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The European Medicines Agency is launching a 12-month pilot program to improve the usefulness of postmarket safety data by providing drugmakers with targeted advice on postmarket study design. Read More
The FDA zapped three more compounders over sterility issues, with two Tennessee firms receiving Form 483s and a California facility getting hit with a warning letter. Read More
Pfizer has terminated its over-the-counter Lipitor program in the U.S. after a Phase 3 clinical trial showed that patients required a physician’s help to take the cholesterol-lowering drug correctly. Read More
The International Conference on Harmonisation is recommending that drugmakers limit their use of the solvent methylisobutylketone in drug products after two studies showed toxicity in rats and mice. Read More
The second phase of ISPE’s quality metrics pilot program — which kicked off this month — will continue as planned, despite differences in its metrics and the quality data the FDA plans to collect, says the co-chair of ISPE’s quality metrics team. Read More
Drugmakers in Australia are urging the Therapeutic Goods Administration to raise the number of patients required for classifying an orphan disease, saying it would bring the threshold in line with the EU, Canada and Switzerland. Read More
The European Commission is suspending sales and distribution of 700 formulations of more than four dozen generic drugs after determining that the bioequivalence testing on which their approvals were based included manipulated echocardiogram data. Read More
Teva will pay $40.5 billion to acquire drugmaker Allergan’s generic division. Allergan will retain 50 percent of Teva’s future earnings for its generic Revlimid (lenalidomide) and will retain its biosimilar development programs. Drug Industry Daily erroneously reported Tuesday that Teva was purchasing the entire company. Read More