The European Medicines Agency (EMA) has launched a new pilot programme aimed at supporting the development of highly innovative medical devices with the potential to address unmet medical needs. “Breakthrough designation” may be granted to medical devices...
The processing of personal data for scientific research purposes has given rise to a number of important and sometimes difficult questions from controllers, processors and supervisory authorities. In order to make GDPR compliance easier for researchers and...
The European Commission, through the European Health and Digital Executive Agency (HaDEA), has published an article highlighting projects funded under the EU4Health programme that support the development of orphan medical devices for children living with rare...
The European Medicines Agency (EMA) has opened a public consultation to guide the generation and assessment of meaningful proof-of-concept data for the development of medicinal products in paediatric oncology. The availability of adequate proof-of-concept data is...
The FGB Pills are a new series of short informational videos designed to make complex topics related to health, research, and biomedical innovation more accessible. The FGB Pills aim to provide clear, concise, and evidence-based content, intended for a broad audience:...
The European Medicines Agency launched three new tools to support PRIME, the Agency’s scheme to enhance support for the development of medicines targeting an unmet medical need. These tools are the result of five-year analysis of PRIME and of the completion of...
The European Medicines Agency (EMA) has taken a significant step towards more ethical and innovative medicines development. Its Committee for Medicinal Products for Human Use (CHMP) has issued a draft qualification opinion on a novel methodology in non-clinical...
HemaFAIR, in collaboration with the HELIOS (COST Action) network, has contributed to the public consultation launched by the European Commission on the forthcoming Action Plan for Women in Research, Innovation and Startups, providing input on a key priority for the...
RNA-targeted agents are drugs based on short single or double stranded nucleic acid molecules (known as antisense oligonucleotides) which are designed to bind specific RNA sequences, ultimately altering the expression of targeted genes. They represent an emerging area...
An extraordinary study, the result of research conducted at the Bambino Gesù Children’s Hospital (Italy) in collaboration with the University of Erlangen (Germany), was recently published in Nature Medicine. Eight paediatric patients, suffering from autoimmune...
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