Product hopping, patent manipulation, patient assistance programs and pay-for-delay are all points of inquiry in Sen. Bernie Sanders and fellow HELP Democrats latest drug pricing investigation, which targets pricey inhalers that have gone decades without generic competition.
Four brand drug companies are coming under the scrutiny of Sen. Bernie Sanders and other Democrats for the high prices of asthma inhalers and the potential anticompetitive tactics the companies may have used to keep cheaper competition from the market.
It’s not great news for the named players – AstraZeneca PLC, Boehringer Ingelheim GmbH, GSK plc, and...
Create an account to read this article
Already a subscriber?
The FDA recommended sponsors plan ahead for potential issues if overall survival is not feasible as a primary or secondary efficacy endpoint in clinical trials and must be analyzed as a safety outcome.
The CDC’s current shared clinical decision-making recommendation for vaccinating healthy children age six months and older should trigger full coverage under the Affordable Care Act, but is not always happening at pharmacies and doctors’ offices, an Epstein Becker attorney said.
After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.
Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.
The White House is directing the Health and Human Services Department to replenish stockpiles of active pharmaceutical ingredients for “especially critical” medicines.
Newly implemented IRA provisions may not necessarily lower drug costs for those enrolled in Medicare Part D plans, according to research by the USC Schaeffer Center for Health Policy and Economics.
Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.
