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Ohio’s attorney general filed a lawsuit against Purdue Pharma, Endo Health Solutions, Teva, Johnson & Johnson and Allergan this week, alleging they contributed to the opioid epidemic through fraudulent advertising. Read More
The European Medicines Agency says marketing authorization holders must be based in the European Economic Area post-Brexit — and UK-based companies will likely need to transfer marketing authorizations to new addressees. Read More
Amgen is suing the FDA, requesting that its Sensipar medication be granted six additional months of pediatric market exclusivity after it completed three of four pediatric clinical trials requested by the agency. Read More
Less than two weeks on the job and FDA Commissioner Scott Gottlieb is getting pressure from Capitol Hill to change official FDA guidance for compounders. Read More
More drugmakers have weighed in on the FDA’s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy. Read More