Companies submitting or holding drug applications who plan to implement a chemistry, manufacturing, and controls (CMC) postapproval change may gain faster agency reviews using a comparability protocol (CP), according to…
Eksa Mills has stopped drug manufacturing activities at its Puebla, Mexico, facility in the wake of an FDA warning letter that cites the company’s quality unit for failure to properly…
AstraZeneca is teaming up with DNA sequencing giant Illumina to seek out potential new drug targets using Illumina’s genomic analysis artificial intelligence (AI) technology. Source: Drug Industry Daily
The FDA has settled litigation by the Outsourcing Facilities Association (OFA) accusing the agency of unlawfully delaying the inclusion of new bulk substances on its approved list of ingredients for…
Nimbus Therapeutics could snag up to $469 million for developing a line of novel metabolic disorder therapeutics for Eli Lilly. Source: Drug Industry Daily
COVID-19 exposed supply chain problems that should have pharmaceutical manufacturers rethinking their standard procedures — from sourcing manufacturing materials to getting completed product safely into customer hands, — says one…
Boston, Mass-based Albireo Pharma said it has hit a phase 3 bull’s eye with Bylvay, an ileal bile acid transport inhibitor under investigation for the treatment of a rare pediatric…
To achieve more diverse clinical trial participation, trial sponsors and sites should be offered incentives and rewards for recruiting more participants from underrepresented groups, according to a pair of researchers…
Baxter Healthcare’s drug manufacturing facility in Marion, N.C., was hit with a seven-observation Form 483 citing inadequate change controls and other quality lapses following an inspection in May. Source: Drug…
The European Medicines Agency (EMA) has set forth quality criteria for data used by EU regulators to support benefit-risk decisions. Source: Drug Industry Daily