“Drug repurposing” is finding new therapeutic use of substances no longer protected by patent or regulatory exclusivity. This route is actively pursued by parts of the pharmaceutical industry. But what if there is a high unmet medical need and no commercial interest? This is something that has concerned the European Commission in Brussels. Let us … Continue reading Repurposing as a golden ticket to approval?
Rapid developments in technology have led to the possibility for generation and analysis of vast volumes of data. Will the availability of big data lead to fundamental changes to the regulatory system? The question was addressed by the HMA/EMA task force on Big Data with the aim to “…inform strategic decision-making and planning and to … Continue reading Big data evidence generation drives change in EU regulatory system
Of course they do! The collaboration between EMA and FDA formally started already in 2003. Today the two agencies have almost daily interactions, with the aim to better align, and advance scientific and regulatory excellence worldwide. Already from the start, assessment of oncology‐hematology medicines was discussed. Over the years, groups have been created to cover … Continue reading Do EMA and FDA talk to each other?
Do regulatory agencies approve new medicines earlier and with less data today compared to before? This is a question that has been raised during recent years, but is there some truth in this? The basis for regulatory approval of a new drug is that positive benefit-risk profile has been proven. This decision is based on … Continue reading Drug development create new challenges for regulators
New technology has increased the understanding of disease mechanisms and enabled approval of products targeting small but specific patient populations; sometimes referred to as precision medicine. Gene- and cell therapies have reached the market, exemplified by CAR-T cells, and the research pipeline is promising. In addition, the medical device field is constantly growing creating new … Continue reading Can regulators keep up with innovation?
More than 3 years have passed after the vote and there is still uncertainty around the outcome. At this date, however, the UK prime minister has stated very clearly that he will deliver Brexit the last of October. The discussion of the potential consequences for the Life Science business started soon after the vote. Great … Continue reading Brexit looking back and looking forward