Sanofi awaits FDA inspection of fill/finish plant before Q1 Kevzara resubmission
Sanofi intends to resubmit its licensing application for Kevzara within the next few weeks following subject to a US FDA re-inspection of a French fill/finish plant.
Archives for February 9, 2017
Workers strike at Merck injectable drug plant in Goa, India over wages
Workers at a Merck KGaA injectable drug and soft gel capsules plant in Goa, India have gone on strike over a wages dispute.
Kitov CEO questioned over Ph III data concerns
Kitov Pharmaceuticals Holdings Ltd. is standing by the validity of its Phase III clinical trial data results as investigations begin.
IntelGenx and Tetra Bio-Pharma developing dronabinol tablet
IntelGenx Corp. and Tetra Bio-Pharma Inc. have signed a binding term sheet for the development and commercialization of a drug product containing dronabinol.
India to allow API firms to request EU quality confirmations online
Indian regulators will allow API firms to seek the confirmations needed to ship to the EU online from next month.
Mouse model program looks to speed drug discovery
Taconic Biosciences has launched a new program to improve access to its cryopreserved mouse models.