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The pharmaceutical and healthcare sector is a prime target for cybercriminals around the world. These cyber-attacks represent significant challenges in the context of data protection and data security. The General Data Protection Regulation (GDPR) imposes strict rules regarding the processing and analysis of personal data. In conventional approaches, data analysts request data from various sources

Multiple factors indicate that big data, artificial intelligence and machine learning will play a crucial role in the evolution of pharmaceutical innovation.The ongoing paradigm shift is fuelled by rapid technical advances that have greatly transformed and enhanced many facets of the pharmaceutical sector. Huge datasets are driving new drug discoveries and are making clinical trials more efficient

This is a review of the recent publication “Pharmaceutical Innovation, Competition and Patent Law – A Trilateral Perspective”, edited by Max Planck Director Josef Drexl and Finnish scholar Nari Lee (Edward Elgar 2013, 322 p., ISBN 978 0 85793 245 7). In summary, I conclude that the editors, who also contributed with excellent papers, have succeeded very well in the difficult task of structuring, s

While greater incentives and new funding models for antibiotic drug develooment are needed, it is unclear whether a system dependent on endlessly churning out new and ever more expensive medicines will be economically feasible and scientifically possible in the long term. Greater priority should therefore be given to implementing more permanent solutions that are not limited to slowing resistance,

The novel coronavirus (COVID-19) is challenging the world. With no vaccine and limited medical capacity to treat the disease, nonpharmaceutical interventions (NPI) are the main strategy to contain the pandemic. Unprecedented global travel restrictions and stay-at-home orders are causing the most severe disruption of the global economy since World War II. With international travel bans affecting ov

To update the European League Against Rheumatism (EULAR) recommendations for vaccination in adult patients with autoimmune inflammatory rheumatic diseases (AIIRD) published in 2011. Four systematic literature reviews were performed regarding the incidence/prevalence of vaccine-preventable infections among patients with AIIRD; efficacy, immunogenicity and safety of vaccines; effect of anti-rheumati

By Timo Minssen (CeBIL, UCPH), Sara Gerke & Carmel Shachar A recent US lawsuit highlights crucial challenges at the interface of data utility, patient privacy & data misuse The huge prospects of artificial intelligence and machine learning (ML), as well as the increasing trend toward public-private partnerships in biomedical innovation, stress the importance of an effective governance and

On the sixth year anniversary of Mayo (https://www.supremecourt.gov/opinions/11pdf/10-1150.pdf), our empirical study examines the impact of the US Supreme Court decision on patent subject-matter eligibility, patent examination and patent prosecution of biotech related patent applications before the USPTO. To answer our research questions, we developed an empirical methodology designed to elucidate

Importance: Although highly effective disease-modifying therapies for multiple sclerosis (MS) have been associated with an increased risk of infections vs injectable therapies interferon beta and glatiramer acetate (GA), the magnitude of potential risk increase is not well established in real-world populations. Even less is known about infection risk associated with rituximab, which is extensively

In October 2017, the EU Commission announced a consultation on supplementary protection certificates (SPCs) and research exemptions, including Bolar-type provisions. The consultation will provide valuable input for the Commission when preparing an evaluation of the current EU legislation, and any future policy proposals on SPCs and patent exemptions, including the assessment of the impact of diffe