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Drugmakers will have to provide more benefit-risk information in common technical documents submitted to the FDA, European Medicines Agency and other regulators, under revised guidance from the International Conference on Harmonisation. Read More
The FDA’s Office of Prescription Drug Promotion warned a Valeant Pharmaceuticals subsidiary for failing to include risk information in promotional material for a cough suppressant. Read More
The Department of Justice is looking into Allergan’s pricing of certain generic drugs as part of a larger federal probe into rising generic prices. Read More
Amarin Pharmaceuticals has a constitutional right to promote its cholesterol-lowering drug Vascepa for an off-label use as long as the communication is truthful and not misleading, a New York federal judge ruled Friday — dealing a blow to FDA efforts to prevent off-label drug promotion. Read More
AstraZeneca is planning to test at least one A2A receptor-blocking compound across a range of cancers, including in combination with the company’s existing immunotherapy portfolio, under a new collaboration with Heptares Therapeutics. Read More
The Indian government has canceled talks with the EU’s chief trade negotiator to protest the European Commission’s ban of scores of generic drugs tested by Hyderabad-based GVK Biosciences. Read More