Deputy director of the Bureau of Competition notes in an interview that the FTC focused on older products it felt should have more generic competition in its letters to companies citing improper patent listings. He says it is clear which drug-device combo patents should not be listed.
The US Federal Trade Commission took on a new mission when it issued letters to drug manufactures claiming they improperly listed patents pertaining to drug-device combination products in the US Food and Drug Administration’s Orange Book. Lawyers have questioned why the FTC did so without guidance from FDA on what device patents can be listed.
Rahul Rao, deputy director of FTC’s Bureau of Competition, who wrote the letters, talked to the Pink Sheet about why...
Before J&J’s former chief data scientist Najat Khan moved to Recursion, she talked to the Pink Sheet about how AI is transforming trials and driving collaboration between industry and regulators.
The payor’s multiyear plan to ditch the traditional PBM model and use multiple vendors has drawn a lot of skepticism from other actors in the health care system, but Blue Shield is hoping that it can help give policymakers some momentum, VP Lum tells the Pink Sheet.
As Hatch-Waxman celebrates its 40th anniversary, the chair of the US generic trade association talks about striking the right balance on supply and pricing, preventing shortages, and improving Medicare price negotiations.
In an interview, Sarah Emond talks about why she is ‘worried’ about cell and gene therapy, when ICER might revise its assessment of obesity drugs, and how CMS could build a reliable and transparent Medicare price negotiation program.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.
