With the proposals for an overhaul of the EU pharmaceutical legislation tentatively scheduled for publication on 29 March, the European industry federation EFPIA claims that the plans as currently drafted will drive investment away and damage the industry’s ability to compete at global scale. But the European Commission insists the revision will boost industry's global competitiveness and innovative power.
The European Commission’s proposals for revising the EU pharmaceutical legislation will be “extremely damaging to the competitiveness of Europe’s industry and to our region’s strategic autonomy,” says Nathalie Moll, director general of the European pharmaceutical industry federation, EFPIA.
Whether the proposed legislation is “naivety, blind optimism or a more conscious decision to rely on innovation from the US...
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
