Archive for July 2023

Industry trade group PhRMA has filed a complaint in district court alleging that Louisiana’s law requiring drugmakers to provide 340B drug discounts to contract pharmacies violates federal statute. Source: Drug Industry Daily

Citius Pharmaceuticals’ BLA for its lymphoma drug Lymphir (denileukin diftitox) has hit a setback as the company has received a complete response letter (CRL) from the FDA requesting additional testing. Source: Drug Industry Daily

As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Source: Drug Industry Daily

The FDA and EMA have completed the first collaborative assessment of a critical oncology biologic, with the agencies reviewing and approving a proposal to add new manufacturing and quality control sites, the FDA announced on Friday. Source: Drug Industry Daily

The collection, use and submission of patient experience data (PED) still requires significantly more FDA guidance, clarification and support, big-name sponsors told the agency in response to a request for information and comments on the subject. Source: Drug Industry Daily

Friday, Biogen announced that it was planning to acquire Reata for approximately $7.3 billion, while Alexion, AstraZeneca’s rare disease subsidiary, announced that it had entered a purchase and license agreement for a portfolio of preclinical gene therapy programs and technologies from Pfizer. Source: Drug Industry Daily

This week, three medical devices used for cardiac issues were deemed class I by the FDA, the most serious type of recall, as use of the device may cause serious injury or death. Source: Drug Industry Daily

The Senate Finance Committee has advanced a bill seeking to reform pharmacy benefit managers (PBMs) by prohibiting them from deriving compensation for Medicare Part D-covered drugs based on the drug’s list price, among other proposals. Source: Drug Industry Daily

HHS announced plans to issue several FDA-related proposed and final rules in the coming year in its semiannual inventory of rulemaking actions. Source: Drug Industry Daily

Over the past week, the FDA issued final guidance for deoxyribonucleic acid (DNA) reactive impurities in pharmaceuticals, assessing biosimilar user fees, hydrogen peroxide-based contact lens products and CDER’s program for the recognition of voluntary consensus standards guidance on medical device development tools. The FDA 2024 user fees were also announced. Source: Drug Industry Daily