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Executive Summary Combination therapies involve the use of two or more separate medicines in combination to treat a disease. It can be...
Cortex - Life Sciences Insights
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On 23 May 2023, Joost Haans from our Life Sciences team attended the EU Pharma Law Forum in Brussels where he participated in the...
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Exactly one month ago, on 26 April 2023, the European Commission (EC) adopted its long-awaited proposal for the revision of the EU...
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On May 3rd of this year, Anvisa approved Resolution No. 786/2023 ("RDC 786/2023"), which addresses the technical and health requirements...
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On the 1 April this year, amidst storm clouds gathering above the NHS in the form of staffing strikes, record waiting times and chronic...
As of March 28, The Italian Council of Ministers have approved the new Public Contracts Code. The Legislative Decree No. 36 of March 31,...
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Companies operating in the life sciences industry play a vital role in raising awareness of diseases and other medical conditions,...
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Due to a complex array of legislation, regulations and codes, advertising therapeutic goods in compliance with Australian law can be a...
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Download a copy of our January monthly briefing, which covers key updates and insights in the following areas: Pharmacies; Clinical...
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The FDA has denied two citizen petitions filed on behalf of the Informed Consent Action Network (ICAN) requesting the agency revoke its...
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We first wrote about the planned amendments to the Pharmaceutical Law and certain other acts (the so-called Verticalisation Act) in...
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The FDA recently published “Sameness Evaluations in an ANDA – Active Ingredients,” a new draft guidance detailing recommendations for...
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When clinical trials for new drug approvals fail to adequately represent racial and ethnic groups, there is a lost opportunity to collect...
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The Inflation Reduction Act (IRA) significantly impacts the US economic model for prescription drug innovation through the imposition of...
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Our EU Life Sciences Regulatory team led by Marco de Morpurgo and Nicola Landolfi have produced a guide on EU Pharma & Medical Device...
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In our latest report, we provide an update on the key legislative changes proposed and introduced in the pharmaceutical sector in Poland.
