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The European Medicines Agency is recommending halting sales of 136 drugs whose approval came from flawed bioequivalence studies performed at the Semler Research Centre in India. Read More
The FDA has approved a new drug co-developed by Valeant Pharmaceuticals and Progenics Pharmaceuticals that treats opioid-induced constipation in adults. Read More
Sandoz’s application to produce a biosimilar of Amgen’s bone marrow drug Neulasta has been rebuffed by the agency, according to Sandoz’s parent company, Novartis. Read More
When given the opportunity to use real-world data and adaptive trial designs to secure marketing authorization, drug sponsors often struggle to develop innovative approaches. Read More