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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
Sponsors of new drug applications in China must submit comprehensive data showing adherence to clinical trial requirements by Aug. 25 — in a surprise move that could prompt noncompliant or unprepared companies to withdraw their applications, reducing a pending backlog of more than 1,600. Read More
AstraZeneca is selling its rare cancer drug Caprelsa to Sanofi for up to $300 million, as the company continues to raise cash by divesting assets. Read More
The European Medicines Agency is seeking feedback on draft guidelines on conditional approval and accelerated assessment as it strives to fast track medicines for unmet medical needs. Read More