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The Pharmaceutical Inspection Co-operation Scheme (PIC/S) released draft advice for GMP inspectors on evaluating risk-based changes to pharmaceutical quality systems (PQSs). Read More
Walgreens and other big name retailers have filed an antitrust suit against Bausch Health, its subsidiaries, and generic drugmaker Lupin for allegedly plotting to hike the price of Bausch’s diabetes drug Glumetza and Lupin’s generic version. Read More
The Senate committee on Health, Education, Labor and Pensions voted 18-5 on Tuesday to advance Stephen Hahn’s nomination as FDA commissioner to the Senate floor. Read More
The FDA has issued a final guidance on adaptive clinical trials, reworking its subsection on Bayesian methods and clarifying the extent of pre-specification required for the rules governing adaptations. Read More
Lexicon Pharmaceuticals has lost its appeal to the FDA of the agency’s complete response letter in March for its investigational add-on type 1 diabetes treatment Zynquista (sotagliflozin). Read More
The FDA’s Division of Pharmaceutical Quality Operations hit repackager Loxha with a warning letter for lacking stability data and other GMP failures. Read More