Newron's CMO, said, "The CHMP
decision on safinamide is a great result for PD patients and physicians, providing them with a therapeutic alternative that is an improvement over "standard of care" in patients with mid-late stage Parkinson's disease patients on L-dopa, who constitute a major proportion (over 75%) of those that are experiencing this progressive debilitating disease.
The H5N1 vaccine was found to be safe and well-tolerated and induced a solid immune response exceeding the three CHMP
(Committee for Medicinal Products for Human Use) immunogenicity criteria for licensure of influenza vaccines.
also expects the marketing authorisation holder for Pandemrix, GSK, to take into account the hypothesis generated by the Finnish research in their experimental research programme into the root cause for the association between Pandemrix and narcolepsy.
The progression of AMT's lead product, Glybera(R) through the assessment process was the key focus of the Group's activities during 2011 until the outcome of the reexamination process of the CHMP
has now initiated at the request of the European Commission a review under Article 20 of Regulation (EC) No 726/2004 to determine whether in light of this quality defect the benefits of Vimpat 15mg/ml syrup continue to outweigh its risks and whether the marketing authorisation for this formulation should be maintained, varied, suspended or withdrawn across the EU.
We are pleased to have achieved this important corporate milestone and are delighted that the CHMP
has agreed to an accelerated assessment," said Dr.
It has also been recalled from the market in Canada, CHMP
s recommendation is based primarily on results of the pivotal Phase III coBRIM study.
opinion was granted following review of the results from a comprehensive clinical program that began in 2007 and included seven trials that evaluated more than 15,000 individuals in more than 11 countries.
based its opinion on clinical data from three multi-national clinical studies involving 195 patients.
positive opinion for Tarceva is an important step in bringing a personalised medicine option to people with lung cancer.
The positive opinion by the CHMP
was announced in response to the Marketing Authorization Application submitted by Eisai in March 2005 for an approval of Inovelon(R) for adjunctive therapy of LGS through the European Union's Centralized Procedure.