Manufacturers and providers have “perverse incentives” to set higher drug prices and pick pricier therapies for patients due to Medicare’s current payment structure, and the system isn’t suitable for expensive…
The FDA outlined its latest thinking on granting exemptions from drug supply chain security requirements in a new draft guidance. Source: Drug Industry Daily
Prescription drug wholesaler executives were largely evasive in response to questioning about their responsibility for the opioid crisis in a contentious House subcommittee hearing Tuesday. Source: Drug Industry Daily
The Drug Enforcement Administration has ordered a Shreveport, Louisiana wholesale pharmaceutical distributor to cease sales of opioids alleging that it failed to report large, suspicious orders to drugstores. Source: Drug…
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The FDA has withdrawn its direct final rule to amend biologics inspection regulations and will rewrite it, the agency announced Friday.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…