Here are the latest stories being discussed in biopharma today:
New Jersey Judge’s Decisions Could Influence Other IRA Cases: Experts
Experts suggest that a New Jersey judge’s skepticism of arguments against the Inflation Reduction Act’s drug price negotiations put forward by pharmaceutical companies could influence other courts hearing similar cases. Companies including Bristol Myers Squibb, Johnson & Johnson, Novartis, and Novo Nordisk had argued that the negotiations are unconstitutional, unduly coercive, and a threat to R&D.
CBO Suggests Medicare May Provide Coverage for Obesity Drugs
The Congressional Budget Office (CBO) has hinted that Medicare could soon cover obesity drugs such as Wegovy (Novo Nordisk) and Zepbound (Eli Lilly) due to their cardiovascular benefits. This would fall in line with anticipated costs if the FDA approves GLP-1s for cardiovascular indications.
Viatris and Mapi Looking for Way Forward After FDA Rejects MS Injection
The FDA has handed a complete response letter to Viatris and Mapi Pharma related to their long-acting injection for the treatment of relapsing forms of multiple sclerosis. The companies are currently reviewing the CRL and planning their next steps.
FDA Emphasizes Amyloid in Alzheimer’s R&D Guidance
The FDA has updated its guidance on early Alzheimer’s disease drug development. The new version includes a section that strengthens the case for using amyloid reduction as a surrogate endpoint predictive of clinical benefit.
FDA Budget Increased Under Biden Administration
The Biden administration has proposed a budget increase for the FDA for fiscal year 2025. The total funding for the agency would be $7.2 billion, divided between appropriations and user fees.
UCB Debuts First Campaign for Psoriasis Drug Bimzelx During Oscars
UCB introduced its first direct-to-consumer advertising campaign for the psoriasis drug Bimzelx during the 96th Academy Awards. The “Get Yourself Back” campaign focuses on patient insights such as regaining the confidence to wear shorts or dark colors.
