On 1 July 2021, the early access and compassionate use reform entered into force. A medical treatment...
November 10, 2021
6 min read
Pharmaceuticals
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Renewal of early access and compassionate use frameworks in France
Healthcare research and the GDPR – which legal basis is appropriate?
Establishing the correct legal basis under the GDPR is essential for any project involving use of...
October 4, 2021
13 min read
Dutch competition authority ACM imposes EUR 20 million fine on orphan drug manufacturer Leadiant for excessive pricing
The Netherlands Authority for the Consumer and Markets’ ("ACM") announced focus on drug...
July 21, 2021
6 min read
Worldwide Interpol operation Pangea XIV leads to shutdowns and arrests
Operation Pangea is a yearly recurring operation in which Interpol aims to remove the online sale of...
June 24, 2021
2 min read
Spanish courts say “no” to the evergreening on data exclusivity of medicines.
Three recent judgments handed down by the Central Administrative Courts Nos. 4, 10 and 2 on 30 March,...
June 14, 2021
8 min read
First medicinal cannabis drug listed on the Australian Pharmaceuticals Benefits Scheme
On 1 May 2021 Epidyolex, the first medicinal cannabis drug product was listed on the Pharmaceutical Benefits...
May 6, 2021
1 min read
Singapore Gets Vaccinated! Introduction of the Pandemic Special Access Route (PSAR) for COVID-19 vaccines, therapeutic products and medical devices
As part of a slew of measures to mitigate the effect of the COVID-19 pandemic in Singapore,...
March 25, 2021
6 min read
Chinese patent linkage system – the Chinese Supreme Court issues Draft Judicial Interpretations
The Chinese Supreme Court (“SPC”) released on 29 October 2020 the “Provisions on Several...
November 13, 2020
6 min read
Australian Courts apply “European Support” test to find key Wyeth’s Prevnar 13 patent invalid
In the recent decision in the Australian front of the Prevnar 13 patent litigation, Merck...
November 4, 2020
10 min read
AstraZeneca held liable for additional healthcare costs
In a judgment of 14 October 2020 the District Court The Hague ruled in a landslide decision that AstraZeneca...
October 15, 2020
10 min read