EMA Biosimilars Draft: Non-EU Reference Avoids Clinical Trial Repeats
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21-May-2013 - The EMA (European Medicines Agency) has released draft guidelines on biosimilars allowing non-EEA comparators to be used in limited circumstances. Related news |
News in brief
Lonza Not 'Shellfish' When it Comes to Endotoxin QC Testing
21-May-2013 - Lonza says it is raising awareness of the role horseshoe crabs play in QC endotoxin detection tests, and its PyroGene Assay can provide a sustainable alternative.
US House Bill Aims to Expand Release of Clinical Trials Data
21-May-2013 - US House Democrats have re-introduced a bill that would expand trial data reported by companies to clinicaltrials.gov, but a recent EU court decision shows what kind of resistance should be expected.
Russia Working to Align Biologics Regs with International Standards
20-May-2013 - Regulators and the drug industry met in Moscow last week to develop a framework for firms developing biologics and biosimilars in the Russian Federation.
People on the Move: Pharma Jobs
20-May-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Bayer, Valeant and Eisai.
UK Animal Research Labelling Plan Must Not Put Patients Off Treatment, Says ABPI
16-May-2013 - New UK proposals to label all drugs as “produced as a result of research on animals” have met with muted response from the ABPI.
US House Committee Advances Track-and-Trace Legislation
16-May-2013 - The US House Energy & Commerce Committee on Wednesday advanced a bill to further secure the US prescription drug supply chain, though it stops short of mandating unit-level, electronic tracking and tracing of drugs.
Coalition Calls for Science-Based Approach to Elemental Impurity Testing
15-May-2013 - Differences in elemental impurity standards being developed separately by the US Pharmacopeia and ICH could mean costly reformulations according to a pharmaceutical, API and excipient industry coalition.
Regulatory & Safety: Featured news
Gallery
People on the Move: Pharma Jobs
In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Bayer, Valeant and Eisai.
Gallery
People on the Move: Pharma Jobs
In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Mylan, Sigma-Tau and Immunocore.











