A bipartisan group of lawmakers urged the White House to push for action to prevent, treat and ultimately eradicate tuberculosis at an upcoming United Nations meeting. Source: Drug Industry Daily
The Justice Department filed notice that it plans to intervene in four False Claims Act lawsuits accusing Indivior and Reckitt of improperly marketing the opioid anti-addiction drug Suboxone. Source: Drug…
The FDA says sponsors considering adaptive studies for early phase cancer treatments should focus on patients with no other options. Source: Drug Industry Daily
Taking aim at illicit synthetic opioid distribution, the Department of Justice is launching a Florida operation to prosecute every case of illegal distribution. Source: Drug Industry Daily
A Celltrion plant based in Incheon City, South Korea, was hit again by the FDA for violations observed during an inspection last month following a February warning letter. Source: Drug…
The Louisiana Department of Health is considering subscription-based payments for manufacturers of hepatitis C drugs as a way to control the state’s spending on drugs and to serve more Medicaid…
The HHS Office of Inspector General flagged “questionable billing” and rapid growth in Medicare Part D spending for compounded topical drugs in a report released Thursday. Source: Drug Industry Daily
AstraZeneca has agreed to pay $110 million to settle two lawsuits filed against it by the state of Texas alleging the pharmaceutical giant deceitfully marketed two of its drug products…
Insys announced Wednesday it reached an agreement with the Justice Department to pay $150 million over five years to settle allegations that it bribed doctors to prescribe its fentanyl sublingual spray…
The FDA issued final guidance Wednesday on dissolution testing for immediate-release solid oral dosage form drugs containing high solubility substances. Source: Drug Industry Daily