28 results found

A new application process and accompanying guidance will hopefully make it easier to get started with such studies.

The European Medicines Agency (EMA) has published a revised version of its User Guide for micro, small and medium-sized enterprises (SMEs) in the pharmaceutical sector.

Kromann Reumert has assisted the Joint Global Coordinators and Joint Bookrunners and the Lead Manager in connection with the directed issue and private placement of 8,350,000 new ordinary shares...

In collaboration with Amgros and Lif, the Danish Medicines Council has prepared a new guideline describing how alternative contract models can be included in applications to the Danish Medicines Council.

The Ministry of the Interior and Health of Denmark as well as the Danish Regions and the Danish Association of the Pharmaceutical Industry (LIF) have all agreed to extend the existing price cap agreements...

Just before Christmas, following debate in the Danish media on the Industry's use of HCPs as consultants, the Danish Industry Board, ENLI, clarified the rules on the Industry's use of HCPs as consultants.

Pharmaceutical innovator companies increasingly have to consider the potential prior art effect of clinical studies carried out in order to gain approval of their medicines.

The European Commission has just adopted Implementing Regulation (EU) 2024/1381 laying down procedural rules for common clinical assessments of cancer and ATMP...

The Danish Medicines Agency has updated its practice on the naming of medicines.

New proposals for amendments to the Medicines Act, the health Act and the Committee Act have been presented.

The newly adopted proposal to amend the Medicines Act aims to ensure that selected pharmaceutical companies have safety stockpiles that can meet the need for critical medicines...

As both climate change and increased environmental pressures continue to make traditional cocoa production increasingly unsustainable, confectioners are making even greater efforts...

The new pilot program, applicable from 1 July 2025 to 30 June 2028, allows pharmaceutical companies to apply for reimbursement for prescription-only medicines based on a confidential price.

In 2020, the number of international patent applications filed via WIPO continued to grow amid the COVID-19 pandemic, and currently there is a noticeable renewed interest in vaccine and antibody-related patents.

The ICH has adopted its revised Guideline for Good Clinical Practice (GCP) E6(R3) on 6 January 2025.

While more sustainable products are rightfully at the vanguard of the food and drink industry, the niche that arguably needs to innovate fastest is chocolate. It is not news to report that consumers...

En beskyttet oprindelsesbetegnelse kan tildeles fødevarer, som har oprindelse et bestemt sted og kvaliteten af produktet stammer fra det geografiske miljø.