Category Archives: Europe
By Guest Blogger | Published: September 24, 2014
What can be gleaned about the direction that health policy will take for the next five years under the new European Commission, scheduled to take office at the beginning of November? Peter O’ Donnell address this question in his new Applied Clinical Trials column here.
By Jill Wechsler | Published: September 24, 2014
Although biopharmaceutical companies and regulatory authorities have made considerable progress in establishing policies for bringing biosimilars to market, key differences and gaps in requirements for testing and documenting product similarity still characterize the European Union, the U.S. and other regions. The EU’s European Medicines Agency (EMA) has set the regulatory pace, with 18 products approved since 2006, […]
By Guest Blogger | Published: September 18, 2014
By Leela Barham. A second payment has now been made under the UK’s Pharmaceutical Price Regulation Scheme (PPRS). Adding a further £76m to the £74m for the first quarter of 2014, the payments received by the Department of Health (DH) now total £150m (US$244m). Payments are a new feature of the long-standing voluntary PPRS. The […]
By Guest Blogger | Published: September 17, 2014
Pharmacovigilance controls are becoming firmly embedded in the European Union’s post-authorization regulatory system, with the European Medicines Agency (EMA) acting as the pivot for an EU-wide network of agencies monitoring medicines throughout their market lifespan. The new pharmacovigilance activities stemming from the EU legislation, the first stage of which was approved four years ago, relate […]
By Pharm Exec | Published: September 16, 2014
Merck’s Keytruda, recently approved in the US to treat patients with advanced melanoma that have stopped responding to other cancer therapies, will soon face strong competition from Bristol-Myers Squibb’s (BMS) Opdivo, an analyst from research and consulting firm GlobalData has reported.