2020 Sees Sharp Rise In EU New Drug Approvals
Products Include COVID-19 Vaccine & Remdesivir, Plus Three Gene Therapies
Executive Summary
The number of new drugs containing new active substances approved in the EU rose significantly in 2020, underpinned by a strong showing for orphan-designated products and a string of novel medicines for cancer and infectious diseases. Notable among the new clutch of approvals was the first ever COVID-19 vaccine, Pfizer/BioNTech's Comirnaty.
You may also be interested in...
US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development
Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.
Roche Wants EU Pharma Legislative Revision To ‘Dare Something New’
New, more flexible regulatory approaches will be needed to deal with the integrated therapies coming through company pipelines, and the European Medicines Agency should play a “key orchestrating role” in smoothing the way, says Sabine Atzor, Roche’s head of EU regulatory policies.
Results Imminent From Sweden’s Pilot Of Novel Antibiotic Reimbursement Model
If successful, a new Swedish model for reimbursing antibiotics that involves guaranteed minimum annual revenues for companies, could be tested on other kinds of products.