Home EIPG Newsletter

EIPG Newsletter

EMA’s updates on the business continuity plan and preparation for the Brexit

EMA’s Board meeting in June 2019 still delayed many regulatory activities due to an estimated 20-25% loss of staff after the move to Amsterdam. Transfer of MAs from UK to EU-27 countries is almost completed in preparation to the Brexit, and some additional workload came also from the entry in force of other pieces of European legislation

Trends for the global pharmaceutical market to 2024

Keytruda is expected to replace Humira as the top selling drug by 2024, according to a report from EvaluatePharma. R&D investments should reduce, while 400 new products should exit pipelines, mainly in the immune-oncology and orphan diseases areas

EU Commission report indicates the 100 top breakthrough innovation to 2038

Hundred breakthrough technologies might revolutionise the current model of society in twenty years' time, says a strategical report from the European Commission. Radical innovation should occur also at the social level, and global value networks are expected to become the reference points for prioritisation of activities and communication and decision-making

Italy: The 2019 AFI Symposium

More than 1,300 professionals from the pharmaceutical industry and 100 sponsors attended the annual meeting of the Associazione Farmaceutici Industria. The debate was centred this year on challenges to be addressed to face the new wave of innovation and globalisation in the sector of life sciences

The WHA has approved the resolution on transparency of drug prices

A step forward towards the target of improving transparency on princing of healthcare products and R&D costs, even if the resolution is just a declaration of principle and its adoption remains voluntarily for member states and companies. In the meanwhile, AveXis' product to treat spinal muscular atrophy has been approved at a price of $2,1 million for single treatment, making it the most costly medicinal product on the market

EIPG: Advisory Group for the education of industrial pharmacists, Open consultations and Coming into...

Many new competencies may be relevant for the work of industrial pharmacists up to 2025. EIPG Advisory Group discussed them during the 2019 General Assembly of the association. Updates on open calls for consultation and coming into effect guidelines

EMA opens the early dialogue to the development of anti-infective therapeutics

Companies working at the development of new anti-microbial treatments can now access early dialogue with the EMA's Innovation Task Force in order to optimise and boost availability of new options. A report by the Inter-Agency Coordination Group of the WHO warns about the possible increase of deaths in future years in case of no action

The Exploitation Strategy and Innovation Consultants network (ESIC)

The network include many different competences and aims to provide consultancy to the European Commision and companies - mainly SMEs - on EU projects management, IP protection and opportunities to obtain investments

Hungary: The new EU MDR raises a lot of uncertainty and concerns for manufacturers

Less than a year to the entry into force of the new Medical Device Regulation, on 26 May 2020, and still many points are waiting for clarification. We provide a summery of the current situation to help preparing the transition to new rules

Biosimilars: the strategic imperative to balance between the needs for innovation and a sustainable...

Biosimilars are not simply generics medicines. The challenge of interchangeability still limits their penetration on the US market, while this issue does not exist in Europe. The development of new biosimilars offers many opportunities for innovation and expansion on the global markets