Significant price cuts would be needed for three Vertex cystic fibrosis drugs to deliver benefits equal to their cost, according to an analysis by the Institute of Clinical and Economic…
The European Medicines Agency issued a report card on the first two years of its Priority Medicines (PRIME) Scheme, highlighting that it has received and processed 177 requests for eligibility…
District court ANDA case filings last year increased by nearly 30 percent from 2016, according to an annual report from Lex Machina. Source: Drug Industry Daily
The FDA has withdrawn its direct final rule to amend biologics inspection regulations and will rewrite it, the agency announced Friday. Source: Drug Industry Daily
Most litigation against opioid manufacturers has focused on accusations of fraud or misleading marketing that they claim contributed to the addiction crisis, but a new class-action suit holds them responsible…
Synthetic opioids have overtaken prescription opioids as the leading cause of overdose deaths in the U.S., according to a report published by the Journal of the American Medical Association, which…
The FDA is on track to complete standardized inspection agreements with every nation in the European Union next summer, one of the agency’s top international officials said Friday. Source: Drug…
The FDA has cut the amount of time it takes to issue post-inspection classification letters nearly in half over the past three years, one of the agency’s top inspection officials…
The Clinical Trials Transformation Initiative is developing several new sets of recommendations relating to clinical trials — on the qualification of investigators, the potential legal and regulatory hurdles to decentralized…
The EMA noted a steep decrease in GMP inspections in its annual report for 2017, as well as a hike in inspections for good clinical practices and nearly double the…