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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
Drugmakers in the EU have less than eight months to conduct risk assessments of all the excipients they use, under good manufacturing practices guidelines imposed by the European Commission. Read More
Particulates have forced Teva to voluntarily recall lots of its anticancer therapy Adrucil for the second time since May, after silicone rubber pieces from a filler diaphragm and fluorouracil crystals were found in six lots of the product, totaling over 30,000 vials. Read More
Indian active pharmaceutical ingredient maker Mahendra Chemicals was hit with an FDA warning letter for cGMP deviations including data integrity issues — the latest in a crackdown on foreign API makers. Read More
Drugmakers doing business in India should prepare for price caps on more drugs as the National Pharmaceutical Pricing Authority rushes to complete price fixes on 98 essential drugs. Read More
Hikma Pharmaceuticals is purchasing Boehringer Ingelheim’s Roxane generics unit for $2.65 billion, in a deal that will make the Jordanian drugmaker the sixth largest provider of generics by revenue in the U.S. Read More
The FDA has identified 10 quality data points that finished dosage form and active pharmaceutical ingredient makers will need to collect to calculate four quality metrics for each product they produce. Read More