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Maureen Kenny
Executive Editor

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Latest From Maureen Kenny
Rejection Rate Soars In Q4 For EU Fast-Track Requests
October and November 2020 were bad months for companies seeking to have their planned EU filings fast-tracked through the centralized drug review system at the European Medicines Agency.
EU Accelerated Assessment Tracker
Bayer has failed to convince the European Medicines Agency that its marketing authorization application for finerenone should be fast-tracked through the EU's centralized review process. There were other successes, though, although Janssen is keeping us guessing over its MAA for amivantamab. These and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.
Plenty Of Action On EU Accelerated Assessment Front
A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.
Argentina Follows UK In Backing Oxford/AstraZeneca COVID-19 Vaccine
While the US and EU regulators seem less than keen on the data package offered to date on COVID-19 Vaccine AstraZeneca, Latin American countries are moving quickly to follow the UK in backing the cost-effective and more-easily deliverable option.
After UK OK, Argentina Backs AstraZeneca/Oxford COVID-19 Vaccine
While the US and EU regulators seem less than keen on the data package offered to date on COVID-19 Vaccine AstraZeneca, Latin American countries are moving quickly to follow the UK in backing the cost-effective option.
Pharma Breathes Sigh Of Relief Over Post-Brexit Trade Deal
The devil will be in the detail but the UK/EU industry's first reaction to the last-minute post-Brexit trade deal is one of relief.