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Regulation & Policy
EMEA receives 24th report of PML case linked with Tysabri
Monday 26 October 2009
There has been a recent surge in new confirmed cases of progressive multifocal leukoencephalopathy (PML) associated with the multiple sclerosis drug, Tysabri (natalizumab), with the 24th case reported to the EMEA on 25 October.
Location
United Kingdom
EMEA recommends approvals for two medicines
Monday 26 October 2009
The European Medicines Agency is recommending that two new medicines, one of which is a radiopharmaceutical, be granted marketing authorisations. It has also given the go-ahead for new indications for four currently licensed treatments.
Location
United Kingdom
EMEA conducts review of Tysabri
Sunday 25 October 2009
The European Medicines Agency has announced a review of the multiple sclerosis drug, Tysabri (natalizumab), in light of reports of 23 cases where patients taking the drug have developed a rare brain infection known as progressive multifocal leukoencaphalopathy (PML).
Location
United Kingdom
Four new drugs get positive EMEA opinions
Monday 28 September 2009
The European Medicines Agency is recommending that four new drugs be allowed onto the market in Europe including a new therapy from Sanofi-Aventis for the treatment of atrial fibrillation.
Location
United Kingdom
Novartis and GSK vaccines for swine flu get go ahead from EMEA
Friday 25 September 2009
The European Medicines Agency has recommended that two vaccines for influenza A (H1N1), known as swine flu, be granted a European Union-wide marketing authorisation. The vaccines are Focetria from Novartis and Pandemrix from GlaxoSmithKline.
Location
United Kingdom
Brussels seeks proposals for €156.3 million of research projects
Tuesday 22 September 2009
The European Commission’s research partnership with industry aimed at finding new ways of making drug development more efficient is preparing to launch a new series of projects valued at €156.3 million
Location
Belgium
EMEA’s Lönngren warns of differences in drug advice
Thursday 10 September 2009
Regulators who strive to ensure the safety of medicines sometimes give different advice to companies developing drugs than do health technology assessment (HTA) bodies that rule on the cost effectiveness of the same drugs.
Location
United Kingdom
Geron submits further data while the FDA puts embryonic stem cell trial on hold
Tuesday 25 August 2009
Geron Corporation of Menlo Park, California, has submitted further animal data to the US Food and Drug Administration on its first-in-man study of a stem cell treatment for spinal cord injury and the agency has put a clinical hold on the study.
Location
United States
Applications for new medicines rise at the EMEA
Tuesday 25 August 2009
The European Medicines Agency gave a record number of positive opinions for new medicines in 2008. However the number of applications that were rejected by the agency, or withdrawn by the applicant, also increased significantly, according to the EMEA’s 2008 annual report.
Location
United Kingdom
EMEA gives positive opinions for five new medicines
Friday 24 July 2009
The European Medicines Agency has given positive opinions for five new medicines, including a biologic from Novartis to treat a rare auto-inflammatory disease and a new indication for Roche’s MabThera for relapsed chronic lymphocytic leukaemia.
Location
United Kingdom
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