Remove Biosimilars Remove Drug Research Remove Packaging
article thumbnail

Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

Another legislative area that will also likely receive more attention will be the pharma reform package , since the two Parliament rapporteurs to lead the package negotiations were recently appointed.

article thumbnail

Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?

Agency IQ

Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. Reduced market exclusivity would foster generic and biosimilar competition through earlier market access.