News dal mondo

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Innovation & Pharma: The Molecules & Companies

How truly innovative is the bio/pharma industry? What products, modalities, and companies are behind that innovation? Looking at “first-in-class” new drug approvals, defined as drugs with new mechanisms of action over existing drugs, reveals an interesting picture....[DCAT]

18

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EU Biotech ACT - Ue in ritardo sui farmaci biotech, sempre più ampio il gap con USA

È quanto emerso in un incontro svolto nei giorni scorsi a Bruxelles tra alcuni parlamentari europei...

18

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US FDA Launches Pilot To Expedite INDs

FDA has launched a pilot program to expedite review of investigational new drug (IND) filings with applications...

21

Ago

EDQM - Update to the guidance for electronic submissions of CEP applications

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has updated the guidance PA/PH/CEP...