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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
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 approval makes Keytruda the first anti-PD-1 treatment option as a first-line treatment for metastatic or unresectable recurrent head and neck cancer. Read More
The board found that Pfenex had a “reasonable likelihood” of proving that its cited prior art would have rendered two of the challenged claims unpatentable. 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