Gauging the 340B drug discount program’s effectiveness requires more price transparency and clearer guidance, expert witnesses told the Senate health committee Tuesday. Source: Drug Industry Daily
In the latest development in the Michael Cohen-Novartis scandal, the U.S. Senate Committee on Finance pressured Novartis CEO Vasant Narasimhan for contracts and communications made between the pharma company and…
A federal appeals court affirmed the dismissal of a lawsuit brought by the nonprofit AIDS Healthcare Foundation (AHF) challenging Gilead’s patents on several of its HIV drugs. Source: Drug Industry…
A process for second appeals of FDA designations for medical product classifications would be eliminated under a new FDA proposed rule. Source: Drug Industry Daily
HHS Secretary Alex Azar offered more details on Monday of a plan that could expand Medicare’s ability to negotiate prices, implicitly responding to claims that the administration’s new drug pricing…
Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products. Source: Drug…
The Department of Justice filed civil complaints in Florida and California to stop two companies offering unapproved stem cell treatments. Source: Drug Industry Daily
Tennessee became just the second state to legalize off-label promotion of drugs, a move drawing praise and some concern from experts. Source: Drug Industry Daily
Sponsors of pediatric HIV drugs should conduct bioequivalence studies in adults and enroll clinical trial subjects in cohorts based on weight rather than age, according to new FDA draft guidance.…
In a long-anticipated speech on drug pricing, President Trump announced reforms that “will bring soaring drug prices back down to earth,” but he cited few specifics and appeared to back…