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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