Drug Industry Daily

Eli Lilly’s generic insulin Lispro can cost nearly four times as much as the company’s promised price of $25 per vial, according to a new report from Democratic Senators Elizabeth Warren (Mass.), Raphael Warnock (Ga.) and Richard Blumenthal (Conn). Source: Drug Industry Daily

With COVID-19 vaccines moving to the open market postpandemic, their manufacturers should remember the support they received from the federal government when setting prices, said HHS Secretary Xavier Becerra in an open letter to COVID-19 vaccine manufacturers. Source: Drug Industry Daily

The U.S. Chamber of Commerce and three other chambers have filed a motion for a preliminary injunction preventing implementation of the Drug Price Negotiation Program in the Inflation Reduction Act (IRA) because it violates the Fifth Amendment Due Process Clause. Source: Drug Industry Daily

The FTC will continue its ongoing examination of the pharmacy benefit management (PBM) industry at an open meeting July 20 when it decides whether to issue a warning to PBMs to stop relying on older FTC advocacy materials that opposed mandatory PBM transparency and disclosure requirements. Source: Drug Industry Daily

Over the past week, the FDA has issued draft guidances on inborn errors of metabolism, clinical trial postmarketing studies and human cellular and gene therapy products. Source: Drug Industry Daily

In an effort to improve adherence with postmarketing requirements (PMR), the FDA has laid out the circumstances under which noncompliance with PMRs is justified in a new draft guidance. Source: Drug Industry Daily

Acknowledging the complexity of human cellular and gene therapy (CGT) products, the FDA has written a draft guidance intended to help manufacturers manage and report changes in products, based on a lifecycle approach, and how to assess the effect of manufacturing changes on product quality. Source: Drug Industry Daily

Merck has asked a federal judge to issue an order granting a summary judgment in its case against HHS over the Inflation Reduction Act (IRA) on the grounds that “no genuine issue as to any material fact exists.” Source: Drug Industry Daily

A revised report from the Institute for Clinical Evaluation and Research (ICER) has reiterated that two experimental gene therapies for sickle cell disease (SCD) would likely be cost-effective if priced at $2 million. Source: Drug Industry Daily

FDA’s decision to approve the OTC status of the birth control pill is a real milestone in the evolution of Rx-to-OTC switches. Source: Drug Industry Daily