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UCB receives EU approval for paediatric anti-epileptic drug
UCB has announced that the EC has approved the use of its anti-epileptic drug Vimpatas in the treatment of partial-onset seizures...
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European Medicines Agency (EMA)
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Novartis receives EU approval for ribociclib
Novartis announced that the European Commission approved ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with metastatic breast cancer
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Experimental treatment for Niemann-Pick disease appears safe
An experimental drug has appeared to slow the progression of Niemann-Pick disease type C1...
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Report identifies two-tier pharmaceuticals market
A report released has identified a two-tier manufacturing market and forecast increased acquisitions by Indian companies...
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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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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...
