for the development and manufacture of a pharmaceutical product.

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Almac concludes commercial API manufacturing facility expansion plans

Wednesday, October 10, 2012 10:14 AM

In response to client requirements, global service provider Almac’s expansion of their API manufacturing facility at its European headquarters in Craigavon, U.K. is near completion, and will be operational by the end of the year. 

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Almac expands U.K. capacity with the acquisition of blistering tech

Wednesday, October 3, 2012 03:24 PM

Almac, a global service provider, has expanded its MHRA/FDA approved U.K. commercial packaging facility with the acquisition of a state-of-the-art Noack N 623 blister packaging line from Romaco.

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Novartis receives E.C. approval for once-daily Seebri Breezhaler for COPD

Monday, October 1, 2012 12:11 PM

The European Commission has approved Novartis’ Seebri Breezhaler (glycopyrronium bromide) 44µg delivered dose, as a once-daily inhaled maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

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Quintiles, Scottish health boards partner to accelerate research

Monday, October 1, 2012 09:41 AM

Quintiles, a fully integrated biopharmaceutical services company, formed a strategic partnership with the four teaching health boards—Aberdeen, Dundee, Edinburgh and Glasgow—in Scotland as part of its Prime Site program to accelerate the development of new and more effective medicines.

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PsiOxus launches phase I/II trial of oncolytic vaccine in metastatic cancer

Wednesday, September 26, 2012 12:07 PM

PsiOxus Therapeutics, a U.K.-based development stage biotech, has treated the first patient in its phase I/II clinical trial of ColoAd1for the treatment of metastatic solid tumors.

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Thermo Fisher opens molecular biology center of excellence in Lithuania

Wednesday, September 26, 2012 11:45 AM

Thermo Fisher Scientific, a global service provider, has officially opened its molecular biology center of excellence in Vilnius, Lithuania. The new facility will provide molecular, protein and cellular biology products to better serve growing demand from life sciences customers throughout Eastern Europe and create new opportunities globally.

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Successful MHRA inspection of Almac’s clinical services U.K. facility

Wednesday, September 26, 2012 11:18 AM

Global service provider Almac passed a successful inspection of its clinical services operations located in Craigavon by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).

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