The EMA is proposing to update its two previous guidelines on COVID-19 vaccines to offer consolidated advice on the non-clinical and clinical development of new SARS-CoV-2 or related sarbecovirus vaccines.
The European Medicines Agency is inviting stakeholder feedback on a proposal to update and consolidate its two guidelines on regulatory requirements for COVID-19 vaccines, taking into account new scientific knowledge and lessons learnt from the coronavirus pandemic.
The EMA said changes were needed as the “vaccine development landscape is now very different to that applicable
Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.
EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.
During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.
