Anticipating the loss of royalties from Crestor in the next five years, Japanese innovator Shionogi continues its globalization process with a U.K. headquarters to pursue development of its late-stage research pipeline in Europe.
The Japanese pharmaceutical company Shionogi & Co. Ltd. has for the first time established a direct business presence in Europe, by setting up its European headquarters in London. The H.Q. will be involved across Europe in coordinating R&D, although the company has not yet decided whether it will have a commercial presence in each country or will market through partners.
The move is part of a globalization process that started with the acquisition of the U.S. company Sciele Pharma in...
Arimoclomol, Zevra Therapeutics's treatment for Niemann-Pick disease Type C, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
A task force set up by the EMA to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor interaction.
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
