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Personalised medicine, batch size of ONE, the new challenge to fill-finish?
Wenzel Novak PhD gives some considerations on container, environment, process and automation for small batch sizes in the downstream process of fill-finish…
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European Medicines Agency (EMA)
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Amber warning for the UK’s access to new medicines post Brexit
Independent health economist lays out solution for how the UK could handle pharmaceutical regulation after Brexit.
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EMA approves Janssen’s Prezista continuous manufacturing line
The EMA has approved Janssen's continuous manufacturing (CM) with real-time release testing for the production of Prezista (darunavir)...
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EMA issues guidance document in preparation for Brexit
The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies prepare for the United Kingdom's withdrawal from the European Union.
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EMA action plan supports SMEs as drivers of innovation
The European Medicines Agency (EMA) has published an action plan that aims to foster innovation and support small and medium-sized enterprises (SMEs) in the development of novel human and veterinary medicines.
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FDA approves BioMarin’s manufacturing facility in Cork, Ireland
The FDA has approved BioMarin Pharmaceutical’s bulk biologics manufacturing plant, located in Cork, Ireland for production of the formulated bulk substance.
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ViiV Healthcare submits regulatory applications for HIV two-drug regimen
6 June 2017 | By Niamh Marriott, Junior Editor
Regulatory submissions to the EMA and FDA for a single-tablet, two-drug regimen of dolutegravir & rilpivirine for the maintenance treatment of HIV...
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EMA to review Sandoz biosimilars adalimumab and infliximab
Sandoz announced that the EMA has accepted for regulatory review for biosimilars to AbbVie's Humira (adalimumab) and Janssen's Remicade (infliximab)...
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First treatment for 5q spinal muscular atrophy approved by EU
1 June 2017 | By Niamh Marriott, Junior Editor
The EC has granted marketing authorisation for Ionis Pharmaceuticals’ Spinraza (nusinersen) for the treatment of 5q spinal muscular atrophy (SMA)...
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Aptar Pharma’s electronic lockout device approved by EMA
1 June 2017 | By Niamh Marriott, Junior Editor
The European Medicines Agency (EMA) has approved Aptar Pharma’s integrated electronic nasal lockout device (e-Lockout) following a partnership with Takeda.
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New EMA guidelines on biosimilar medicines
1 June 2017 | By Niamh Marriott, Junior Editor
The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines...
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Why biosimilars are changing the pharmaceutical industry
26 May 2017 | By Ho-ung Kim, Head of Strategy and Operations Division for Celltrion Healthcare
We caught up with Celltrion Healthcare's Ho-ung Kim to find out how biosimilars cut costs, increase access to medicine and are ultimately changing the industry…
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Relocating the EMA: An open letter from EFPIA and Pharma Heads of Research
16 May 2017 | By European Federation of Pharmaceutical Industries and Associations (EFPIA)
The EMA is a world class regulator, whose scientific recommendations are a vital element of the ongoing effort to provide EU citizens with quality medicines
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European Medicines Agency’s 2016 annual report published
11 May 2017 | By Niamh Marriott, Junior Editor
EMA's report focuses on key achievements in the areas of medicine evaluation, support to R&D of new and innovative treatments and safety monitoring...
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Ireland reiterates bid to host the European Medicines Agency post-Brexit
9 May 2017 | By Niamh Marriott, Junior Editor
Ireland has stepped up its bid to host the European Medicines Agency (EMA) with the official announcement being delivered and reiterated bySimon Harris...
