EU Court Says Orphan Designation Possible For Same But Better Drugs
The European General Court says that companies are entitled to an independent and new period of orphan market exclusivity for a product that is highly similar to a previously authorized orphan drug.
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A ruling from the EU's top court says the European Medicines Agency was wrong to reject Shire Pharmaceuticals’ application for orphan designation for a new product on the grounds that the active substance it contained already had orphan status. The decision is seen as offering significant opportunities for the R&D-based pharmaceutical industry.
Reports from Norway about deaths in very frail, elderly patients soon after receiving Pfizer/BioNTech’s COVID-19 jab have drawn regulatory scrutiny. While the European Medicines Agency has launched an investigation, Australia is examining the need for specific warnings about risks of vaccination in the very frail elderly or terminally ill patients.
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