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Regulatory

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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 price developments has finally come to a tangible enforcement result: a fine of almost EUR 20 million imposed on Leadiant, manufacturer of the orphan drug CDCA-Leadiant. This penalty decision follows the announcement by the ACM in 2018, repeated in2020 and 2021, that it would scrutinize over-pricing of medicines. The prices of medicines have long been part of a public debate. In its role of the...
July 21, 2021
6 min read
Worldwide Interpol operation Pangea XIV leads to shutdowns...
Operation Pangea is a yearly recurring operation in which Interpol...
June 24, 2021
2 min read
EU merger control – new guidance brings uncertainty...
Illumina’s acquisition of cancer testing startup, Grail, looks...
April 20, 2021
7 min read
Singapore Gets Vaccinated! Introduction of the Pandemic...
As part of a slew of measures to mitigate the effect...
March 25, 2021
6 min read
Introduction of the Narcotic Drugs Amendment (Medicinal Cannabis) Bill 2021
On the 3rd February 2021, the Narcotic Drugs Amendment (Medicinal Cannabis) Bill 2021 (Bill) was introduced...
March 2, 2021
1 min read
Impact of Brexit on Artificial Intelligence in Healthcare
AI developments in the UK The UK is starting to uncover significant opportunities...
February 5, 2021
5 min read
Post-Transition Brexit: New MHRA Guidelines on Medicines
With a post-transition Brexit looming on the horizon, the Medicines and Healthcare products Regulatory...
September 30, 2020
7 min read
Hungary: New Legal Provisions set out Mandatory Infrastructure for Telemedicine
Until recently the Hungarian legal background of telemedicine was not particularly detailed. For obvious...
September 29, 2020
4 min read
Post-Transition Brexit: New MHRA Guidelines on Medical Devices
With a post-transition Brexit looming on the horizon, the Medicines and Healthcare products Regulatory...
September 21, 2020
4 min read
A vaccine for COVID 19 –risks and liabilities in international perspective
As the development of vaccines against COVID-19 is progressing, the question becomes urgent who will...
September 8, 2020
17 min read
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