Archive for July 2024

Manufacturers of laboratory-developed tests (LDT) are concerned that the FDA will lack the resources to deal with a flood of premarket approval applications as the agency implements its recent final rule asserting oversight of LDTs as medical devices. Source: Drug Industry Daily

A new analysis by Milliman commissioned by PhRMA indicates that 3.5 million Medicare Part D beneficiaries could face an average 12 percent increase in annual out-of-pocket costs in 2026 due to the Inflation Reduction Act’s (IRA) drug pricing provisions. Source: Drug Industry Daily

The FDA on Tuesday approved Kisunla (donanemab-azbt), Eli Lilly’s once-monthly injection for adults with early symptomatic Alzheimer’s disease (AD), along with earlier approvals of four other drugs for various conditions. Source: Drug Industry Daily

The FDA has issued a complete response letter (CRL) to Rocket Pharmaceuticals requesting additional chemistry, manufacturing and controls (CMC) information before reviewing the company’s BLA for Kresladi (marnetegragene autotemcel). Source: Drug Industry Daily

The Supreme Court voted 6-3 on Monday to lay out a new standard that makes it easier for companies and other entities to challenge federal rules, potentially allowing new challenges to regulations that have been in place for decades. Source: Drug Industry Daily

CDRH has again expanded the Total Product Life Cycle Advisory Program (TAP), adding devices reviewed in three additional FDA offices. Source: Drug Industry Daily

Three former executives of Chicago-based tech startup Outcome Health have been sentenced for their roles in a six-year scheme involving approximately $1 billion in fraudulently obtained funds gained from a pharmaceutical advertising scheme. Source: Drug Industry Daily

Hoau-Yan Wang, a former paid consultant at Cassava Science and professor at the City University of New York (CUNY), is now the subject of a federal indictment charging that he milked the NIH for $16 million in grant money based on falsified data. Source: Drug Industry Daily

The Supreme Court’s reversal of a 40-year-old precedent that had smoothed the regulatory agency pathway now makes it easier for courts to step in with their own interpretation of a law’s effect on regulatory issues. Source: Drug Industry Daily

The FDA has published overdue draft guidance on developing diversity action plans for clinical trials, moving the agency a step closer to the statutory mandate that all phase 3 trials include such plans. Source: Drug Industry Daily