Australia streamlines AE drug reporting with international E2B standard
This article was originally published in SRA
Australia’s Therapeutic Goods Administration has made it easier for drug companies to submit adverse event (AE) reports on medicines to the agency by giving them the option of using the international E2B standard to electronically transfer safety data1.
You may also be interested in...
While Accord HealthCare has convinced the European Medicines Agency that its rivaroxaban generic should be approved in the EU, Bayer has warned that patent protection for Xarelto continues until at least late 2023. The EMA this week also recommend approval for a number of other new drugs.
Akcea Therapeutics has lowered its asking price in England for its antisense therapy for familial chylomicronaemia syndrome. It has also struck a pricing and reimbursement deal for the drug in Germany.
The sponsors of up to seven new drugs or vaccines will find out this week whether their products will soon be approved in the EU. The products include two vaccines from Sanofi and what is possibly the first generic rival to Bayer's Xarelto to be assessed by the European Medicines Agency.