Category Archives: Regulatory

EGA Calls for Removal of Barriers to Generics in Europe

Adrian van den Hoven, Director General of the European Generics Association (EGA), this week called for the removal of barriers to generic medicines across the European Union.
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Biotech Industry Calls for Pan-European Tax Incentives

Europe’s biotech industry body, EuropaBio, has launched a report urging European governments to remain committed to biotech research, development and innovation (RDI) incentives, following release of the European Commission’s (EC) 2014 Innovation Scoreboard.
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Allergy Shots in a Pill?

Allergy season’s dank fecundity might be welcomed in many parts of America this year. Anything that’s warmer. But the worst allergy sufferers might soon be headed back to the doctor’s office for another round of allergy shots. Or perhaps not. ALK-Abelló, a Denmark-based specialty pharmaceuticals company focused solely on allergy immunotherapy products, expects FDA to […]
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FDA, Sponsors Seek Study Endpoints Earlier in Development

As payers demand more evidence documenting medical product value, biopharma companies are responding by moving sooner to decide key clinical outcomes to measure. While clinical trials still have to document product safety, efficacy and quality, sponsors also look to demonstrate suitability for formulary placement and reimbursement. Food and Drug Administration officials support these strategies to […]
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Adaptive Licensing: The Start of a Slow Revolution in Europe

By Peter O’ Donnell. So at last it’s happened. Adaptive licensing has leapt from the pages of learned journals into the real world of European regulation. Is this the beginning of the end of binary decision-making on the merits of a new medicine? Has a half-century of the “yes/no” authorization process peaked, to be replaced […]
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