The first pan-Scandinavian tender for delivery of medicinal products has been completed

In co-operation with its Norwegian counterpart, Amgros has now completed the first pan-Scandinavian tender for the delivery of medicinal products.

Article  -  13.02.2020

The European Court of Justice dismisses general presumption of confidentiality for clinical and toxicological study reports

In the parallel cases C-175/18, PTC v EMA, and C-178/18, MSD v EMA, the European Court of Justice has considered the general question whether there is a general presumption of confidentiality for clinical and toxicological study reports submitted to the European Medicines Agency as part of an application for a marketing authorisation.

Article  -  31.01.2020

Preliminary injunction against the veterinary drug Forceris

By a ruling of 3 January 2020, Bayer has obtained a preliminary injunction from the Maritime and Commercial High Court against the sale, use and possession of Ceva's veterinary drug Forceris. Plesner represented Bayer in the trial.

Highlight  -  24.01.2020

Revision of the ENLI's Codes of Conduct

ENLI has made amendments to its codes of conduct as a consequence of EFPIA's consolidation of its three codices (the EFPIA HCP Code, the EFPIA PO Code and the EFPIA Disclosure Code).

Article  -  18.12.2019

The Danish Regions propose to establish a Treatment Council

The Danish Regions have proposed a new model for establishing a so-called Treatment Council which is to assess whether the price of treatments and health technology measure up to the effect for the patients. The model will now go out for consultation.

Article  -  18.12.2019

New assessment method for medicines and the use of non-published data in the Danish Medicines Council

The Danish Regions have decided that as of October 2020, the Danish Medicines Council is to use the QALY measure for assessment of new medicinal products, and that with immediate effect the Danish Medicines Council will be able to include non-published data in its assessment of the medicines' effect.

Article  -  28.11.2019

The EUDAMED database is delayed by two years

The European Commission has announced that the new pan-European database, EUDAMED, will be delayed by two years.

Article  -  01.11.2019

Novo Holdings, Nordic Capital and Astorg to invest in ERT

The private equity group Astorg invests in eResearch Technology Inc. ("ERT") and will enter as a partner alongside existing owners Novo Holdings A/S, Nordic Capital, and the ERT management team.  Plesner has advised Novo Holdings A/S in relation to the transaction.

Highlight  -  24.10.2019