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Digital Health Transformation: The new Brazilian law on digital drugs leaflets
By Bruna Rocha, Juliana Marcondes, Victoria Cristofaro
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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Patent term extensions and infringement proceedings in Australia, and the standing of an exclusive licensee
By Nicholas Tyacke, Alexandra de Zwart, Sarah McKenzie
For pharmaceutical companies, patent term extensions (PTEs) remain a fundamental means of compensating them for the erosion of the terms...
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Innovation, strategy and collaboration aplenty at the LSX World Congress 2022
By Lyndsey Hudson
It was really fantastic to attend the LSX World Congress 2022 in London on 10th and 11th May. So many excellent conversations to be had...
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Telehealth is Brazil: The Bill goes to the Senate and the Federal Court of Medicine regulates the practice of telemedicine
By Bruna Rocha, Juliana Marcondes, Victoria Cristofaro
On April 27th, Bill n° 1998/20 was approved by the Brazilian Chamber of Deputies of Brazil is currently awaiting approval by the Senate....
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What FDA Expects From Medical Device Cybersecurity Efforts
By Jae Kim, Raymond M. Williams
This article was first published in Law360In recent years, the threat of cybersecurity attacks has evolved in the minds of the public and...
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Poland: new medical devices law
By Amelia Prawda, Jolanta Dabrowicz
On 7 April 2022, the Parliament passed the Act of 7 April 2022 on Medical Devices (the "Act"). It was signed by the President on 20...
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Advising the advisor - Tips for navigating the life sciences and regulatory environment: At the Intersection of Science and Law Podcast Series
By Emilio Ragosa
In this episode, DLA Piper managing partner Emilio Ragosa is joined by Kevin Sheridan, Joint Global Head of Healthcare Investment Banking...
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Access by Spanish patients to authorised medicines in Europe
By Andrea Fernandez, Paula Gonzalez de Castejón Llano-Ponte
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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Ukraine conflict: Impact on clinical trials
By Mariana Ricardo, Ana Rita Santos
Both the Clinical Trials Coordination Group (CTCG) and the Portuguese National Authority of Medicines and Health Products (INFARMED) have...
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New rules on the cultivation of medicinal cannabis in Poland
By Amelia Prawda, Jolanta Dabrowicz
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 Spanish authorities designate an independent supervisory body to ensure compliance with the clinical trials Code of Conduct.
By Elisa Lorenzo
After the publication of the Code of conduct regulating the processing of personal data in the field of clinical trials and other...
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MHRA announce new scheme for monitoring good manufacturing and distributions practices in IAG cases
By Taryn Jones, Teresa Hitchcock
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 moral imperative: Balancing innovation, regulation and prescription drug availability
By Jim Greenwood, Geoffrey Levitt
We stand today on the threshold of almost unimaginable progress in defeating diseases that have ravaged humans for millennia. New...
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The importance behind the recent scientific advances in reversing ageing in human egg cells
By Bruna Rocha, Juliana Marcondes, Victoria Cristofaro
Along with the article about the ascension of FemTechs in the healthcare market, produced by the Life Sciences, Healthcare and Cannabis...
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Patent term extensions in Australia – further challenges for pharmaceutical patentees
By Nicholas Tyacke, Alexandra de Zwart, Sarah McKenzie
Patent term extensions (PTEs) in Australia have been a hot topic over the past year.  On Friday, things got a lot hotter for patentees...
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The new regulatory scheme for Software as a Medical Device approved by Anvisa (Brazil)
By Bruna Rocha, Juliana Marcondes, Victoria Cristofaro
This Wednesday (March 23, 2022), the Brazilian Health Regulatory Agency (ANVISA) approved a Collegiate Board Resolution (RDC) which...
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