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The FDA has asked for more information on the pen injector device used in Sanofi and Zealand Pharma’s IGlarLixi combination product for diabetes, extending its review by three months. Read More
Almost a year after Bayer settled pay-for-delay allegations involving its antibiotic Cipro, Ireland-based Allergan and France-based Sanofi units have struck deals to resolve lingering Cipro claims in ongoing class action litigation, agreeing to pony up $100 million. Read More
Lima & Pergher Industria failed to provide stability data to ensure its drug products’ expiration dates and did not perform microbiological testing on each finished product, the FDA said in a warning letter to the Brazilian company. Read More
The EMA is trying to simplify data integrity compliance by compiling all of its expectations into a single document that covers the entire data integrity lifecycle. Read More
After the EMA issued a report on its adaptive pathway, a German agency took the agency to task for leaving stakeholders in the dark on real-world evidence use. Read More