As the European Commission prepares for a major revamp to drug legislation, pharma executives and thought leaders worry that even with the new laws, rolling out new drugs to all 27 member states in a short timeframe will be a difficult task to achieve. The proposed law would offer pharma companies an additional years of data protection if new drugs reach all EU markets within 2-3 years of launch, which will be complicated if reimbursement decisions must be made in that period.
Many of the health technology assessment agencies (HTAs) of EU member nations have evidence requirements for cancer drugs that are different than those of the European Medicines Agency (EMA). This disparity often delays patient access. In a new article in Value in Health, authors break down these different requirements to highlight the need for alignment between EMA and EU HTA requirements.
Officials from the European Medicines Agency (EMA) and member state national health technology assessment (HTA) agencies recently announced they were going forward with plans to improve the quality of real-world data (RWD) resources for use in regulatory decision-making. The EMA and HTA bodies established a Big Data Steering Group, which has already endorsed documents that will go through a phase of public consultation.
Pfizer has reported promising results from an EU late-stage trial supporting the use of its 20-valent pneumococcal vaccine in infants. The results will be used in Pfizer’s filing of the vaccine with the European Medicines Agency, which is expected to be completed by the end of 2022. This news comes just over a month after the company reported results from a similar trial in the US.
The EU Commission has approved the Novavax COVID-19 vaccine booster for adults 18 and above. The move comes only weeks after the European Medicine Agency (EMA) recommended the use of booster doses of the protein-based vaccine. The shot is currently authorized for the purpose in 3 APAC countries, Japan, New Zealand, and Japan.
The European Medicines Agency (EMA) has just issued conditional marketing authorization (CMA) for both Pfizer and BioNTech’s bivalent COVID-19 vaccines. The agency’s Committee for Medicinal Products for Human Use (CHMP) approved the vaccines as boosters for people 12 and up. These vaccines contain spike protein mRNA for the original SARS-CoV-2 virus and the BA.4/BA.5 Omicron strains currently dominant across the globe.
The drugmaker Abbvie has applied to the European Medicines Agency (EMA) for marketing authorization for Atogepant, its prophylactic migrain treatment. Data supporting the application comes from two phase three studies, which showed the drug was well tolerated and was effective at reducing the occurrence of migraines.