Boehringer Files Pradaxa Antidote, Could Lead To Reversible Novel Anticoagulant
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Finishing off a rolling BLA, company believes that the specific antidote for its novel anticoagulant Pradaxa will be eligible for accelerated approval based on Phase I data in volunteers.
You may also be interested in...
Boehringer Avoids Pradaxa Trial, Board Chair Deposition With $650 Mil. Settlement
Settlement expected to resolve approximately 4,000 Pradaxa personal injury claims.
Alvotech Highlights Lack Of Simponi Rivals As It Delivers Golimumab Results
Alvotech has just become the first company to announce positive topline results from a confirmatory clinical study for a proposed golimumab rival to Simponi and Simponi Aria – and moreover, the firm sees limited competition from other biosimilars on the horizon.
Xbrane Assembles The Troops As FDA Says No To Lucentis Biosimilar
Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.