US

From ACIP to Part D to data transparency, GSK has several policy asks as it prepares to launch its new RSV vaccine for older adults. The Pink Sheet spoke with GSK’s vaccine policy lead about the firm’s new data platform and the worrisome US vaccination trends following the Covid pandemic.

Lack of detail on data elements that would be required through the portal has stakeholders wondering if the Centers for Medicare and Medicaid Services has really found a way to make the registry requirement less of a threat to access for Alzheimer’s drugs with traditional FDA approval.

In unanimous decision, court backs whistleblowers’ fraud theory that SuperValu and Safeway defrauded Medicare and Medicaid by reporting higher retail prices than their discounted prices. BIO, AdvaMed and MIWG submitted amicus brief in support of the retail pharmacies.

CBER’s Marks said US FDA is working with Novavax on manufacturing to allow its protein-based vaccine to be ready for a fall roll-out. After some concerns about international coordination, multiple regulators seem to be settling on a monovalent approach for fall vaccinations.

Sotagliflozin’s cardiovascular outcomes trials support the most expansive heart failure risk reduction claim approved by the US FDA in the class, a turnaround from the drug’s setbacks in type 1 diabetes.

Remediation of a problem with FDA is one factor the DOJ considers in assessing whether a company gets credit for self-disclosure of misconduct prior to a criminal investigation, but it wants companies to come directly to the department to divulge wrongdoing.

US Department of Veterans Affairs' head for pharmacy benefits management says her agency’s coverage of Leqembi and Aduhelm is actually closely aligned with that provided by Medicare, in contrast to the initial characterization of the VA taking a different stance on the drugs.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

After decades of work, the US FDA released proposed requirements for a simplified version of the Medication Guide for all products. Electronic distribution in lieu of paper ‘upon a patient’s request’ would be allowed. Comments sought on the value of consumer testing of the documents.

Accelerated approval for primary biliary cholangitis in 2016 came with three postmarketing requirements, but studies were terminated early; firm working toward sNDA submission in 2023 for regular approval, but US FDA says reports already are overdue and it expects to take PBC indication back to an adcomm.

Pink Sheet reporters and editors discuss the largest pharma companies’ pending applications, the FDA delaying its decision on Sarepta’s gene therapy in Duchenne muscular dystrophy, and a plan to add more temporary members to agency advisory committees … as well as a little bit of “The Simpsons.”

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.