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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. Read More
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 regulatory compliance expert. Read More
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 compounding. Read More
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. Read More
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 liver disease called Alagille syndrome. Read More