This week our Life Sciences team published the first edition of its Cross-border Guide to Clinical Trials and Privacy. The Guide will...
Cortex - Life Sciences Insights
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pharmaceuticals
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The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued a joint statement on the interchangeability of...
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After a brief hiatus from the string of Warning Letters sent to 503B outsourcing facilities in mid- to late 2021, on June 7, 2022, FDA...
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The COVID-19 pandemic, followed by the Ukraine war, has led to an economic crisis that has resulted in supply difficulties and a sharp...
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Yesterday morning (12), the Brazilian Federal Government approved Law n. 14,338/22, which results from a bill of the Chamber of Deputies...
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For pharmaceutical companies, patent term extensions (PTEs) remain a fundamental means of compensating them for the erosion of the terms...
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The annual report "Indicators of Access to Innovative Therapies in Europe (W.A.I.T. Indicator)", prepared by the consultancy firm Iqvia...
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Both the Clinical Trials Coordination Group (CTCG) and the Portuguese National Authority of Medicines and Health Products (INFARMED) have...
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On 29 March 2022, the Polish President signed the Act of 24 March 2022 amending the Act on Counteracting Drug Addiction (the "Act"). The...
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The Medicines & Healthcare products Regulatory Agency (MHRA) has announced a new supervisory scheme as part of its process for monitoring...
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The Association of the British Pharmaceutical Industry (ABPI, the UK’s leading association for pharmaceutical companies), has published a...
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In a note published on 2 March 2022, the Italian Medicines Agency (AIFA) confirmed that all pharmaceutical companies must, by no later...
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Having previously examined the impact of implementing international reference pricing in the United States, Charles River Associates (a...
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Accelerating Clinical Trials in the EU (ACT EU) was launched a few days ago, with the aim of transforming the way in which clinical...
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Off-label use of medication is currently not regulated in Romania. Rather, it is up to the doctors to decide on the off-label use of a...
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Ordinance no. 280/2021, dated 3 December (entering into force on December 4, 2021) creates an exceptional criterion to be used in the...