Topic European Medicines Agency

Genzyme, a Sanofi company, announced that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved a second suite for filling and finishing product at its Waterford, Ireland manufacturing plant.  With this approval, Genzyme has nearly doubled its ability to fill a more

Clinuvel Pharmaceuticals Limited announced that it has submitted a marketing authorisation application (MAA) for its first-in-class drug SCENESSE® (afamelanotide 16mg implant) to the European Medicines Agency (EMA). The MAA covers the use of SCENESSE® as a prophylactic treatment in adult patients wi more

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Signifor® (SOM230, pasireotide) for the treatment of Cushing's disease. There are currently no approved medicines in the European Union (EU) targeting Cushing's disease, a more

As demonstrated here, there are a broad range of HPLC applications used in development, production, validation and release of protein therapeutics for human use. Some of the applications mentioned above are mandatory when submitting a new biopharmaceutical to approval at the regulatory agencies. The introduction of the first so-called biosimilars in Europe further increased the demand for highly efficient analysis methods. The continuous development of new stationary phases for the common modes of biochromatography, such as size exclusion, ion exchange and hydrophilic interaction chromatography support biochemists in increasing lab productivity and establishing high-throughput HPLC analysis not only for small molecules but also for large biopolymers more

Shining a light on trial data Nature Biotechnology 30, 371 (2012). doi:10.1038/nbt.2237 The European Medicines Agency's request to make all clinical trial data available is key to countering bias in publication, drug prescription practice and health policy. more

Summary The human leucocyte antigen (HLA) system is well known for its association with certain diseases such as ankylosing spondylitis, celiac disease and many others. More recently, severe and even fatal drug hypersensitivity reactions linked to particular HLA alleles have been discovered. The more

Summary What is known and Objective:  The lag in the approval and development of psychiatric drugs between Japan and other countries has been a major issue both for patients with psychiatric diseases and for psychiatrists. The objective of this study was to analyse factors contributing to delays more

GBI Research, the leading business intelligence provider, has released its latest research “Endpoints - Clinical Trials in Cardiovascular Disorders - Optimal Use of Surrogate Endpoints and Clinical Biomarkers are Key Determinants of Success” which provides an insight into the different endpoints tha more

How will the stem cells market develop this decade? Our new report shows you that emerging industry and market's revenue potential from 2011 to 2021. This report covers stem cells in therapeutic applications: technologies, products and services. You will assess events, opportunities and activities more

What are the commercial prospects for the pharmacological treatment of acute coronary syndrome? Our new report shows you its revenue potential from 2011 to 2021. We predict and explain the commercial opportunities in that industry and market. Our report gives you revenue forecasts to 2021 for treat more