On 6 January 2021, The European Commission has closed the Public Consultation for the inception impact assessment on the revision of the Orphan and Paediatric Regulation. The aim of this initiative was to explore the need for adequate measures to overcome the lack of medicines in the paediatric field. TEDDY Network participated in the EC Consultation
In December 2020 both Pfizer- BioNTech’s and Moderna’s COVID-19 vaccines were approved by the Food and Drugs Administration (FDA), while the Pfizer Vaccine was approved by the European Medicines Agency (EMA) in December 2020 and Moderna’s vaccine in January 2021. In particular, the Pfizer-BioNTech COVID-19 vaccine has been authorized for emergency use by FDA under
We are happy to announce that even this year and with an ongoing pandemic, the youths of KIDS Bari have kicked off their activities[ML1] ! On November 27, KIDS BARI went back to work to promote the involvement of young persons and patients in the research and clinical fields to favour the achievement of goals
The European Joint Programme on Rare Diseases (EJP RD) has launched the EJP RD Joint Transnational Call (JTC) 2021 and will fund multilateral research projects on rare diseases under the EJP-COFUND action. EJP RD has successfully implemented two Joint Transnational Calls since 2019 to further help in coordinating the research efforts of European, Associated and
During the COVID-19 pandemic, the European Medicines Agency (EMA) is implementing exceptional measures to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19 that are approved or are under evaluation. EMA is achieving this by shortening its standard publishing timeframes and publishing information it does not normally publish for other medicines.
The European Medicines Agency (EMA) organized a forum on 15 December 2020 to address the following objectives: - inform on implementation of the HMA-EMA Big Data Task Force; priority recommendations; - understand stakeholders’ perspectives; - discuss opportunities for stakeholder collaboration and priorities. The EU big data stakeholder forum will be held as virtual meeting. It
“The Innovative Medicines Initiative is making a difference to children living with paediatric diseases. Children represent 20% of the EU population and yet many of them live with significant unmet medical need. Less than half of all medicines used by children today are approved for paediatric use. And, for many therapies, there is little or
Ivacaftor (Kalydeco, Vertex Pharmaceuticals) is already FDA approved to treat cystic fibrosis in patients aged 6 months and older. The new approval was based on data from ARRIVAL, a phase 3, open-label, safety cohort study of six children with cystic fibrosis aged 4 months to less than 6 months. All children had at least one
In October 2020 the European Medicines Agency (EMA) expressed positive opinion on the adoption and extension of indication for a number of treatments addressed to the paediatric population. This is the case of Dupixent (dupilumab), for which on 15 October 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted an extension to the
The European Paediatric Formulation Initiative (EuPFI) works to improve the preparation of better and safer medicines for children. One area they are interested in is the “gadgets” or devices (e.g. measuring spoons, dosing cups, inhalers) that are used to help patients take their medicines. It is important that these devices are used properly to make