National Law Review

CMS Proposes GLOBE and GUARD Drug Pricing Models to Reduce Medicare Costs

CMS has proposed two mandatory Medicare drug pricing models: the GLOBE Model (for Part B drugs) and the GUARD Model (for Part ...
JD Supra

340B Drug Rebate Models: Status and Litigation Update

Four drug manufacturers have announced plans to offer discounted drug prices to safety net providers under the federal 340B program via rebates instead of upfront discounts, despite the federal ...

HHS Reconsidering Drug Rebate Pilot Opposed by Hospitals (1)

The US Department of Health and Human Services is negotiating with hospital groups about reconsidering a new drug rebate pilot that was scheduled to take effect Jan. 1, according to filings in a ...
Forbes

Adoption Of Model-Informed Drug Development Can Improve Pharma ROI

Inflation and the Covid-19 pandemic have put pharmaceutical productivity front and center in recent years. Thus, drug companies are under mounting pressure to prove that new treatments are safe and ...
American Enterprise Institute

Modeling Drug Development: Improvements Still Needed

The Congressional Budget Office (CBO) informs Congress about the costs or revenue changes associated with proposed legislation, a challenging enough task on its own. Sometimes, the CBO is asked to ...
JD Supra

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI)[1] models in drug development and in regulatory submissions titled, ...