FDA Commissioner Scott Gottlieb said pharmacy benefit managers may be “complacent participants” in schemes to stifle biosimilar competition and raise drug prices by keeping cheaper versions of drugs off the…
Clinical trials for depot buprenorphine products for opioid dependence treatment should not focus on standard endpoints, but also consider novel efficacy endpoints not directly focused on opioid use, according to…
The federal government issued a notice of proposed rulemaking that would postpone its revisions to the Common Rule on the use of human subjects in clinical trials for another six…
Sixteen Democratic and independent senators wrote to HHS Secretary Alex Azar urging him to negotiate lower prices for the opioid overdose reversal drug naloxone. Source: Drug Industry Daily
An FDA advisory committee voted unanimously to recommend approval of a drug for Lennox-Gastaut syndrome and Dravet syndrome that, if approved, would be the first FDA-approved cannabis-derived product, GW Pharma’s…
The FDA released final guidance on its Q7 guidelines on good manufacturing practices for APIs, using a question and answer format to clarify the document developed through the International Conference…
A California appeals court revived a lawsuit against GlaxoSmithKline in which the plaintiffs claimed the company failed to properly warn non-English speakers about the risks of its antidiabetic drug Avandia…
Drug manufacturers found to be fueling the opioid crisis would face marketing limitations and stiff fines under legislation introduced by Sen. Bernie Sanders (I-Vt.). Source: Drug Industry Daily
The Drug Enforcement Administration proposes to limit the production of opioids when setting production quotas by taking into account how often the prescribed drugs are illegally diverted from the individuals…
After experiencing a steep decline early in 2018, generic drug approvals by the FDA are climbing back towards last year’s highs according to the latest FDA report. Source: Drug Industry…