Tag Archives: EMA
By Guest Blogger | Published: April 14, 2014
By Peter O’ Donnell. The European Medicines Agency is determined to minimize opposition to its next moves on releasing clinical trial data. It announced last week yet another consultation on its plans to publish the results of trials — a policy it initially aimed at introducing from the beginning of this year. The latest twist […]
By Pharm Exec | Published: April 3, 2014
The European Parliament yesterday voted towards the adoption of the new Clinical Trials Regulation, which removes the legal framework for pharma to not publish its data by stating that information from trial study reports should not be considered commercially confidential.
By Guest Blogger | Published: March 25, 2014
By Peter O’ Donnell. So at last it’s happened. Adaptive licensing has leapt from the pages of learned journals into the real world of European regulation. Is this the beginning of the end of binary decision-making on the merits of a new medicine? Has a half-century of the “yes/no” authorization process peaked, to be replaced […]
By Pharm Exec | Published: March 21, 2014
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Sylvant (siltuximab) for adult patients with multicentric Castleman’s disease.
By Pharm Exec | Published: February 21, 2014
Europe’s leading pharma industry bodies — EFPIA, EGA, EuropaBio, AESGP and EUCOPE — have issued a joint statement to express concern about “the increasing financial burden of regulatory costs incurred since the adoption of the pharmacovigilance package in 2010″. Procedural fees such as for pharmacovigilance referrals, they argue, have been significantly increased in the last […]