For innovator firms, Europe has been about surviving multiple price cuts and government austerity measures. For generics firms, it has become a land of opportunity, where 2011 growth will outpace the overall pharmaceutical market.
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The European Medicines Agency’s, human medicines committee, the CHMP, is this week poised to issue opinions on potential marketing approvals for 17 products.
The European Medicines Agency is expected to decide whether to recommend EU-wide marketing authorization for six orphan-designated medicines that are all already approved in the US.
The European Medicines Agency has started reviewing for potential EU marketing approval six new products, including MaaT Pharma’s microbiota therapeutic for acute-graft-versus-host disease, and AstraZeneca's camizestrant for locally advanced or metastatic breast cancer.
The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.
Testimony during a July 21 ‘expert panel’ could help justify stronger warnings across the class about potential adverse effects on mother and baby. Panelists ranged from clinicians who said depression during pregnancy should be treated, to those who said sadness has been “medicalized."
The European Medicines Agency has started reviewing for potential EU marketing approval six new products, including MaaT Pharma’s microbiota therapeutic for acute-graft-versus-host disease, and AstraZeneca's camizestrant for locally advanced or metastatic breast cancer.
The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.
